Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:11 - 17
Updated:4/3/2019
Start Date:March 27, 2019
End Date:December 31, 2019
Contact:Leah Akins, MSc
Email:leah.l.akins@duke.edu
Phone:919-681-0013

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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.

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.

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.
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Durham, North Carolina 27705
Phone: 919-681-0035
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