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

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Behavior

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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Child and Family Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescents will be recruited from primary and specialty health clinics.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adolescents; Adolescents, male or female, ages 11 - 17. Participants will complete 7 days/nights of actigraphy and sleep-based EEG and questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood	"Internalizing symptoms" and "Externalizing symptoms" subscales of the Child Behavior Checklist (CBCL)	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Devices - Tolerability Scale	Tolerability will be assessed using the At Home PSG Tolerability Scale, developed by Dr. Lunsford-Avery (PI) and colleagues. This scale measures comfort of devices while asleep and awake, sleep disturbances resulting from device use, and satisfaction with the devices.	1 day

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Jessica R Lunsford-Avery, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Adolescents; Sleep; Actigraphy; Psychiatric Health
• Other Study ID Numbers: Pro00101670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No