Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing

NCT06036420 | Active Not Recruiting FDA Device

• 1 other identifier: 22-000489
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; light flashes; CBT; sleep

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  7 weeks

• Treatment Tolerability: Treatment Adherence

  The number of days the participant was exposed to morning light therapy per self-report tracker.

  7 weeks

• Treatment Tolerability: Attrition

  The number of participants who withdrew from the study out of the total cases enrolled.

  7 weeks

Secondary Outcomes (6)

• Assessment Tolerability: Child-reported

  7 weeks

• Assessment Tolerability: Parent-reported

  7 weeks

• Treatment Sensitivity of Circadian Phase

  7 weeks

• Treatment Sensitivity of Sleep Onset Time

  7 weeks

• Treatment Sensitivity of Sleep Duration

  7 weeks

Study Arms (1)

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.

Device: Flashed Light Therapy; Behavioral: Videoconference-delivered Cognitive Behavioral Therapy

Interventions

Flashed Light Therapy DEVICE

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

Also known as: Light flashes

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

Videoconference-delivered Cognitive Behavioral Therapy 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.

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

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

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

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  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.

  PMID: 31553469 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; photopsia

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Emily J Ricketts, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: September 13, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)