ADHDNCT06036420
Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing
A study testing Flashed Light Therapy and Videoconference-delivered Cognitive Behavioral Therapy in people with ADHD, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Flashed Light Therapy and Videoconference-delivered Cognitive Behavioral Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of 14 to 17 years
- Current DSM-5 diagnosis of attention-deficit/hyperactivity disorder (any type)
- 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
Who cannot join
- 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 or 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)
Show all 14Show fewer
- Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication in the past month or planned use during the study
- Changes to any psychiatric medication within one month of study enrollment or planned changes 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 3 months of study enrollment or planned participation during the course of the study
- Use of light therapy within 6 months of study enrollment or planned use during the study
- Travel across > 2 time zones within one month of study enrollment 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
Los Angeles, California, 90095
About this study
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 and delayed sleep-wake schedules.
Read the 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.
- Conditions
- ADHD
- Being tested
- Flashed Light Therapy, Videoconference-delivered Cognitive Behavioral Therapy
- Keywords
- ADHD, light flashes, CBT, sleep
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, photopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flashed Light TherapyDevice
Also called Light flashes
Light flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds
Videoconference-delivered Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy | Experimental | 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. Receives: Device: Flashed Light Therapy; Behavioral: Videoconference-delivered Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 weeks
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).
Measured: 7 weeks
Treatment Tolerability: Treatment Adherence
The number of days the participant was exposed to morning light therapy per self-report tracker.
Measured: 7 weeks
Treatment Tolerability: Attrition
The number of participants who withdrew from the study out of the total cases enrolled.
Measured: 7 weeks
Secondary outcomes (6)
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).
Measured: 7 weeks
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).
Measured: 7 weeks
Treatment Sensitivity of Circadian Phase
Change in clock time of dim-light melatonin onset across baseline, mid-treatment, and post-treatment assessment timepoints.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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).
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start20 Oct 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily J. Ricketts, PhD, University of California, Los Angeles
- Investigators
- Emily J Ricketts, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036420
- Sponsor's protocol ID
- 22-000489
- Status last verified
- Feb 2026
- First submitted
- 17 May 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
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.
PubMed 31553469
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing
- ClinicalTrials.gov ID
- NCT06036420
- Acronym / sponsor ID
- 22-000489
- Conditions
- ADHD
- Keywords
- ADHD, light flashes, CBT, sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy | Experimental | Device: Flashed Light Therapy, Behavioral: Videoconference-delivered Cognitive Behavioral TherapyTreatment 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age of 14 to 17 years
- Current DSM-5 diagnosis of attention-deficit/hyperactivity disorder (any type)
- 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)
Key exclusion criteria (14 listed)
- 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 or higher
- Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep History Interview)
- Sleep solely in the prone position (i.e., on stomach)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flashed Light TherapyAlso: Light flashesLight flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds | Device | 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy |
| Videoconference-delivered Cognitive Behavioral TherapyTreatment 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. | Behavioural | 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy |
Primary outcome
Treatment Feasibility: Child-reported
Time frame: 7 weeks
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
Time frame: 7 weeks
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
Time frame: 7 weeks
The number of days the participant was exposed to morning light therapy per self-report tracker.
Treatment Tolerability: Attrition
Time frame: 7 weeks
The number of participants who withdrew from the study out of the total cases enrolled.
6 secondary outcomes
Assessment Tolerability: Child-reported
Time frame: 7 weeks
Assessment Tolerability: Parent-reported
Time frame: 7 weeks
Treatment Sensitivity of Circadian Phase
Time frame: 7 weeks
Treatment Sensitivity of Sleep Onset Time
Time frame: 7 weeks
Treatment Sensitivity of Sleep Duration
Time frame: 7 weeks
Treatment Sensitivity of Clinician-rated ADHD Severity (ADHD-RS-5)
Time frame: 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- BackgroundDuPaul, 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.
- Background: PubMed 31553469Kaplan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily J Ricketts, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flashed Light Therapy and Videoconference-delivered Cognitive Behavioral Therapy in people with ADHD, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Feasibility: Child-reported (time frame: 7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06036420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.