Identifying delayed sleep timing in children with ADHD
Official title: Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
Run by Duke University · NCT06971640 · Data updated 2026-11-12
We will test whether home sleep trackers plus a night lab melatonin test can find delayed circadian timing in 6–9-year-old children with ADHD and whether that sleep timing relates to their behavior and thinking.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 9 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | May 28, 2025 |
| Main results expected | November 2029 |
| Study ends | November 2029 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06971640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–9 with a primary DSM-5 diagnosis of ADHD, IQ > 80, generally healthy, and (if applicable) willing to pause melatonin during participation.
✕Probably not a fit
Children with psychosis, bipolar disorder, autism spectrum disorder, diagnosed occult sleep disorders (like sleep apnea), use of sleep medications other than melatonin, or plans to start stimulant medication during the study period are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project combines parent questionnaires, home wearable sensors, and a lab-based dim light melatonin onset (DLMO) assessment to characterize sleep and circadian timing in children with ADHD. Children ages 6–9 will wear an actigraphy-like device for seven days, use a skin temperature sensor overnight, and have mattress movement/heart-rate monitoring while parents complete daily sleep diaries. One evening visit includes a lab melatonin collection to pinpoint circadian timing, and cognitive and psychiatric assessments will measure attention and related symptoms. Investigators will analyze how circadian delay and sleep patterns relate to clinical heterogeneity and cognitive performance.
Why it matters
Potential benefit: If successful, this could help clinicians identify sleep-based biological markers to guide personalized sleep interventions that may improve attention and daytime functioning in children with ADHD.
How similar studies have gone: Prior studies have linked circadian delay to ADHD symptoms and used DLMO in older children and adolescents, but combining home wearables with lab-based melatonin timing in young children is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Child ages 6-9 2. Meet criteria for a primary psychiatric diagnosis of DSM-5 ADHD, any presentation 3. Intellectual functioning \>80 4. Healthy (i.e., no major medical problems) 5. If applicable, willingness to suspend use of melatonin during the study period Exclusion Criteria: 1. Meet DSM-5 criteria for psychosis, bipolar, or autism spectrum disorders 2. Diagnosis of occult sleep disorders, including sleep apnea or restless leg syndrome 3. Medication for sleep other than melatonin 4. Plans to initiate stimulant medication during the study period
Where it's running
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Duke University Medical Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Jessica Lunsford-Avery, Ph.D. — Duke University
- Study coordinator: Matt Gibson
- Email: matthew.gibson646@duke.edu
- Phone: 919-681-2521
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.