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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066479
• Other study ID #: IRB15-00331
• Status: Completed
• Phase: N/A
• First received: February 16, 2017
• Last updated: March 15, 2017
• Start date: August 4, 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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:

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Vidya Raman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time	Compare the sleep times recorded on the Fitbit vs the sleep study.	At the end of the sleep study - average 6 hrs.