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

Adolescent Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843762
• Other study ID #: Pro00101670
• Status: Completed
• Start date: May 6, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior

Locations

Country	Name	City	State
United States	Duke Child and Family Study Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood	"Internalizing symptoms" and "Externalizing symptoms" subscales of the Child Behavior Checklist (CBCL)	1 Day
Secondary	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