xml: <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/NCT06036420</url>
    </required_header>
    <id_info>
      <org_study_id>22-000489</org_study_id>
      <nct_id>NCT06036420</nct_id>
    </id_info>
    <brief_title>Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing</brief_title>
    <official_title>Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Los Angeles</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>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary aim of the present research project is to examine the feasibility, as measured by&#xD;
        treatment perceptions, and tolerability, as measured by adherence and attrition, of two weeks&#xD;
        of flashed light therapy alone followed by four weeks of daily flashed light therapy combined&#xD;
        with four weekly videoconference-delivered cognitive behavioral therapy sessions targeting&#xD;
        circadian rhythms and sleep in four adolescents aged 14 to 17 years with&#xD;
        attention-deficit/hyperactivity disorder-combined type and delayed sleep-wake schedules.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participation in this research will last about 7 weeks. Participation will involve an initial&#xD;
        screening visit lasting 3 hours to assess eligibility. This visit will involve interviews and&#xD;
        tasks to assess for psychiatric diagnosis, sleep history, ADHD severity, and thought&#xD;
        patterns. Participants and parents will also complete questionnaires assessing&#xD;
        parent-reported and self-reported ADHD severity, personal and family demographics, and&#xD;
        medical and psychiatric history. Following this visit, participants will be asked to monitor&#xD;
        their sleep for 7 nights using a sleep watch and sleep diary, and provide daily report of&#xD;
        bedtimes and risetimes via text message.&#xD;
  &#xD;
        After sleep monitoring, an 8-hour baseline assessment visit involving interviews,&#xD;
        questionnaires, and saliva sampling will be scheduled from 7 hours before average habitual&#xD;
        bedtime up until average bedtime to assess the internal body clock. The morning following the&#xD;
        baseline assessment, light therapy will begin and continue daily for two weeks. During the&#xD;
        two-week period, participants will monitor sleep nightly using a sleep watch and sleep diary.&#xD;
  &#xD;
        Following termination of the two-week course of flashed light therapy, participants will&#xD;
        complete an 8-hour mid-treatment assessment involving interviews, questionnaires, and saliva&#xD;
        sampling, as described above. Following this assessment, participants will begin weekly&#xD;
        50-minute individual videoconference-delivered cognitive behavioral therapy while continuing&#xD;
        to use the flashed light therapy device and monitor sleep (via sleep diary, watch, and sleep&#xD;
        location verification) for a duration of four weeks. Following treatment, participants will&#xD;
        have a post-treatment 8-hour assessment, again involving interviews, questionnaires, and a&#xD;
        salivary assessment of the internal body clock, as described above.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment Feasibility: Child-reported</measure>
      <time_frame>7 weeks</time_frame>
      <description>Child rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Feasibility: Parent-reported</measure>
      <time_frame>7 weeks</time_frame>
      <description>Parent rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Tolerability: Treatment Adherence</measure>
      <time_frame>7 weeks</time_frame>
      <description>The number of days the participant was exposed to morning light therapy per self-report tracker.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Tolerability: Attrition</measure>
      <time_frame>7 weeks</time_frame>
      <description>The number of participants who withdrew from the study out of the total cases enrolled.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment Tolerability: Child-reported</measure>
      <time_frame>7 weeks</time_frame>
      <description>Child rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment Tolerability: Parent-reported</measure>
      <time_frame>7 weeks</time_frame>
      <description>Parent rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Sensitivity of Circadian Phase</measure>
      <time_frame>7 weeks</time_frame>
      <description>Change in clock time of dim-light melatonin onset across baseline, mid-treatment, and post-treatment assessment timepoints.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Sensitivity of Sleep Onset Time</measure>
      <time_frame>7 weeks</time_frame>
      <description>Change in clock time of sleep onset across baseline, mid-treatment, and post-treatment assessment timepoints, as measured by actigraphy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Sensitivity of Sleep Duration</measure>
      <time_frame>7 weeks</time_frame>
      <description>Change in total sleep time (total number of minutes spent asleep during the sleep episode) across baseline, mid-treatment, and post-treatment, as measured by actigraphy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Sensitivity of Clinician-rated ADHD Severity (ADHD-RS-5)</measure>
      <time_frame>7 weeks</time_frame>
      <description>Change in clinician rated ADHD Rating Scale-5 (ADHD-RS-5) total score across baseline, mid-treatment, and post-treatment assessment timepoints. The ADHD-RS-5 is an 18-item clinical rated scale assessing ADHD symptoms and the extent to which these symptoms exact impairment (DuPaul et al., 2016). Clinicans rate symptom severity and impairment on a scale ranging from 0 (none) to 3 (severe).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">4</enrollment>
    <condition>ADHD - Combined Type</condition>
    <arm_group>
      <arm_group_label>1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment Phase 1 (2 weeks duration): light flashes administered for 60 minutes daily beginning 75 minutes prior to the participant's average morning wake time and ending 15 minutes before average morning wake time.&#xD;
  Treatment Phase 2 (4 weeks duration): will begin immediately following phase 1 and involve daily light flashes (as described above) combined with weekly 50-minute videoconference-delivered cognitive-behavioral therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Flashed Light Therapy</intervention_name>
      <description>Light flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds</description>
      <arm_group_label>1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy</arm_group_label>
      <other_name>Light flashes</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Videoconference-delivered Cognitive Behavioral Therapy</intervention_name>
      <description>Treatment will involve psychoeducation on sleep, circadian rhythms and light exposure, motivational interviewing, advancing of bedtime schedule, time management and coping with poor sleep, sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring for worry.</description>
      <arm_group_label>1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age of 14 to 17 years&#xD;
  &#xD;
            2. Current DSM-5 diagnosis of ADHD-combined presentation&#xD;
  &#xD;
            3. Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime&#xD;
               earlier and difficulty waking up early enough in the morning&#xD;
  &#xD;
            4. Evening chronotype (i.e., score ≤ 27 on the Morningness-Eveningness scale for&#xD;
               Children)&#xD;
  &#xD;
            5. Clinically significant ADHD severity (ADHD-Rating Scale-5 score ≥ 24)&#xD;
  &#xD;
            6. Moderate global functioning impairment or worse (Clinical Global Impression-Severity&#xD;
               scale score ≥ 4)&#xD;
  &#xD;
            7. Attending school (i.e., standard school year or summer school) during study enrollment&#xD;
  &#xD;
            8. Fluency in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Current or lifetime diagnosis of bipolar Disorder, psychosis, autism spectrum&#xD;
               disorder, or pervasive developmental disorder&#xD;
  &#xD;
            2. Alcohol or substance dependence or suicidality within the past 6 months&#xD;
  &#xD;
            3. Current depression or anxiety in the severe range of higher&#xD;
  &#xD;
            4. Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep&#xD;
               History Interview)&#xD;
  &#xD;
            5. Sleep solely in the prone position (i.e., on stomach)&#xD;
  &#xD;
            6. Full scale IQ ≤ 80 (Wechsler Abbreviated Scale for Intelligence-II)&#xD;
  &#xD;
            7. Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication&#xD;
               in the past month or planned use during the study&#xD;
  &#xD;
            8. Use of any psychiatric medication within one month of study enrollment or planned use&#xD;
               during the study&#xD;
  &#xD;
            9. Use of photosensitizing medication within one month of study enrollment or planned&#xD;
               during the study&#xD;
  &#xD;
           10. Participation in behavior therapy for sleep and/or ADHD within the prior 3 months or&#xD;
               planned participation during the course of the study&#xD;
  &#xD;
           11. Use of light therapy in the prior 6 months or planned use during the study&#xD;
  &#xD;
           12. Travel across &gt; 2 time zones in the past month or planned travel outside of the time&#xD;
               zone of participation during the study&#xD;
  &#xD;
           13. Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until&#xD;
               late in the evening, early rising for sports practice)&#xD;
  &#xD;
           14. Medical or neurological condition (e.g., seizure disorder, chronic migraines) that&#xD;
               would interfere in the individual's ability to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emily J Ricketts, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Los Angeles</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maya Tooker, B.S.</last_name>
      <phone>(310) 825-2701</phone>
      <email>mtooker@mednet.ucla.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90095</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maya Tooker, B.S.</last_name>
        <phone>310-825-2701</phone>
        <email>mtooker@mednet.ucla.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>DuPaul, G. J., Power, T. J., Anastopoulos, A. D., &amp; Reid, R. (2016). ADHD Rating Scale-5 for children and adolescents: Checklists, norms, and clinical interpretation. The Guilford Press.</citation>
    </reference>
    <reference>
      <citation>Kaplan KA, Mashash M, Williams R, Batchelder H, Starr-Glass L, Zeitzer JM. Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911944. doi: 10.1001/jamanetworkopen.2019.11944.</citation>
      <PMID>31553469</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Emily J. Ricketts, PhD</investigator_full_name>
      <investigator_title>Assistant Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>ADHD</keyword>
    <keyword>light flashes</keyword>
    <keyword>CBT</keyword>
    <keyword>sleep</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036420
  org study id: 22-000489
  nct id: NCT06036420
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The primary aim of the present research project is to examine the feasibility, as measured by
        treatment perceptions, and tolerability, as measured by adherence and attrition, of two weeks
        of flashed light therapy alone followed by four weeks of daily flashed light therapy combined
        with four weekly videoconference-delivered cognitive behavioral therapy sessions targeting
        circadian rhythms and sleep in four adolescents aged 14 to 17 years with
        attention-deficit/hyperactivity disorder-combined type and delayed sleep-wake schedules.
  Participation in this research will last about 7 weeks. Participation will involve an initial
        screening visit lasting 3 hours to assess eligibility. This visit will involve interviews and
        tasks to assess for psychiatric diagnosis, sleep history, ADHD severity, and thought
        patterns. Participants and parents will also complete questionnaires assessing
        parent-reported and self-reported ADHD severity, personal and family demographics, and
        medical and psychiatric history. Following this visit, participants will be asked to monitor
        their sleep for 7 nights using a sleep watch and sleep diary, and provide daily report of
        bedtimes and risetimes via text message.
  
        After sleep monitoring, an 8-hour baseline assessment visit involving interviews,
        questionnaires, and saliva sampling will be scheduled from 7 hours before average habitual
        bedtime up until average bedtime to assess the internal body clock. The morning following the
        baseline assessment, light therapy will begin and continue daily for two weeks. During the
        two-week period, participants will monitor sleep nightly using a sleep watch and sleep diary.
  
        Following termination of the two-week course of flashed light therapy, participants will
        complete an 8-hour mid-treatment assessment involving interviews, questionnaires, and saliva
        sampling, as described above. Following this assessment, participants will begin weekly
        50-minute individual videoconference-delivered cognitive behavioral therapy while continuing
        to use the flashed light therapy device and monitor sleep (via sleep diary, watch, and sleep
        location verification) for a duration of four weeks. Following treatment, participants will
        have a post-treatment 8-hour assessment, again involving interviews, questionnaires, and a
        salivary assessment of the internal body clock, as described above.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Treatment Feasibility: Child-reported
  time frame: 7 weeks
  description: Child rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
  measure: Treatment Feasibility: Parent-reported
  time frame: 7 weeks
  description: Parent rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
  measure: Treatment Tolerability: Treatment Adherence
  time frame: 7 weeks
  description: The number of days the participant was exposed to morning light therapy per self-report tracker.
  measure: Treatment Tolerability: Attrition
  time frame: 7 weeks
  description: The number of participants who withdrew from the study out of the total cases enrolled.
  measure: Assessment Tolerability: Child-reported
  time frame: 7 weeks
  description: Child rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
  measure: Assessment Tolerability: Parent-reported
  time frame: 7 weeks
  description: Parent rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
  measure: Treatment Sensitivity of Circadian Phase
  time frame: 7 weeks
  description: Change in clock time of dim-light melatonin onset across baseline, mid-treatment, and post-treatment assessment timepoints.
  measure: Treatment Sensitivity of Sleep Onset Time
  time frame: 7 weeks
  description: Change in clock time of sleep onset across baseline, mid-treatment, and post-treatment assessment timepoints, as measured by actigraphy.
  measure: Treatment Sensitivity of Sleep Duration
  time frame: 7 weeks
  description: Change in total sleep time (total number of minutes spent asleep during the sleep episode) across baseline, mid-treatment, and post-treatment, as measured by actigraphy.
  measure: Treatment Sensitivity of Clinician-rated ADHD Severity (ADHD-RS-5)
  time frame: 7 weeks
  description: Change in clinician rated ADHD Rating Scale-5 (ADHD-RS-5) total score across baseline, mid-treatment, and post-treatment assessment timepoints. The ADHD-RS-5 is an 18-item clinical rated scale assessing ADHD symptoms and the extent to which these symptoms exact impairment (DuPaul et al., 2016). Clinicans rate symptom severity and impairment on a scale ranging from 0 (none) to 3 (severe).
  arm group label: 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy
  arm group type: Experimental
  description: Treatment Phase 1 (2 weeks duration): light flashes administered for 60 minutes daily beginning 75 minutes prior to the participant's average morning wake time and ending 15 minutes before average morning wake time.
  Treatment Phase 2 (4 weeks duration): will begin immediately following phase 1 and involve daily light flashes (as described above) combined with weekly 50-minute videoconference-delivered cognitive-behavioral therapy.
  intervention type: Device
  intervention name: Flashed Light Therapy
  description: Light flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds
  arm group label: 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy
  other name: Light flashes
  intervention type: Behavioral
  intervention name: Videoconference-delivered Cognitive Behavioral Therapy
  description: Treatment will involve psychoeducation on sleep, circadian rhythms and light exposure, motivational interviewing, advancing of bedtime schedule, time management and coping with poor sleep, sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring for worry.
  arm group label: 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Emily J Ricketts, Ph.D.
  role: Principal Investigator
  affiliation: University of California, Los Angeles
  last name: Maya Tooker, B.S.
  phone: (310) 825-2701
  email: mtooker@mednet.ucla.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: DuPaul, G. J., Power, T. J., Anastopoulos, A. D., & Reid, R. (2016). ADHD Rating Scale-5 for children and adolescents: Checklists, norms, and clinical interpretation. The Guilford Press.
  citation: Kaplan KA, Mashash M, Williams R, Batchelder H, Starr-Glass L, Zeitzer JM. Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911944. doi: 10.1001/jamanetworkopen.2019.11944.
  PMID: 31553469
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Emily J. Ricketts, PhD
  investigator title: Assistant Clinical Professor
  mesh term: Attention Deficit Disorder with Hyperactivity
  sharing ipd: No