Status:

COMPLETED

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

Lead Sponsor:

Duke University

Conditions:

Adolescent Behavior

Eligibility:

All Genders

11-17 years

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....

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

May 6 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 16 2020

Estimated Enrollment :

106 Patients enrolled

Trial Details

Trial ID

NCT03843762

Start Date

May 6 2019

End Date

March 16 2020

Last Update

April 27 2020

Active Locations (1)

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Duke Child and Family Study Center

Durham, North Carolina, United States, 27705