Status:
RECRUITING
Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
ADHD - Attention Deficit Disorder With Hyperactivity
ADHD
Eligibility:
All Genders
6-9 years
Brief Summary
The purpose of this study is to better understand sleep and circadian functioning in children with ADHD using home-based measures, parent report, and a lab based melatonin assessment. Investigators wi...
Detailed Description
Participants will be asked to review and sign a consent form to enroll. As part of the study, participants will: * Attend three study visits where they will be asked to complete questionnaires and as...
Eligibility Criteria
Inclusion
- Child ages 6-9
- Meet criteria for a primary psychiatric diagnosis of DSM-5 ADHD, any presentation
- Intellectual functioning \>80
- Healthy (i.e., no major medical problems)
- If applicable, willingness to suspend use of melatonin during the study period
Exclusion
- Meet DSM-5 criteria for psychosis, bipolar, or autism spectrum disorders
- Diagnosis of occult sleep disorders, including sleep apnea or restless leg syndrome
- Medication for sleep other than melatonin
- Plans to initiate stimulant medication during the study period
Key Trial Info
Start Date :
May 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06971640
Start Date
May 28 2025
End Date
November 1 2029
Last Update
October 9 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705