ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, attention deficit disorder with hyperactivity, circadian rhythm, dim light melatonin onset
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.
Interventions
None listed
Sponsors
Duke University
National Institute of Mental Health (NIMH)
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Garmin Vivosmart 5 will continuously measure movement and heart rate. |
| DLMO - Dim Light Melatonin Onset | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTMatt Gibson
CONTACTJessica Lunsford-Avery, Ph.D.
PRINCIPAL_INVESTIGATORJessica Lunsford-Avery, Ph.D.
Duke University
Outcome results
None listed