Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-9
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Children with ADHD ages 6-9 in the Duke University Health System
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Circadian Rhythm (Sleep Timing)
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
Nightly for 7 nights (at-home assessment)2
DLMO - Dim Light Melatonin Onset
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
Day 8 (second in-person study visit)Secondary outcomes
1
Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ)
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)2
Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ)
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)3
Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ)
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.
Time frame
Immediately following the study period (up to approximately 2 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov