Clinical trial NCT06971640: Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
Official title: Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ADHD - Attention Deficit Disorder With Hyperactivity
ADHD
Keywords: ADHD
attention deficit disorder with hyperactivity
circadian rhythm
dim light melatonin onset
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-05-14
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with ADHD ages 6-9 in the Duke University Health System

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.

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 assessments related to their child's attention and behavior, psychiatric health, and sleep habits. One of these visits is a lab-based melatonin assessment at night.
* Be asked to have their child wear a device (similar to a wrist watch) for a 7-day period. Parents will also be asked to complete an electronic daily diary about their child's sleep.
* Be asked to have their child wear a skin temperature sensor each evening after dinner until they wake up the next morning.
* Be asked to use a mattress sensor which measures movement, sleep state, and heart rate.

Participants will be compensated for their time.

Eligibility criteria: Inclusion Criteria:

* Ages 6-9
* Meets DSM-5 criteria for ADHD, any presentation
* IQ \> 80
* Healthy
* If applicable, willing to suspend melatonin usage during the study period

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Circadian Rhythm (Sleep Timing)
timeFrame: Nightly for 7 nights (at-home assessment)
measure: DLMO - Dim Light Melatonin Onset
timeFrame: Day 8 (second in-person study visit)
Secondary outcomes:
measure: Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Immediately following the study period (up to approximately 2 weeks)
measure: Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ)
timeFrame: Immediately following the study period (up to approximately 2 weeks)
measure: Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ)
timeFrame: Immediately following the study period (up to approximately 2 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jessica Lunsford-Avery, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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