<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/NCT01700816</url>
  </required_header>
  <id_info>
    <org_study_id>2010P002801</org_study_id>
    <nct_id>NCT01700816</nct_id>
  </id_info>
  <brief_title>Prevention of Delirium After Bone Marrow Transplantation</brief_title>
  <official_title>Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if using bright light sessions during bone marrow&#xD;
      transplant can prevent people from developing confusion also known as delirium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot, double blind randomized study conducted in patients scheduled to undergo&#xD;
      bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to&#xD;
      look at the usefulness of bright light therapy in the prevention of delirium in a population&#xD;
      at high risk for developing this condition.&#xD;
&#xD;
      Delirium can develop in up to half of the people that undergo bone marrow transplant.&#xD;
      Symptoms include changes in level of alertness, confusion, and temporary problems with memory&#xD;
      and attention. In severe cases, it can be accompanied by agitation, paranoia(overly&#xD;
      suspicious), and hallucinations(seeing or hearing things that are not really there).&#xD;
&#xD;
      Bright light uses no medication and is often used to treat seasonal affective depression and&#xD;
      multiple sleep disorders. The light boxes are portable and are placed in front of individuals&#xD;
      for about 30 minutes every day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low incidence of delirium.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale</measure>
    <time_frame>From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant</time_frame>
    <description>Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)</measure>
    <time_frame>From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant</time_frame>
    <description>Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.&#xD;
10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.&#xD;
A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Dose of Antipsychotic Medications Required to Manage Delirium</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
    <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Creatinine and Blood Urea Nitrogen (BUN)</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
    <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red Blood Cells (RBC)</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
    <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White Blood Cells (WBC)</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
    <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin (HGB)</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
    <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit (HCT)</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
    <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet Count</measure>
    <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
    <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Bright light therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2500 Lux gaze directed every morning from 8 am until 8:30 am</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham light</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bright light therapy</intervention_name>
    <description>The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
    <arm_group_label>Bright light therapy</arm_group_label>
    <other_name>DL930 Day-Light Classic by Uplift Technologies Inc.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham light</intervention_name>
    <description>The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
    <arm_group_label>Sham light</arm_group_label>
    <other_name>DL930 Day-Light Classic Uplift Tecnologies placebo box</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 or older&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Patients scheduled to undergo HSCT&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of bipolar affective disorder&#xD;
&#xD;
          -  On-going delirium&#xD;
&#xD;
          -  History of substance abuse/dependence within 6 months prior to HSCT&#xD;
&#xD;
          -  History of invasive melanoma. Patients with a history of basal cell carcinoma,&#xD;
             melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s)&#xD;
             have been excised with negative margins&#xD;
&#xD;
          -  History of medical/dermatological conditions that make skin especially sensitive to&#xD;
             light,such as systemic lupus erythematosus (SLE) and/or porphyria&#xD;
&#xD;
          -  Eye condition that makes eyes vulnerable to light damage&#xD;
&#xD;
          -  Concomitant use of medications that increase sensitivity to sunlight, such as the&#xD;
             herbal supplement St. John's Wort&#xD;
&#xD;
          -  Established primary insomnia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Fernandez-Robles, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>October 27, 2016</results_first_submitted>
  <results_first_submitted_qc>May 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2017</results_first_posted>
  <last_update_submitted>May 26, 2017</last_update_submitted>
  <last_update_submitted_qc>May 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Carlos Fernandez-Robles</investigator_full_name>
    <investigator_title>Principal Investigator, MD</investigator_title>
  </responsible_party>
  <keyword>Delirium</keyword>
  <keyword>Hematopoietic stem cell transplantation</keyword>
  <keyword>Bone marrow transplantation</keyword>
  <keyword>Bright Light Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bright Light Therapy</title>
          <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
        </group>
        <group group_id="P2">
          <title>Sham Light</title>
          <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bright Light Therapy</title>
          <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
        </group>
        <group group_id="B2">
          <title>Sham Light</title>
          <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</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="21"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.3" spread="12.84"/>
                    <measurement group_id="B2" value="53.1" spread="14.15"/>
                    <measurement group_id="B3" value="53.2" spread="13.49"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Information not provided during interviews by all participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Non Hispanic White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <population>Information not provided during interviews by all participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Married/Partnered</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Single/Divorced/Widowed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest Education Level</title>
          <population>Information not provided during interviews by all participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>11th grade or less</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High School degree/GED</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some College</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Completed College</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale</title>
        <description>Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)</description>
        <time_frame>From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant</time_frame>
        <population>Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale</title>
          <description>Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)</description>
          <population>Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)</title>
        <description>Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.&#xD;
10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.&#xD;
A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium</description>
        <time_frame>From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant</time_frame>
        <population>Only one case of delirium developed, and only an MDAS score was collected for this participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)</title>
          <description>Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.&#xD;
10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.&#xD;
A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium</description>
          <population>Only one case of delirium developed, and only an MDAS score was collected for this participant.</population>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Dose of Antipsychotic Medications Required to Manage Delirium</title>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Antipsychotic Medications Required to Manage Delirium</title>
          <population>Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <population>One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="17" upper_limit="21"/>
                    <measurement group_id="O2" value="18.5" lower_limit="15" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)</title>
        <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).</description>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)</title>
          <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).</description>
          <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sodium (Na)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139" lower_limit="137" upper_limit="139"/>
                    <measurement group_id="O2" value="138.0" lower_limit="136.0" upper_limit="140.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (K)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="3.5" upper_limit="3.8"/>
                    <measurement group_id="O2" value="3.80" lower_limit="3.45" upper_limit="4.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride (Cl)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" lower_limit="103" upper_limit="105"/>
                    <measurement group_id="O2" value="103.0" lower_limit="102.0" upper_limit="106.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carbon Dioxide (CO2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.9" lower_limit="24.6" upper_limit="26.6"/>
                    <measurement group_id="O2" value="25.10" lower_limit="23.40" upper_limit="26.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Creatinine and Blood Urea Nitrogen (BUN)</title>
        <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Creatinine and Blood Urea Nitrogen (BUN)</title>
          <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
          <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
          <units>mg/dl</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serum Creatinine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" lower_limit="0.54" upper_limit="0.84"/>
                    <measurement group_id="O2" value="0.75" lower_limit="0.47" upper_limit="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen (BUN)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="6" upper_limit="12"/>
                    <measurement group_id="O2" value="8.5" lower_limit="4.5" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Red Blood Cells (RBC)</title>
        <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Red Blood Cells (RBC)</title>
          <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
          <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
          <units>M/uL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.21" lower_limit="2.88" upper_limit="3.31"/>
                    <measurement group_id="O2" value="2.93" lower_limit="2.80" upper_limit="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>White Blood Cells (WBC)</title>
        <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>White Blood Cells (WBC)</title>
          <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
          <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
          <units>K/uL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" lower_limit="2.10" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4.75" lower_limit="1.55" upper_limit="7.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin (HGB)</title>
        <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin (HGB)</title>
          <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
          <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
          <units>g/dl</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.70" lower_limit="8.90" upper_limit="10.20"/>
                    <measurement group_id="O2" value="9.55" lower_limit="8.85" upper_limit="9.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematocrit (HCT)</title>
        <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Hematocrit (HCT)</title>
          <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
          <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
          <units>volume percentage (vol%) of red blood ce</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.20" lower_limit="25.20" upper_limit="29.90"/>
                    <measurement group_id="O2" value="26.70" lower_limit="25.70" upper_limit="28.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Platelet Count</title>
        <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
        <time_frame>From admission to hospital to discharge, an expected average of 28 days post-transplant</time_frame>
        <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
        <group_list>
          <group group_id="O1">
            <title>Bright Light Therapy</title>
            <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
          <group group_id="O2">
            <title>Sham Light</title>
            <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
          </group>
        </group_list>
        <measure>
          <title>Platelet Count</title>
          <description>Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.</description>
          <population>8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group</population>
          <units>thousand cells/uL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" lower_limit="33" upper_limit="94"/>
                    <measurement group_id="O2" value="33.5" lower_limit="24.5" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days post-transplant or discharge, whichever comes first</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bright Light Therapy</title>
          <description>2500 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
        </group>
        <group group_id="E2">
          <title>Sham Light</title>
          <description>&lt;1000 Lux gaze directed every morning from 8 am until 8:30 am&#xD;
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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>Carlos Fernandez Robles MD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>6176432410</phone>
      <email>cfernandez-robles@mgh.harvard.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/NCT01700816
org study id: 2010P002801
nct id: NCT01700816
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to find out if using bright light sessions during bone marrow
      transplant can prevent people from developing confusion also known as delirium.
This is a pilot, double blind randomized study conducted in patients scheduled to undergo
      bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to
      look at the usefulness of bright light therapy in the prevention of delirium in a population
      at high risk for developing this condition.

      Delirium can develop in up to half of the people that undergo bone marrow transplant.
      Symptoms include changes in level of alertness, confusion, and temporary problems with memory
      and attention. In severe cases, it can be accompanied by agitation, paranoia(overly
      suspicious), and hallucinations(seeing or hearing things that are not really there).

      Bright light uses no medication and is often used to treat seasonal affective depression and
      multiple sleep disorders. The light boxes are portable and are placed in front of individuals
      for about 30 minutes every day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
time frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
description: Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
measure: Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
time frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant
description: Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.
10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.
A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium
measure: Average Dose of Antipsychotic Medications Required to Manage Delirium
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Hospital Length of Stay
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
description: Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
measure: Serum Creatinine and Blood Urea Nitrogen (BUN)
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
description: Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
measure: Red Blood Cells (RBC)
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
description: Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
measure: White Blood Cells (WBC)
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
description: Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
measure: Hemoglobin (HGB)
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
description: Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
measure: Hematocrit (HCT)
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
description: Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
measure: Platelet Count
time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
description: Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
arm group label: Bright light therapy
arm group type: Experimental
description: 2500 Lux gaze directed every morning from 8 am until 8:30 am
arm group label: Sham light
arm group type: Placebo Comparator
description: <1000 Lux gaze directed every morning from 8 am until 8:30 am
intervention type: Device
intervention name: Bright light therapy
description: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
arm group label: Bright light therapy
other name: DL930 Day-Light Classic by Uplift Technologies Inc.
intervention type: Device
intervention name: Sham light
description: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
arm group label: Sham light
other name: DL930 Day-Light Classic Uplift Tecnologies placebo box
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Carlos Fernandez-Robles, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Carlos Fernandez-Robles
investigator title: Principal Investigator, MD
mesh term: Delirium
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 