Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06971640

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

ADHD

Eligibility Criteria

Sex: All

Age: 6 - 9

Healthy Volunteers: Not accepted

Study Details

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 will also examine how sleep relates to psychiatric health and cognition among children with ADHD. The investigator for this study is Dr. Jessica Lunsford-Avery from the Department of Psychiatry.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

ADHD

Study ID

NCT06971640

Start date

May 28, 2025

Status verified date

May, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 9

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Circadian Rhythm (Sleep Timing) [ Time Frame: Nightly for 7 nights (at-home assessment) ]
  • DLMO - Dim Light Melatonin Onset [ Time Frame: Day 8 (second in-person study visit) ]

Central Contacts and Locations

Central contacts

Matt Gibson

919-681-2521matthew.gibson646@duke.edu

Jessica Lunsford-Avery, Ph.D.

jessica.r.avery@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Matt Gibson

919-681-2521matthew.gibson646@duke.edu

More Information

Sponsor

Duke University

Last update posted

May 5, 2026

Last verified

May, 2026

Keywords

  • ADHD
  • attention deficit disorder with hyperactivity
  • circadian rhythm
  • dim light melatonin onset

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-05.