<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/NCT01725750</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 12-1256</org_study_id>
    <secondary_id>HSM 12-00759</secondary_id>
    <secondary_id>H133A120084</secondary_id>
    <nct_id>NCT01725750</nct_id>
  </id_info>
  <brief_title>Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy</brief_title>
  <official_title>Treatment of Post-TBI Fatigue With Light Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</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 aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing&#xD;
      Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month&#xD;
      follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white&#xD;
      light treatment will report significant reductions in fatigue compared to individuals&#xD;
      receiving dim red light treatment for the same duration of time, and that these treatment&#xD;
      effects will be maintained one month after treatment completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the efficacy of bright white light exposure compared to dim red light exposure&#xD;
      in reducing post-TBI fatigue, an 8-week, randomized parallel-group clinical trial will be&#xD;
      performed. Outcome assessment will be blinded. Participants will complete a baseline battery&#xD;
      (T1) including 72 hours of actigraphy. Participants will then be randomized to either the&#xD;
      Bright White Light (BWL) or the Dim Red Light (DRL) group. After 4 weeks of daily, 30-minute&#xD;
      light treatments, the baseline battery will be re-administered (T2) along with 3 more days of&#xD;
      Actigraphy. A follow-up assessment involving the same measures will be administered 1&#xD;
      month-post cessation of light therapy (T3). Participant treatment allocations will be masked&#xD;
      for research team members conducting outcome measures. Secondary outcome measures will be&#xD;
      administered to explore the effects of light therapy on mood, daytime sleepiness, sleep&#xD;
      quality, circadian rhythms, anxiety, cognition and life satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Multidimensional Assessment of Fatigue (MAF)</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TBI-QOL Fatigue</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuro-QOL Depression and Sleep</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CNS Vital Signs TBI Rehab Toolbox</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Failures Questionnaire</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuro-QOL Anxiety</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actiwatch Spectrum - Acrophase</measure>
    <time_frame>4 weeks post treatment</time_frame>
    <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actiwatch Spectrum - Mesor</measure>
    <time_frame>4 weeks post treatment</time_frame>
    <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actiwatch Spectrum - F Statistic</measure>
    <time_frame>4 weeks post treatment</time_frame>
    <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Life Scale</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Satisfaction Questionnaire for Medication</measure>
    <time_frame>at 4 weeks (end-of-treatment)</time_frame>
    <description>An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Credibility/Expectancy Questionnaire</measure>
    <time_frame>at 4 weeks (end-of-treatment)</time_frame>
    <description>Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Bright White Light (BWL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dim Red Light (DRL)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bright White Light (BWL)</intervention_name>
    <description>Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</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>Dim Red Light (DRL)</intervention_name>
    <description>A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</description>
    <arm_group_label>Dim Red Light (DRL)</arm_group_label>
    <other_name>Litebook - Dim Red Light</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented TBI of any severity&#xD;
&#xD;
          -  At least 6 months post injury&#xD;
&#xD;
          -  Presence of clinically significant fatigue, operationalized as a score of 22 or more&#xD;
             on the Multidimensional Assessment of Fatigue&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological disease other than TBI&#xD;
&#xD;
          -  Pregnancy (because of pregnancy fatigue)&#xD;
&#xD;
          -  Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure,&#xD;
             cirrhosis or cancer treatment in the past year&#xD;
&#xD;
          -  Current major depressive episode or substance abuse&#xD;
&#xD;
          -  Diagnosed sleep disorder or high risk for sleep apnea&#xD;
&#xD;
          -  History of bipolar disorder or manic or hypomanic episodes&#xD;
&#xD;
          -  Current chronic, severe headaches&#xD;
&#xD;
          -  Sensitivity to bright light&#xD;
&#xD;
          -  History of retinal damage or disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne Gordon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsten Dams-O'Connor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <results_first_submitted>August 14, 2018</results_first_submitted>
  <results_first_submitted_qc>August 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 11, 2018</results_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Kristen Dams-O'Connor</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>TBI</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Post-TBI Fatigue</keyword>
  <keyword>PTBIF</keyword>
  <keyword>Depressed Mood</keyword>
  <keyword>Excessive Daytime Sleepiness</keyword>
  <keyword>Circadian Rhythm</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Cognitive Dysfunction</keyword>
  <keyword>Intervention</keyword>
  <keyword>Treatment</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>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <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>March 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT01725750/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From October 2015-January 2017, recruitment materials were sent to previous research and support group participants, and other local TBI centers. Information was also posted online and at consumer conferences. External sites included Centre for Neuro Skills facilities and post-acute rehab centers in Bakersfield and Los Angeles, CA, and Dallas, TX.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Bright White Light (BWL)</title>
          <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
        </group>
        <group group_id="P2">
          <title>Dim Red Light (DRL)</title>
          <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bright White Light (BWL)</title>
          <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
        </group>
        <group group_id="B2">
          <title>Dim Red Light (DRL)</title>
          <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</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="44"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="88"/>
          </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="48.045" spread="16.335"/>
                    <measurement group_id="B2" value="45.182" spread="13.138"/>
                    <measurement group_id="B3" value="46.614" spread="14.808"/>
                  </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="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="44"/>
                  </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>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race/Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of education completed</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.841" spread="2.533"/>
                    <measurement group_id="B2" value="15.651" spread="2.654"/>
                    <measurement group_id="B3" value="15.747" spread="2.580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Multidimensional Assessment of Fatigue (MAF)</title>
        <description>Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Multidimensional Assessment of Fatigue (MAF)</title>
          <description>Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.</description>
          <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="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.332" spread="9.043"/>
                    <measurement group_id="O2" value="30.531" spread="10.633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.993" spread="9.993"/>
                    <measurement group_id="O2" value="24.937" spread="10.558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.658" spread="12.213"/>
                    <measurement group_id="O2" value="25.350" spread="10.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TBI-QOL Fatigue</title>
        <description>The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>TBI-QOL Fatigue</title>
          <description>The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.</description>
          <units>T score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.819" spread="6.255"/>
                    <measurement group_id="O2" value="58.821" spread="7.533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.071" spread="7.384"/>
                    <measurement group_id="O2" value="55.724" spread="8.305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.226" spread="8.481"/>
                    <measurement group_id="O2" value="57.252" spread="9.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuro-QOL Depression and Sleep</title>
        <description>The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuro-QOL Depression and Sleep</title>
          <description>The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.893" spread="8.033"/>
                    <measurement group_id="O2" value="82.942" spread="7.570"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.337" spread="8.190"/>
                    <measurement group_id="O2" value="52.864" spread="7.896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.162" spread="8.193"/>
                    <measurement group_id="O2" value="52.290" spread="9.698"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Epworth Sleepiness Scale (ESS)</title>
        <description>The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Epworth Sleepiness Scale (ESS)</title>
          <description>The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.</description>
          <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="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.695" spread="4.869"/>
                    <measurement group_id="O2" value="6.970" spread="4.323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.162" spread="3.927"/>
                    <measurement group_id="O2" value="8.312" spread="3.182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.169" spread="4.041"/>
                    <measurement group_id="O2" value="8.133" spread="3.899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CNS Vital Signs TBI Rehab Toolbox</title>
        <description>The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>CNS Vital Signs TBI Rehab Toolbox</title>
          <description>The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.</description>
          <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="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.59" spread="26.260"/>
                    <measurement group_id="O2" value="82.83" spread="21.805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.19" spread="27.489"/>
                    <measurement group_id="O2" value="77.64" spread="37.658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.17" spread="28.051"/>
                    <measurement group_id="O2" value="79.10" spread="35.443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Failures Questionnaire</title>
        <description>The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Failures Questionnaire</title>
          <description>The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.</description>
          <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="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.823" spread="16.872"/>
                    <measurement group_id="O2" value="42.806" spread="15.175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.261" spread="17.590"/>
                    <measurement group_id="O2" value="46.564" spread="16.646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.503" spread="18.204"/>
                    <measurement group_id="O2" value="45.352" spread="18.310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuro-QOL Anxiety</title>
        <description>The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuro-QOL Anxiety</title>
          <description>The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.</description>
          <units>T score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.725" spread="8.137"/>
                    <measurement group_id="O2" value="56.253" spread="7.581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.250" spread="8.929"/>
                    <measurement group_id="O2" value="56.661" spread="7.766"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.441" spread="8.073"/>
                    <measurement group_id="O2" value="55.226" spread="8.828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Actiwatch Spectrum - Acrophase</title>
        <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs.</description>
        <time_frame>4 weeks post treatment</time_frame>
        <population>After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.&#xD;
Bright White Light (BWL): Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.&#xD;
Dim Red Light (DRL): A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</description>
          </group>
        </group_list>
        <measure>
          <title>Actiwatch Spectrum - Acrophase</title>
          <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs.</description>
          <population>After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.68" spread="2.29"/>
                    <measurement group_id="O2" value="15.98" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Actiwatch Spectrum - Mesor</title>
        <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern.</description>
        <time_frame>4 weeks post treatment</time_frame>
        <population>After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.&#xD;
Bright White Light (BWL): Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.&#xD;
Dim Red Light (DRL): A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</description>
          </group>
        </group_list>
        <measure>
          <title>Actiwatch Spectrum - Mesor</title>
          <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern.</description>
          <population>After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.</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="30"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="0.21"/>
                    <measurement group_id="O2" value="0.83" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Actiwatch Spectrum - F Statistic</title>
        <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern.</description>
        <time_frame>4 weeks post treatment</time_frame>
        <population>After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and in the 23 red arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.&#xD;
Bright White Light (BWL): Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.&#xD;
Dim Red Light (DRL): A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18&quot; from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.</description>
          </group>
        </group_list>
        <measure>
          <title>Actiwatch Spectrum - F Statistic</title>
          <description>Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.&#xD;
F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern.</description>
          <population>After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and in the 23 red arm.</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="30"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1765.36" spread="1120.32"/>
                    <measurement group_id="O2" value="2307.38" spread="1574.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Life Scale</title>
        <description>Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.</description>
        <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Life Scale</title>
          <description>Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.</description>
          <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="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.409" spread="6.956"/>
                    <measurement group_id="O2" value="18.698" spread="7.386"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (end of treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.622" spread="7.154"/>
                    <measurement group_id="O2" value="18.394" spread="7.925"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks (one month post treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.441" spread="6.219"/>
                    <measurement group_id="O2" value="19.900" spread="6.707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Satisfaction Questionnaire for Medication</title>
        <description>An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.</description>
        <time_frame>at 4 weeks (end-of-treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction Questionnaire for Medication</title>
          <description>An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.455" spread="29.827"/>
                    <measurement group_id="O2" value="47.546" spread="33.112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Credibility/Expectancy Questionnaire</title>
        <description>Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.</description>
        <time_frame>at 4 weeks (end-of-treatment)</time_frame>
        <population>Compared to other outcome measures, fewer CEQ records were analyzed due to participant non-compliance.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright White Light (BWL)</title>
            <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
          </group>
          <group group_id="O2">
            <title>Dim Red Light (DRL)</title>
            <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</description>
          </group>
        </group_list>
        <measure>
          <title>Credibility/Expectancy Questionnaire</title>
          <description>Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.</description>
          <population>Compared to other outcome measures, fewer CEQ records were analyzed due to participant non-compliance.</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="43"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.5539" spread="2.577"/>
                    <measurement group_id="O2" value=".4489" spread="2.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bright White Light (BWL)</title>
          <description>Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6&quot; x 5&quot; x 1&quot;) and lightweight (8 oz.) box.</description>
        </group>
        <group group_id="E2">
          <title>Dim Red Light (DRL)</title>
          <description>Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.</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="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Jacob Greisman</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>212-241-4886</phone>
      <email>Jacob.greisman@mountsinai.org</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/NCT01725750
org study id: GCO 12-1256
secondary id: HSM 12-00759
secondary id: H133A120084
nct id: NCT01725750
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing
      Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month
      follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white
      light treatment will report significant reductions in fatigue compared to individuals
      receiving dim red light treatment for the same duration of time, and that these treatment
      effects will be maintained one month after treatment completion.
To determine the efficacy of bright white light exposure compared to dim red light exposure
      in reducing post-TBI fatigue, an 8-week, randomized parallel-group clinical trial will be
      performed. Outcome assessment will be blinded. Participants will complete a baseline battery
      (T1) including 72 hours of actigraphy. Participants will then be randomized to either the
      Bright White Light (BWL) or the Dim Red Light (DRL) group. After 4 weeks of daily, 30-minute
      light treatments, the baseline battery will be re-administered (T2) along with 3 more days of
      Actigraphy. A follow-up assessment involving the same measures will be administered 1
      month-post cessation of light therapy (T3). Participant treatment allocations will be masked
      for research team members conducting outcome measures. Secondary outcome measures will be
      administered to explore the effects of light therapy on mood, daytime sleepiness, sleep
      quality, circadian rhythms, anxiety, cognition and life satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Multidimensional Assessment of Fatigue (MAF)
time frame: baseline, 4 weeks, 8 weeks
description: Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.
measure: TBI-QOL Fatigue
time frame: baseline, 4 weeks, 8 weeks
description: The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.
measure: Neuro-QOL Depression and Sleep
time frame: baseline, 4 weeks, 8 weeks
description: The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.
measure: Epworth Sleepiness Scale (ESS)
time frame: baseline, 4 weeks, 8 weeks
description: The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.
measure: CNS Vital Signs TBI Rehab Toolbox
time frame: baseline, 4 weeks, 8 weeks
description: The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.
measure: Cognitive Failures Questionnaire
time frame: baseline, 4 weeks, 8 weeks
description: The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.
measure: Neuro-QOL Anxiety
time frame: baseline, 4 weeks, 8 weeks
description: The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.
measure: Actiwatch Spectrum - Acrophase
time frame: 4 weeks post treatment
description: Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.
Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs.
measure: Actiwatch Spectrum - Mesor
time frame: 4 weeks post treatment
description: Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.
Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern.
measure: Actiwatch Spectrum - F Statistic
time frame: 4 weeks post treatment
description: Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.
F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern.
measure: Satisfaction With Life Scale
time frame: baseline, 4 weeks, 8 weeks
description: Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.
measure: Treatment Satisfaction Questionnaire for Medication
time frame: at 4 weeks (end-of-treatment)
description: An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.
measure: Credibility/Expectancy Questionnaire
time frame: at 4 weeks (end-of-treatment)
description: Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.
arm group label: Bright White Light (BWL)
arm group type: Experimental
description: Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.
arm group label: Dim Red Light (DRL)
arm group type: Active Comparator
description: Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
intervention type: Device
intervention name: Bright White Light (BWL)
description: Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.
arm group label: Bright White Light (BWL)
other name: Litebook - Bright White Light
intervention type: Device
intervention name: Dim Red Light (DRL)
description: A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.
arm group label: Dim Red Light (DRL)
other name: Litebook - Dim Red Light
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wayne Gordon, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Kirsten Dams-O'Connor, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Kristen Dams-O'Connor
investigator title: Associate Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Fatigue
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 