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OpenTrials
Completed

NCT Number: NCT03066479

Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab

This study is to evaluate a commercial tool on the market (Fitbit®) that also quantifies sleep. No one has studied how pediatric patients perform with it and how accurate it is in measuring their quality of sleep. This study will use the obstructive sleep apnea (OSA) questionnaire completed by parents and Fitbit® together and evaluate how they perform against the polysomnography (PSG).

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who consent/assent to wearing Fitbit® band over wrist overnight during sleep study and parents who consent to answering questionnaire.

Exclusion criteria

  • None

Treatment and study plan

Fitbit

Device

Wearable activity & sleep tracker.

OSA questionnaire

Other

Parents will complete a questionnaire assessing the potential symptoms their child is experiencing that are related to obstructive sleep apnea (OSA).

Polysomnography

Diagnostic Test

All participants will be undergoing a sleep study as part of their clinical care.

Other names: Sleep study

Primary outcomes

  1. Total sleep time

    Time frame: At the end of the sleep study - average 6 hrs.

    Compare the sleep times recorded on the Fitbit vs the sleep study.

Sponsors and collaborators

Lead sponsor

Vidya Raman

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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