Flashed Light Therapy for Adolescents with ADHD and Delayed Sleep Timing

NCT ID: NCT06036420

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-06-20

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 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.

Conditions

ADHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy

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.

Group Type: EXPERIMENTAL

Flashed Light Therapy

Intervention Type: DEVICE

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 Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Flashed Light Therapy

Light flashes will be presented over 60 minutes as 3-millilisecond flashes of white light at 4,000 lux every 20 seconds

Intervention Type: DEVICE

Videoconference-delivered Cognitive Behavioral Therapy

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Light flashes

Eligibility Criteria

Inclusion Criteria

1. Age of 14 to 17 years

2. Current DSM-5 diagnosis of attention-deficit/hyperactivity disorder (any type)

3. Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime earlier and difficulty waking up early enough in the morning

4. Evening chronotype (i.e., score ≤ 27 on the Morningness-Eveningness scale for Children)

5. Clinically significant ADHD severity (ADHD-Rating Scale-5 score ≥ 24)

6. Moderate global functioning impairment or worse (Clinical Global Impression-Severity scale score ≥ 4)

7. Attending school (i.e., standard school year or summer school) during study enrollment

8. Fluency in English

Exclusion Criteria

1. Current or lifetime diagnosis of bipolar Disorder, psychosis, autism spectrum disorder, or pervasive developmental disorder

2. Alcohol or substance dependence or suicidality within the past 6 months

3. Current depression or anxiety in the severe range or higher

4. Sleep disorder present besides delayed sleep-wake phase disorder (Clinical Sleep History Interview)

5. Sleep solely in the prone position (i.e., on stomach)

6. Full scale IQ ≤ 80 (Wechsler Abbreviated Scale for Intelligence-II)

7. Use of any over-the-counter (e.g., melatonin, Benadryl) or prescribed sleep medication in the past month or planned use during the study

8. Changes to any psychiatric medication within one month of study enrollment or planned changes during the study

9. Use of photosensitizing medication within one month of study enrollment or planned during the study

10. Participation in behavior therapy for sleep and/or ADHD within 3 months of study enrollment or planned participation during the course of the study

11. Use of light therapy within 6 months of study enrollment or planned use during the study

12. Travel across > 2 time zones within one month of study enrollment or planned travel outside of the time zone of participation during the study

13. Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until late in the evening, early rising for sports practice)

14. Medical or neurological condition (e.g., seizure disorder, chronic migraines) that would interfere in the individual's ability to participate

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Emily J. Ricketts, PhD

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily J Ricketts, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maya Tooker, B.S.

Role: CONTACT

mtooker@mednet.ucla.edu

(310) 825-2701

Facility Contacts

Maya Tooker, B.S.

Role: primary

mtooker@mednet.ucla.edu

(310) 825-2701

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 31553469 (View on PubMed)

Other Identifiers

22-000489

Identifier Type: -

Identifier Source: org_study_id