Back to resultsFlashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing
Primary Purpose
ADHD - Combined Type
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flashed Light Therapy
Videoconference-delivered Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for ADHD - Combined Type focused on measuring ADHD, light flashes, CBT, sleep
Eligibility Criteria
Inclusion Criteria: Age of 14 to 17 years Current DSM-5 diagnosis of ADHD-combined presentation Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime earlier and difficulty waking up early enough in the morning Evening chronotype (i.e., score ≤ 27 on the Morningness-Eveningness scale for Children) Clinically significant ADHD severity (ADHD-Rating Scale-5 score ≥ 24) Moderate global functioning impairment or worse (Clinical Global Impression-Severity scale score ≥ 4) Attending school (i.e., standard school year or summer school) during study enrollment Fluency in English Exclusion Criteria: Current or lifetime diagnosis of bipolar Disorder, psychosis, autism spectrum disorder, or pervasive developmental disorder Alcohol or substance dependence or suicidality within the past 6 months Current depression or anxiety in the severe range of higher Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep History Interview) Sleep solely in the prone position (i.e., on stomach) Full scale IQ ≤ 80 (Wechsler Abbreviated Scale for Intelligence-II) Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication in the past month or planned use during the study Use of any psychiatric medication within one month of study enrollment or planned use during the study Use of photosensitizing medication within one month of study enrollment or planned during the study Participation in behavior therapy for sleep and/or ADHD within the prior 3 months or planned participation during the course of the study Use of light therapy in the prior 6 months or planned use during the study Travel across > 2 time zones in the past month or planned travel outside of the time zone of participation during the study Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until late in the evening, early rising for sports practice) Medical or neurological condition (e.g., seizure disorder, chronic migraines) that would interfere in the individual's ability to participate
Sites / Locations
- Semel Institute for Neuroscience and Human Behavior, University of California, Los AngelesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy
Arm 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.
Outcomes
Primary Outcome Measures
Treatment Feasibility: Child-reported
Child rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
Treatment Feasibility: Parent-reported
Parent rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
Treatment Tolerability: Treatment Adherence
The number of days the participant was exposed to morning light therapy per self-report tracker.
Treatment Tolerability: Attrition
The number of participants who withdrew from the study out of the total cases enrolled.
Secondary Outcome Measures
Assessment Tolerability: Child-reported
Child rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
Assessment Tolerability: Parent-reported
Parent rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
Treatment Sensitivity of Circadian Phase
Change in clock time of dim-light melatonin onset across baseline, mid-treatment, and post-treatment assessment timepoints.
Treatment Sensitivity of Sleep Onset Time
Change in clock time of sleep onset across baseline, mid-treatment, and post-treatment assessment timepoints, as measured by actigraphy.
Treatment Sensitivity of Sleep Duration
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.
Treatment Sensitivity of Clinician-rated ADHD Severity (ADHD-RS-5)
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).
Full Information
NCT ID
NCT06036420
First Posted
May 17, 2023
Last Updated
September 6, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT06036420
Brief Title
Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing
Official Title
Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD - Combined Type
Keywords
ADHD, light flashes, CBT, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy
Arm Type
Experimental
Arm 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(s)
Flashed Light Therapy
Other Intervention Name(s)
Light flashes
Intervention Description
Light flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds
Intervention Type
Behavioral
Intervention Name(s)
Videoconference-delivered Cognitive Behavioral Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Treatment Feasibility: Child-reported
Description
Child rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
Time Frame
7 weeks
Title
Treatment Feasibility: Parent-reported
Description
Parent rating of how acceptable they find the treatment to be on a scale from 1 (very unacceptable) to 7 (very acceptable).
Time Frame
7 weeks
Title
Treatment Tolerability: Treatment Adherence
Description
The number of days the participant was exposed to morning light therapy per self-report tracker.
Time Frame
7 weeks
Title
Treatment Tolerability: Attrition
Description
The number of participants who withdrew from the study out of the total cases enrolled.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Assessment Tolerability: Child-reported
Description
Child rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
Time Frame
7 weeks
Title
Assessment Tolerability: Parent-reported
Description
Parent rating of how tolerable they find the study assessments to be on a scale from 1 (very intolerable) to 7 (very tolerable).
Time Frame
7 weeks
Title
Treatment Sensitivity of Circadian Phase
Description
Change in clock time of dim-light melatonin onset across baseline, mid-treatment, and post-treatment assessment timepoints.
Time Frame
7 weeks
Title
Treatment Sensitivity of Sleep Onset Time
Description
Change in clock time of sleep onset across baseline, mid-treatment, and post-treatment assessment timepoints, as measured by actigraphy.
Time Frame
7 weeks
Title
Treatment Sensitivity of Sleep Duration
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.
Time Frame
7 weeks
Title
Treatment Sensitivity of Clinician-rated ADHD Severity (ADHD-RS-5)
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).
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 14 to 17 years
Current DSM-5 diagnosis of ADHD-combined presentation
Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime earlier and difficulty waking up early enough in the morning
Evening chronotype (i.e., score ≤ 27 on the Morningness-Eveningness scale for Children)
Clinically significant ADHD severity (ADHD-Rating Scale-5 score ≥ 24)
Moderate global functioning impairment or worse (Clinical Global Impression-Severity scale score ≥ 4)
Attending school (i.e., standard school year or summer school) during study enrollment
Fluency in English
Exclusion Criteria:
Current or lifetime diagnosis of bipolar Disorder, psychosis, autism spectrum disorder, or pervasive developmental disorder
Alcohol or substance dependence or suicidality within the past 6 months
Current depression or anxiety in the severe range of higher
Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep History Interview)
Sleep solely in the prone position (i.e., on stomach)
Full scale IQ ≤ 80 (Wechsler Abbreviated Scale for Intelligence-II)
Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication in the past month or planned use during the study
Use of any psychiatric medication within one month of study enrollment or planned use during the study
Use of photosensitizing medication within one month of study enrollment or planned during the study
Participation in behavior therapy for sleep and/or ADHD within the prior 3 months or planned participation during the course of the study
Use of light therapy in the prior 6 months or planned use during the study
Travel across > 2 time zones in the past month or planned travel outside of the time zone of participation during the study
Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until late in the evening, early rising for sports practice)
Medical or neurological condition (e.g., seizure disorder, chronic migraines) that would interfere in the individual's ability to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Tooker, B.S.
Phone
(310) 825-2701
Email
mtooker@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily J Ricketts, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Tooker, B.S.
Phone
310-825-2701
Email
mtooker@mednet.ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
31553469
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.
Results Reference
background
Learn more about this trial
Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing
We'll reach out to this number within 24 hrs