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

NCT ID: NCT03066479

Last Updated: 2017-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-04

Study Completion Date

2017-02-28

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fitbit

Patients will wear a Fitbit bracelet during their sleep study.

Group Type EXPERIMENTAL

Fitbit

Intervention Type DEVICE

Wearable activity \& sleep tracker.

OSA questionnaire

Intervention Type OTHER

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

Polysomnography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Fitbit

Wearable activity \& sleep tracker.

Intervention Type DEVICE

OSA questionnaire

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

Intervention Type OTHER

Polysomnography

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Sleep study

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vidya Raman

OTHER

Sponsor Role lead

Responsible Party

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Vidya Raman

Clinical Associate Professor of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB15-00331

Identifier Type: -

Identifier Source: org_study_id

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