Duke University Medical Center
Durham, North Carolina, 27705, United States
Location status: Recruiting
NCT Number: NCT06971640
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.
Interested in participating?
Request Info6 year–9 year
All sexes
Observational
Durham, North Carolina, 27705, United States
Location status: Recruiting
Participants will be asked to review and sign a consent form to enroll. As part of the study, participants will:
Participants will be compensated for their time.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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 Garmin Vivosmart 5 will continuously measure movement and heart rate.
Time frame: Day 8 (second in-person study visit)
Salivary melatonin will be collected during an in-lab assessment, occurring on Friday night following the home assessment. Eleven saliva samples (~2ml) will be collected in a darkened environment every 30 min for a period beginning 4 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Jessica Lunsford-Avery, Ph.D.
CONTACT
Matt Gibson
CONTACT
Duke University
Other
Acronym: CIRCA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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