Identifying delayed sleep timing in children with ADHD
Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
Duke University · NCT06971640
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 6 Years to 9 Years |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06971640 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ADHD - Attention Deficit Disorder With Hyperactivity, ADHD, attention deficit disorder with hyperactivity, circadian rhythm, dim light melatonin onset