<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02214212</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000219</org_study_id>
    <nct_id>NCT02214212</nct_id>
  </id_info>
  <brief_title>TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI</brief_title>
  <acronym>TWILIGHT</acronym>
  <official_title>TWILIGHT: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Texas Health Science Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study proposes to investigate how well Bright White Light Therapy will work in the acute&#xD;
      inpatient rehabilitation units for people whom have experienced a traumatic brain injury for&#xD;
      the purpose of treating sleep disruption. Participants will be assessed based on sleep&#xD;
      efficiency, thinking abilities, therapy participation, and perception of fatigue/sleepiness.&#xD;
      In previous studies dim red light has not had the same effects on function as bright white&#xD;
      light, and will be chosen for use as a placebo. Each subject will be randomized to receive 30&#xD;
      minutes of either Bright White Light Therapy or Red Light Treatment each morning for 10 days.&#xD;
&#xD;
      To measure the effect of this treatment, the investigators will measure the each participants&#xD;
      sleep daily by using an actigraph watch. This watch will record movement continuously. The&#xD;
      investigators will also measure the subjects' report of how well they slept, whether fatigue&#xD;
      is present, and how attentive they are before and after treatment.&#xD;
&#xD;
      Research Hypothesis:&#xD;
&#xD;
      In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning&#xD;
      Bright White Light with a comparison group exposed to Red Light in an acute inpatient&#xD;
      rehabilitation setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will recruit persons with moderate to severe traumatic brain injury (TBI)&#xD;
      on admission to intensive rehabilitation units. Consented participants (who meet all&#xD;
      inclusion and exclusion criteria) will wear an actigraphy watch for 2 nights to obtain a&#xD;
      baseline for sleep pattern identification. Prior to treatment, baseline measures (detailed&#xD;
      below) will be obtained. Participants will be randomized to receive either Bright White Light&#xD;
      (BWL) or Red Light (RL) treatment. Light therapy treatments will be given for 30 minutes&#xD;
      daily in the morning for 10 days, and an Actiwatch will be worn continuously during that&#xD;
      period. At the end of 10 days, outcome measures will be obtained (as below). The specific&#xD;
      period of treatment may be affected by the length of stay on the rehabilitation unit. For&#xD;
      lengths of stay less than the 10 days, subjects will receive the intervention until the day&#xD;
      of discharge at which time the outcome measures will be administered. The investigators&#xD;
      primary outcome measure with be the actigraphic measurement of sleep efficiency. Other&#xD;
      secondary measures will be participation in therapy, sleepiness, and attention. The&#xD;
      investigators will also evaluate the anticipated device costs and clinical staff burden&#xD;
      involved in utilizing light therapy exposure in an inpatient rehabilitation clinical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Actigraphy Data</measure>
    <time_frame>Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure</time_frame>
    <description>Sleep efficiency scores derived from actigraphy data will be the primary outcome. We will set the Actiwatch to record activity data in 60-second intervals. Actigraphy data will be automatically scored with Actiware software (Respironics, Philips Healthcare), which uses validated algorithms to determine whether an epoch of activity is &quot;sleep&quot; or &quot;wake&quot; (Cole RJ, 1992). Typically there is a lack of a consistent sleep/wake cycle in the study population, therefore we will be using sleep efficiency and total sleep time scores obtained during a set night-time interval (2200 to 0600) as the primary index of sleep function, as has been used in previous publications[39, 40]. We will be comparing average between group differences between the BWL and RL groups at baseline and after 10 days of light therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barrow Neurological Institute Fatigue Scale (BNI-FS)</measure>
    <time_frame>At Baseline and After 10 Days of Light Exposure</time_frame>
    <description>The Barrow Neurological Institute Fatigue Scale (BNI-FS; Fatigue Outcome) is an 11-point scale that examines fatigue during acute recovery from TBI. Scores on items 1-10 may range from 1 (rarely a problem), 2-3 (occasional problem but not frequent), 4-5 (a frequent problem), 6-7 (a problem most of the time). The last item is a general rating of fatigue from 0 (not a problem) to 10 (a severe problem). The total BNI-FS is a sum of the first 10 items (0-70), where higher scores indicate worse outcome.&#xD;
The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. The clinical staff involved in the care of these subjects were asked to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM) - Motor</measure>
    <time_frame>Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)</time_frame>
    <description>Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symbol Digit Modalities Test</measure>
    <time_frame>Administered at Baseline and After 10 Days of Light Exposure</time_frame>
    <description>The Symbol Digit Modalities Test (SDMT) is a pencil and paper test for attention that takes approximately five minutes to administer and is frequently used in evaluations after TBI. The SDMT was administered at enrollment and after intervention. The Interagency Workgroup on TBI Outcomes selected the SDMT as CORE common data elements in TBI outcomes research. The SDMT measures attention and speed of processing (the test-taker substitutes a number for random presentations of geometric figures). Scoring involves summing the number of correct substitutions within the 90 second interval (min=0, max = 110), with higher scores representing better attention/speed of processing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Schedule - Positive</measure>
    <time_frame>Administered at Baseline and After 10 Days of Light Exposure</time_frame>
    <description>The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Positive is the sum of the 10 positive items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total positive score, a higher score indicates more positive affect. affect. Scores can range from 10-50 for Positive Affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Schedule - Negative</measure>
    <time_frame>Administered at baseline and after 10 days of light exposure</time_frame>
    <description>The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Negative is the sum of the 10 negative items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total negative score, a higher score indicates more negative affect. affect. Scores can range from 10-50 for Negative Affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karolinska Sleepiness Scale (KSS)</measure>
    <time_frame>Administered at Baseline and after 10 Days of Light Exposure</time_frame>
    <description>The Karolinska Sleepiness Scale (KSS; Sleepiness Outcome) is a single-question with a 9-point Likert scale (1 = extremely alert, 9 = extremely sleepy, fighting sleep) measuring subjective sleepiness at the time of report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Makley Scale</measure>
    <time_frame>A sleep log was completed every 2 hours during the night (2200 until 0600) on each patient by the unit nursing staff hours for 12 nights or until discharge from the hospital (2 nights baseline and after 10 nights of intervention light exposure)</time_frame>
    <description>The Makley scale is a 4-point ordinal scale which allows staff to score sleep as follows:&#xD;
0 = asleep; 1 = drowsy/falling asleep; 2 = drowsy/waking up; 3 = awake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM) - Cognitive</measure>
    <time_frame>Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)</time_frame>
    <description>Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cooperation Measure (Therapy Outcome)</measure>
    <time_frame>Collected at Baseline and after 10 days of light exposure</time_frame>
    <description>Cooperation Measure (Therapy Outcome). Patient cooperation was rated using a visual analogue scale (VAS) ranging from 0%-not cooperative to 100%- fully cooperative.10 Staff physical therapists were asked to rate cooperation both prior to initiation and after completion of phototherapy.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>TBI</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Red Light (RL)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bright White Light (BWL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bright White Light (BWL)</intervention_name>
    <description>The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
    <arm_group_label>Bright White Light (BWL)</arm_group_label>
    <other_name>Litebook® (Bright White Light)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Red Light (RL)</intervention_name>
    <description>The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
    <arm_group_label>Red Light (RL)</arm_group_label>
    <other_name>Litebook® (Red Light)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have experienced a moderate to severe TBI.&#xD;
&#xD;
        Defined by any of the following:&#xD;
&#xD;
          1. Loss of Consciousness greater than 30 minutes.&#xD;
&#xD;
          2. Emergency Room admission with a Glasgow Coma Scale of 12 or below.&#xD;
&#xD;
          3. Intracranial abnormalities on imaging.&#xD;
&#xD;
          4. Post-traumatic amnesia that lasts more than 24 hours.&#xD;
&#xD;
               -  Admitted to acute inpatient rehabilitation unit at Harborview Medical Center&#xD;
                  within 3 months of their Traumatic Brain Injury.&#xD;
&#xD;
               -  Able to communicate in English.&#xD;
&#xD;
               -  Between the ages of 18 and 70 years old&#xD;
&#xD;
               -  Have a clinician rating of the presence of a sleep disturbance (using the Makley&#xD;
                  scale)&#xD;
&#xD;
               -  Have some vision in one or both eyes.&#xD;
&#xD;
               -  Have a Body Mass Index lower than 40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Unable to enroll if any of the following are true&#xD;
&#xD;
          -  Complete blindness&#xD;
&#xD;
          -  Absence of eye opening or disorders of consciousness (Rancho level 1-3).&#xD;
&#xD;
          -  Tetraplegia with less than antigravity strength in all myotomes caudal to C6 level&#xD;
             given the limitations on measuring movements with actigraphy in this population (i.e.&#xD;
             cannot reliably detect upper extremity or lower extremity movement with this level of&#xD;
             paralysis).&#xD;
&#xD;
          -  Past medical history of retinal pathology&#xD;
&#xD;
          -  Past medical history of light sensitivity&#xD;
&#xD;
          -  Past medical history of narcolepsy&#xD;
&#xD;
          -  Past medical history of bipolar disorder&#xD;
&#xD;
          -  Past medical history of obstructive sleep apnea&#xD;
&#xD;
          -  Suspected sleep apnea. (Determined by administering the Berlin questionnaire)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanne M Hoffman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>May 20, 2021</results_first_submitted>
  <results_first_submitted_qc>October 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2021</results_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Jeanne Hoffman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>traumatic brain injury</keyword>
  <keyword>TBI</keyword>
  <keyword>Sleep</keyword>
  <keyword>Bright White Light Therapy</keyword>
  <keyword>Red Light Therapy</keyword>
  <keyword>Recovery</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Nervous System Diseases</keyword>
  <keyword>Signs and Symptoms</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Actigraphy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 2, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT02214212/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Red Light (RL)</title>
          <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
        </group>
        <group group_id="P2">
          <title>Bright White Light (BWL)</title>
          <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Red Light (RL)</title>
          <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
        </group>
        <group group_id="B2">
          <title>Bright White Light (BWL)</title>
          <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="66"/>
            <count group_id="B2" value="65"/>
            <count group_id="B3" value="131"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.1" spread="2.7"/>
                    <measurement group_id="B2" value="39.8" spread="2.6"/>
                    <measurement group_id="B3" value="41" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25-39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>55+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13" spread="2.3"/>
                    <measurement group_id="B2" value="14" spread="2.5"/>
                    <measurement group_id="B3" value="13.5" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Single</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Div/Sep/Widow</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cause of Injury</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Vehicular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Violence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pedestrian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Actigraphy Data</title>
        <description>Sleep efficiency scores derived from actigraphy data will be the primary outcome. We will set the Actiwatch to record activity data in 60-second intervals. Actigraphy data will be automatically scored with Actiware software (Respironics, Philips Healthcare), which uses validated algorithms to determine whether an epoch of activity is &quot;sleep&quot; or &quot;wake&quot; (Cole RJ, 1992). Typically there is a lack of a consistent sleep/wake cycle in the study population, therefore we will be using sleep efficiency and total sleep time scores obtained during a set night-time interval (2200 to 0600) as the primary index of sleep function, as has been used in previous publications[39, 40]. We will be comparing average between group differences between the BWL and RL groups at baseline and after 10 days of light therapy.</description>
        <time_frame>Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure</time_frame>
        <population>Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 117 (or 89%) and a breakdown between groups for light exposure of 57=Red Light and 60=Bright White Light.</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>The Red Light group was exposed to RL (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>The intervention group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
        </group_list>
        <measure>
          <title>Actigraphy Data</title>
          <description>Sleep efficiency scores derived from actigraphy data will be the primary outcome. We will set the Actiwatch to record activity data in 60-second intervals. Actigraphy data will be automatically scored with Actiware software (Respironics, Philips Healthcare), which uses validated algorithms to determine whether an epoch of activity is &quot;sleep&quot; or &quot;wake&quot; (Cole RJ, 1992). Typically there is a lack of a consistent sleep/wake cycle in the study population, therefore we will be using sleep efficiency and total sleep time scores obtained during a set night-time interval (2200 to 0600) as the primary index of sleep function, as has been used in previous publications[39, 40]. We will be comparing average between group differences between the BWL and RL groups at baseline and after 10 days of light therapy.</description>
          <population>Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 117 (or 89%) and a breakdown between groups for light exposure of 57=Red Light and 60=Bright White Light.</population>
          <units>percentage of sleep efficiency (0-100)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="17"/>
                    <measurement group_id="O2" value="76" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 days of light exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="11"/>
                    <measurement group_id="O2" value="77" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.955</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.69</ci_lower_limit>
            <ci_upper_limit>5.37</ci_upper_limit>
            <estimate_desc>The reported effect size has been expressed as the modelled difference in sleep efficiency improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Barrow Neurological Institute Fatigue Scale (BNI-FS)</title>
        <description>The Barrow Neurological Institute Fatigue Scale (BNI-FS; Fatigue Outcome) is an 11-point scale that examines fatigue during acute recovery from TBI. Scores on items 1-10 may range from 1 (rarely a problem), 2-3 (occasional problem but not frequent), 4-5 (a frequent problem), 6-7 (a problem most of the time). The last item is a general rating of fatigue from 0 (not a problem) to 10 (a severe problem). The total BNI-FS is a sum of the first 10 items (0-70), where higher scores indicate worse outcome.&#xD;
The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. The clinical staff involved in the care of these subjects were asked to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.</description>
        <time_frame>At Baseline and After 10 Days of Light Exposure</time_frame>
        <population>Statistical significance by mixed-effects regression adjusting for site, FIM admit cognitive, FIM admit motor. (Incident and education did not improve any of the models.) Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 116 (or 88%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>The Red Light group was exposed to RL (comparator) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>The intervention group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
        </group_list>
        <measure>
          <title>Barrow Neurological Institute Fatigue Scale (BNI-FS)</title>
          <description>The Barrow Neurological Institute Fatigue Scale (BNI-FS; Fatigue Outcome) is an 11-point scale that examines fatigue during acute recovery from TBI. Scores on items 1-10 may range from 1 (rarely a problem), 2-3 (occasional problem but not frequent), 4-5 (a frequent problem), 6-7 (a problem most of the time). The last item is a general rating of fatigue from 0 (not a problem) to 10 (a severe problem). The total BNI-FS is a sum of the first 10 items (0-70), where higher scores indicate worse outcome.&#xD;
The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. The clinical staff involved in the care of these subjects were asked to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.</description>
          <population>Statistical significance by mixed-effects regression adjusting for site, FIM admit cognitive, FIM admit motor. (Incident and education did not improve any of the models.) Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 116 (or 88%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="15.6"/>
                    <measurement group_id="O2" value="26.5" spread="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 days of light exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="13.0"/>
                    <measurement group_id="O2" value="18.3" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.807</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.90</ci_lower_limit>
            <ci_upper_limit>6.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Independence Measure (FIM) - Motor</title>
        <description>Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91.</description>
        <time_frame>Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)</time_frame>
        <population>Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 124 (or 95%). The Functional Independence Measure (FIM) was completed at Rehab Admit and again at Rehab Discharge.</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Independence Measure (FIM) - Motor</title>
          <description>Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91.</description>
          <population>Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 124 (or 95%). The Functional Independence Measure (FIM) was completed at Rehab Admit and again at Rehab Discharge.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FIM Motor -Rehab Admit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" spread="18.9"/>
                    <measurement group_id="O2" value="38.5" spread="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM Motor - Rehab Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.2" spread="16.0"/>
                    <measurement group_id="O2" value="69.8" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.847</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.38</ci_lower_limit>
            <ci_upper_limit>4.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symbol Digit Modalities Test</title>
        <description>The Symbol Digit Modalities Test (SDMT) is a pencil and paper test for attention that takes approximately five minutes to administer and is frequently used in evaluations after TBI. The SDMT was administered at enrollment and after intervention. The Interagency Workgroup on TBI Outcomes selected the SDMT as CORE common data elements in TBI outcomes research. The SDMT measures attention and speed of processing (the test-taker substitutes a number for random presentations of geometric figures). Scoring involves summing the number of correct substitutions within the 90 second interval (min=0, max = 110), with higher scores representing better attention/speed of processing.</description>
        <time_frame>Administered at Baseline and After 10 Days of Light Exposure</time_frame>
        <population>Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 79 participants (or 60%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>The Red Light group was exposed to RL (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>The intervention group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
        </group_list>
        <measure>
          <title>Symbol Digit Modalities Test</title>
          <description>The Symbol Digit Modalities Test (SDMT) is a pencil and paper test for attention that takes approximately five minutes to administer and is frequently used in evaluations after TBI. The SDMT was administered at enrollment and after intervention. The Interagency Workgroup on TBI Outcomes selected the SDMT as CORE common data elements in TBI outcomes research. The SDMT measures attention and speed of processing (the test-taker substitutes a number for random presentations of geometric figures). Scoring involves summing the number of correct substitutions within the 90 second interval (min=0, max = 110), with higher scores representing better attention/speed of processing.</description>
          <population>Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 79 participants (or 60%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" spread="13.3"/>
                    <measurement group_id="O2" value="21.6" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 days light exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="14.4"/>
                    <measurement group_id="O2" value="29.0" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.252</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Statistical significance by mixed-effects regression adjusts for time (pre/post), site, FIM admit cognitive, FIM admit motor as fixed effects.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.29</ci_lower_limit>
            <ci_upper_limit>8.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive and Negative Affect Schedule - Positive</title>
        <description>The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Positive is the sum of the 10 positive items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total positive score, a higher score indicates more positive affect. affect. Scores can range from 10-50 for Positive Affect.</description>
        <time_frame>Administered at Baseline and After 10 Days of Light Exposure</time_frame>
        <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 118 participants (or 90%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Affect Schedule - Positive</title>
          <description>The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Positive is the sum of the 10 positive items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total positive score, a higher score indicates more positive affect. affect. Scores can range from 10-50 for Positive Affect.</description>
          <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 118 participants (or 90%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8" spread="9.0"/>
                    <measurement group_id="O2" value="30.9" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 Days of Light Exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" spread="8.8"/>
                    <measurement group_id="O2" value="34.2" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.722</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.08</ci_lower_limit>
            <ci_upper_limit>4.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive and Negative Affect Schedule - Negative</title>
        <description>The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Negative is the sum of the 10 negative items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total negative score, a higher score indicates more negative affect. affect. Scores can range from 10-50 for Negative Affect.</description>
        <time_frame>Administered at baseline and after 10 days of light exposure</time_frame>
        <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 119 participants (or 91%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Affect Schedule - Negative</title>
          <description>The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Negative is the sum of the 10 negative items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total negative score, a higher score indicates more negative affect. affect. Scores can range from 10-50 for Negative Affect.</description>
          <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 119 participants (or 91%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="8.7"/>
                    <measurement group_id="O2" value="19.6" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 days of light exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="8.6"/>
                    <measurement group_id="O2" value="17.1" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.253</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.13</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Karolinska Sleepiness Scale (KSS)</title>
        <description>The Karolinska Sleepiness Scale (KSS; Sleepiness Outcome) is a single-question with a 9-point Likert scale (1 = extremely alert, 9 = extremely sleepy, fighting sleep) measuring subjective sleepiness at the time of report.</description>
        <time_frame>Administered at Baseline and after 10 Days of Light Exposure</time_frame>
        <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 121 participants (or 92%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
        </group_list>
        <measure>
          <title>Karolinska Sleepiness Scale (KSS)</title>
          <description>The Karolinska Sleepiness Scale (KSS; Sleepiness Outcome) is a single-question with a 9-point Likert scale (1 = extremely alert, 9 = extremely sleepy, fighting sleep) measuring subjective sleepiness at the time of report.</description>
          <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 121 participants (or 92%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="1.8"/>
                    <measurement group_id="O2" value="4.1" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 Days of Light Exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="2.0"/>
                    <measurement group_id="O2" value="3.7" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.351</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.21</ci_lower_limit>
            <ci_upper_limit>0.44</ci_upper_limit>
            <estimate_desc>A positive effect size indicates a higher score in the bright white light (BWL) intervention arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Makley Scale</title>
        <description>The Makley scale is a 4-point ordinal scale which allows staff to score sleep as follows:&#xD;
0 = asleep; 1 = drowsy/falling asleep; 2 = drowsy/waking up; 3 = awake.</description>
        <time_frame>A sleep log was completed every 2 hours during the night (2200 until 0600) on each patient by the unit nursing staff hours for 12 nights or until discharge from the hospital (2 nights baseline and after 10 nights of intervention light exposure)</time_frame>
        <population>1:1 comparison; Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 117 participants (or 89%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Makley Scale</title>
          <description>The Makley scale is a 4-point ordinal scale which allows staff to score sleep as follows:&#xD;
0 = asleep; 1 = drowsy/falling asleep; 2 = drowsy/waking up; 3 = awake.</description>
          <population>1:1 comparison; Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 117 participants (or 89%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" spread="0.38"/>
                    <measurement group_id="O2" value="0.67" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 Days of Light Exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.29"/>
                    <measurement group_id="O2" value="0.61" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.910</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>The reported effect size has been expressed as the modelled difference in the Makley scale score improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Independence Measure (FIM) - Cognitive</title>
        <description>Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35.</description>
        <time_frame>Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)</time_frame>
        <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 124 participants (or 95%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Independence Measure (FIM) - Cognitive</title>
          <description>Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35.</description>
          <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 124 participants (or 95%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FIM Cognitive- Admit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" spread="6.9"/>
                    <measurement group_id="O2" value="14.3" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM Cognitive-Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7" spread="5.7"/>
                    <measurement group_id="O2" value="24.1" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed-effects model adjusts for treatment time (pre/post)</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>.857</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.93</ci_lower_limit>
            <ci_upper_limit>2.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cooperation Measure (Therapy Outcome)</title>
        <description>Cooperation Measure (Therapy Outcome). Patient cooperation was rated using a visual analogue scale (VAS) ranging from 0%-not cooperative to 100%- fully cooperative.10 Staff physical therapists were asked to rate cooperation both prior to initiation and after completion of phototherapy.</description>
        <time_frame>Collected at Baseline and after 10 days of light exposure</time_frame>
        <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 123 participants (or 94%).</population>
        <group_list>
          <group group_id="O1">
            <title>Red Light (RL)</title>
            <description>This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
          <group group_id="O2">
            <title>Bright White Light (BWL)</title>
            <description>This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooperation Measure (Therapy Outcome)</title>
          <description>Cooperation Measure (Therapy Outcome). Patient cooperation was rated using a visual analogue scale (VAS) ranging from 0%-not cooperative to 100%- fully cooperative.10 Staff physical therapists were asked to rate cooperation both prior to initiation and after completion of phototherapy.</description>
          <population>Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 123 participants (or 94%).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.3" spread="27.3"/>
                    <measurement group_id="O2" value="84.5" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 10 Days of Light Exposure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.6" spread="23.0"/>
                    <measurement group_id="O2" value="89.4" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.345</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed-effects model adjusts for treatment, time (pre/post), FIM admit cognitive, site, FIM admit motor as mixed effects.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.83</ci_lower_limit>
            <ci_upper_limit>5.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Event Reporting Period The study period during which adverse events were reported was the period from the initiation of study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up was 2 days following the last study treatment (Day 15).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Red Light (RL)</title>
          <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Red Light (RL): The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
        </group>
        <group group_id="E2">
          <title>Bright White Light (BWL)</title>
          <description>Intervention/Device:&#xD;
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.&#xD;
Bright White Light (BWL): The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jeanne Hoffman</name_or_title>
      <organization>University of Washington</organization>
      <phone>2062216511</phone>
      <email>jeanneh@u.washington.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02214212
org study id: STUDY00000219
nct id: NCT02214212
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study proposes to investigate how well Bright White Light Therapy will work in the acute
      inpatient rehabilitation units for people whom have experienced a traumatic brain injury for
      the purpose of treating sleep disruption. Participants will be assessed based on sleep
      efficiency, thinking abilities, therapy participation, and perception of fatigue/sleepiness.
      In previous studies dim red light has not had the same effects on function as bright white
      light, and will be chosen for use as a placebo. Each subject will be randomized to receive 30
      minutes of either Bright White Light Therapy or Red Light Treatment each morning for 10 days.

      To measure the effect of this treatment, the investigators will measure the each participants
      sleep daily by using an actigraph watch. This watch will record movement continuously. The
      investigators will also measure the subjects' report of how well they slept, whether fatigue
      is present, and how attentive they are before and after treatment.

      Research Hypothesis:

      In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning
      Bright White Light with a comparison group exposed to Red Light in an acute inpatient
      rehabilitation setting.
The investigators will recruit persons with moderate to severe traumatic brain injury (TBI)
      on admission to intensive rehabilitation units. Consented participants (who meet all
      inclusion and exclusion criteria) will wear an actigraphy watch for 2 nights to obtain a
      baseline for sleep pattern identification. Prior to treatment, baseline measures (detailed
      below) will be obtained. Participants will be randomized to receive either Bright White Light
      (BWL) or Red Light (RL) treatment. Light therapy treatments will be given for 30 minutes
      daily in the morning for 10 days, and an Actiwatch will be worn continuously during that
      period. At the end of 10 days, outcome measures will be obtained (as below). The specific
      period of treatment may be affected by the length of stay on the rehabilitation unit. For
      lengths of stay less than the 10 days, subjects will receive the intervention until the day
      of discharge at which time the outcome measures will be administered. The investigators
      primary outcome measure with be the actigraphic measurement of sleep efficiency. Other
      secondary measures will be participation in therapy, sleepiness, and attention. The
      investigators will also evaluate the anticipated device costs and clinical staff burden
      involved in utilizing light therapy exposure in an inpatient rehabilitation clinical setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Actigraphy Data
time frame: Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure
description: Sleep efficiency scores derived from actigraphy data will be the primary outcome. We will set the Actiwatch to record activity data in 60-second intervals. Actigraphy data will be automatically scored with Actiware software (Respironics, Philips Healthcare), which uses validated algorithms to determine whether an epoch of activity is "sleep" or "wake" (Cole RJ, 1992). Typically there is a lack of a consistent sleep/wake cycle in the study population, therefore we will be using sleep efficiency and total sleep time scores obtained during a set night-time interval (2200 to 0600) as the primary index of sleep function, as has been used in previous publications[39, 40]. We will be comparing average between group differences between the BWL and RL groups at baseline and after 10 days of light therapy.
measure: Barrow Neurological Institute Fatigue Scale (BNI-FS)
time frame: At Baseline and After 10 Days of Light Exposure
description: The Barrow Neurological Institute Fatigue Scale (BNI-FS; Fatigue Outcome) is an 11-point scale that examines fatigue during acute recovery from TBI. Scores on items 1-10 may range from 1 (rarely a problem), 2-3 (occasional problem but not frequent), 4-5 (a frequent problem), 6-7 (a problem most of the time). The last item is a general rating of fatigue from 0 (not a problem) to 10 (a severe problem). The total BNI-FS is a sum of the first 10 items (0-70), where higher scores indicate worse outcome.
The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. The clinical staff involved in the care of these subjects were asked to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.
measure: Functional Independence Measure (FIM) - Motor
time frame: Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)
description: Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91.
measure: Symbol Digit Modalities Test
time frame: Administered at Baseline and After 10 Days of Light Exposure
description: The Symbol Digit Modalities Test (SDMT) is a pencil and paper test for attention that takes approximately five minutes to administer and is frequently used in evaluations after TBI. The SDMT was administered at enrollment and after intervention. The Interagency Workgroup on TBI Outcomes selected the SDMT as CORE common data elements in TBI outcomes research. The SDMT measures attention and speed of processing (the test-taker substitutes a number for random presentations of geometric figures). Scoring involves summing the number of correct substitutions within the 90 second interval (min=0, max = 110), with higher scores representing better attention/speed of processing.
measure: Positive and Negative Affect Schedule - Positive
time frame: Administered at Baseline and After 10 Days of Light Exposure
description: The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Positive is the sum of the 10 positive items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total positive score, a higher score indicates more positive affect. affect. Scores can range from 10-50 for Positive Affect.
measure: Positive and Negative Affect Schedule - Negative
time frame: Administered at baseline and after 10 days of light exposure
description: The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Negative is the sum of the 10 negative items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total negative score, a higher score indicates more negative affect. affect. Scores can range from 10-50 for Negative Affect.
measure: Karolinska Sleepiness Scale (KSS)
time frame: Administered at Baseline and after 10 Days of Light Exposure
description: The Karolinska Sleepiness Scale (KSS; Sleepiness Outcome) is a single-question with a 9-point Likert scale (1 = extremely alert, 9 = extremely sleepy, fighting sleep) measuring subjective sleepiness at the time of report.
measure: Makley Scale
time frame: A sleep log was completed every 2 hours during the night (2200 until 0600) on each patient by the unit nursing staff hours for 12 nights or until discharge from the hospital (2 nights baseline and after 10 nights of intervention light exposure)
description: The Makley scale is a 4-point ordinal scale which allows staff to score sleep as follows:
0 = asleep; 1 = drowsy/falling asleep; 2 = drowsy/waking up; 3 = awake.
measure: Functional Independence Measure (FIM) - Cognitive
time frame: Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)
description: Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35.
measure: Cooperation Measure (Therapy Outcome)
time frame: Collected at Baseline and after 10 days of light exposure
description: Cooperation Measure (Therapy Outcome). Patient cooperation was rated using a visual analogue scale (VAS) ranging from 0%-not cooperative to 100%- fully cooperative.10 Staff physical therapists were asked to rate cooperation both prior to initiation and after completion of phototherapy.
arm group label: Red Light (RL)
arm group type: Active Comparator
description: Intervention/Device:
This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.
arm group label: Bright White Light (BWL)
arm group type: Experimental
description: Intervention/Device:
This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms.
intervention type: Device
intervention name: Bright White Light (BWL)
description: The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.
arm group label: Bright White Light (BWL)
other name: Litebook® (Bright White Light)
intervention type: Device
intervention name: Red Light (RL)
description: The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.
arm group label: Red Light (RL)
other name: Litebook® (Red Light)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jeanne M Hoffman, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Jeanne Hoffman
investigator title: Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 