Comparing Fitbit® Quality of Measured Sleep to Sleep Meas... | NCT03066479

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

NCT03066479

Sponsor

Vidya Raman

Status

Completed

Last Update Posted

Mar 16, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Fitbit
OSA questionnaire
Polysomnography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 4, 2015Actual

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Feb 16, 2017

First Submission Date that Met QC Criteria

Feb 23, 2017

First Posted Date

Feb 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2017

Last Update Posted Date

Mar 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vidya Raman, Clinical Associate Professor of Anesthesiology, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Vidya RamanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fitbit	Experimental	Patients will wear a Fitbit bracelet during their sleep study.	Device: Fitbit Other: OSA questionnaire Diagnostic Test: Polysomnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fitbit	Device	Wearable activity & sleep tracker.	Fitbit
OSA questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017286	Polysomnography

Ancestor Terms

ID	Term
D008991	Monitoring, Physiologic
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided