Clinical trial NCT03843762: Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks
Official title: Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Behavior
Keywords: Adolescents
Sleep
Actigraphy
Psychiatric Health
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 106
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents will be recruited from primary and specialty health clinics.

Brief summary: The overall goal of this study is to investigate associations between sleep/circadian disturbances and psychiatric health among adolescents recruited from primary and specialty health clinics.

Detailed description: This project will involve recruitment of 100 adolescents from primary and specialty health clinics. Participants will participate in 3 phases: screening/intake visit, sleep study, and follow-up visit.

The 1-hour screening/intake visit will be conducted at the Duke ADHD clinic at 2608 Erwin Road, Pavilion East, Suite 300, Durham, NC 27705. During the screening/intake visit, participants and their parents will complete questionnaires regarding the adolescent's psychiatric health. Participants' vitals (i.e., height, weight, resting heart rate, blood pressure) will also be assessed and recorded.

Eligible participants will enter the 7-day sleep study, during which they will be asked to wear an actigraph watch 24 hours/day, apply a EEG sleep recorder each night, and complete a daily sleep diary.

Following the final night of the sleep study, participants and parents will be asked to return for a follow-up visit and will complete questionnaires about the participants' sleep over the past week.

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Between the ages of 11 years 0 months to 17 years 11 months (inclusive), at the time of parental informed consent.
3. Ability to follow written and verbal instructions (English), as assessed by the PI and/or study coordinator.
4. Ability to comply with all testing, requirements, study procedures, and availability for the duration of the study.

Exclusion Criteria:

1. Participants who have a diagnosis of occult sleep disorders (i.e., sleep apnea, periodic leg movement syndrome)
2. Participants who currently use prescribed or over-the-counter sleep aids (i.e., melatonin)
3. Participants who have acute or chronic medical illnesses or medications that may interfere with sleep as determined by the research team.
4. Unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the principal investigator.

Primary outcomes:
measure: Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood
timeFrame: 1 Day
Secondary outcomes:
measure: Acceptability of Devices - Tolerability Scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jessica R Lunsford-Avery, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lunsford-Avery JR, Keller C, Kollins SH, Krystal AD, Jackson L, Engelhard MM. Feasibility and Acceptability of Wearable Sleep Electroencephalogram Device Use in Adolescents: Observational Study. JMIR Mhealth Uhealth. 2020 Oct 1;8(10):e20590. doi: 10.2196/20590.