Back to resultsComparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit
OSA questionnaire
Polysomnography
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fitbit
Arm Description
Patients will wear a Fitbit bracelet during their sleep study.
Outcomes
Primary Outcome Measures
Total sleep time
Compare the sleep times recorded on the Fitbit vs the sleep study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03066479
Brief Title
Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
Official Title
Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 4, 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vidya Raman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fitbit
Arm Type
Experimental
Arm Description
Patients will wear a Fitbit bracelet during their sleep study.
Intervention Type
Device
Intervention Name(s)
Fitbit
Intervention Description
Wearable activity & sleep tracker.
Intervention Type
Other
Intervention Name(s)
OSA questionnaire
Intervention Description
Parents will complete a questionnaire assessing the potential symptoms their child is experiencing that are related to obstructive sleep apnea (OSA).
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography
Other Intervention Name(s)
Sleep study
Intervention Description
All participants will be undergoing a sleep study as part of their clinical care.
Primary Outcome Measure Information:
Title
Total sleep time
Description
Compare the sleep times recorded on the Fitbit vs the sleep study.
Time Frame
At the end of the sleep study - average 6 hrs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
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