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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Fitbit; Other: OSA questionnaire; Diagnostic Test: Polysomnography

• Registration Number: NCT03066479
• Lead Sponsor: Vidya Raman

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-04
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fitbit	Fitbit	Patients will wear a Fitbit bracelet during their sleep study.
Fitbit	OSA questionnaire	Patients will wear a Fitbit bracelet during their sleep study.
Fitbit	Polysomnography	Patients will wear a Fitbit bracelet during their sleep study.

Primary Outcome Measures

Name	Time	Method
Total sleep time	At the end of the sleep study - average 6 hrs.	Compare the sleep times recorded on the Fitbit vs the sleep study.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States