Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
- Conditions
- ADHD - Attention Deficit Disorder With HyperactivityPsychiatric DisordersADHD
- Registration Number
- NCT06971640
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to better understand sleep and circadian functioning in children with Attention Deficit/Hyperactivity Disorder (ADHD) using home-based measures, parent report, and a lab-based melatonin assessment. The investigators will also examine how sleep relates to psychiatric health and cognition among children with ADHD.
This study aims to improve how we assess circadian rhythms in children with ADHD, particularly those between the ages of 6 and 9, the typical age for an ADHD diagnosis. By combining lab-based tests and home assessments, the research will better understand how circadian delays affect ADHD symptoms and cognitive functioning. The goal is to develop personalized sleep treatments that can improve the health and functioning of children with ADHD.
The study will focus on 250 children with ADHD in the 6-9 age range. Researchers will use standard sleep measurements and a gold-standard test (DLMO - Dim Light Melatonin Onset) to establish the prevalence of delayed circadian rhythms and consider the unique clinical outcomes associated with circadian dysfunction. Additionally, the study will explore whether wearable sensors can be a simpler, less intrusive way to identify biologically based sleep problems in children with ADHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- Parent/caregiver must have ability to speak, read, and write in English
- Parent/caregiver must have ability to follow written and verbal instructions
- Parent/caregiver must have ability and willingness to comply with study procedures.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Circadian Rhythm (Sleep Timing) Nightly for 7 nights (at-home assessment) Wearable sensor data collection includes 3 sensors and supporting materials. The GreenTEG Core sensor will measure changes in core body temperature (CBT) beginning each evening and continuing through the night until morning waking. The Withings Mat will index times in/out of bed and related sleep metrics. The Fitbit Inspire 3 will continuously measure movement and heart rate.
DLMO - Dim Light Melatonin Onset Day 8 (every 30 min for a period beginning 5 hours before the child's average weeknight bedtime and extending to 1 hour after their average weeknight bedtime) Salivary melatonin will be collected during an in-lab assessment, occurring on Friday night following the home assessment. Twelve saliva samples (\~2ml) will be collected in a darkened environment every 30 min for a period beginning 5 hours before the child's average weeknight bedtime and extending to 1 hour after their average weeknight bedtime as verified by the previous week's sleep diary. The time at which salivary melatonin concentrations exceed 4 pg/mL will be used for determining DLMO. Circadian alignment will be measured via phase angle calculation, or the duration of time between DLMO and average bedtime as recorded by (1) sleep diary and (2) average sleep onset (actigraphy).
- Secondary Outcome Measures
Name Time Method Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ) Immediately following the study period (up to approximately 2 weeks) Total score is the sum of all the scored questions on the CSHQ. The score ranges from 33 to 99, where a score above 41 indicates a pediatric sleep disorder.
Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ) Immediately following the study period (up to approximately 2 weeks) The PSPQ provides information about sleep timing and consistency of sleep timing across weekends versus weekdays. The total score is standardized to a T-score with a mean of 50 and a standard deviation of 10.
Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ) Immediately following the study period (up to approximately 2 weeks) Chronotypes are natural preferences of the body for wakefulness and sleep. Morning to Evening (M/E) scale-scores range from 10 (extreme morningness) to 49 (extreme eveningness). Morning types are classified by a M/E scale score of ≤23, intermediate types by a score of 24-32, and evening types by a score ≥33.
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States