Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing

ADHD Clinical Trial

Official title:

Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036420
• Other study ID #: 22-000489
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Maya Tooker, B.S.
• Phone: (310) 825-2701
• Email: mtooker[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Device:
• 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

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Treatment Tolerability: Treatment Adherence	The number of days the participant was exposed to morning light therapy per self-report tracker.	7 weeks
Primary	Treatment Tolerability: Attrition	The number of participants who withdrew from the study out of the total cases enrolled.	7 weeks
Secondary	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).	7 weeks
Secondary	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).	7 weeks
Secondary	Treatment Sensitivity of Circadian Phase	Change in clock time of dim-light melatonin onset across baseline, mid-treatment, and post-treatment assessment timepoints.	7 weeks
Secondary	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.	7 weeks
Secondary	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.	7 weeks
Secondary	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).	7 weeks