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

March 15, 2017 updated by: Vidya Raman
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fitbit
Patients will wear a Fitbit bracelet during their sleep study.
Device: Fitbit
Wearable activity & sleep tracker.
Other: OSA questionnaire
Parents will complete a questionnaire assessing the potential symptoms their child is experiencing that are related to obstructive sleep apnea (OSA).
Diagnostic test: Polysomnography
All participants will be undergoing a sleep study as part of their clinical care.
Other Names:
  • Sleep study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the sleep study - average 6 hrs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vidya Raman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-00331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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