NCT03066479

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

February 16, 2017

Last Update Submit

March 15, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Fitbit

EXPERIMENTAL

Patients will wear a Fitbit bracelet during their sleep study.

Device: FitbitOther: OSA questionnaireDiagnostic Test: Polysomnography

Interventions

FitbitDEVICE

Wearable activity \& sleep tracker.

Fitbit
OSA questionnaireOTHER

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

Fitbit
PolysomnographyDIAGNOSTIC_TEST

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

Also known as: Sleep study
Fitbit

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who consent/assent to wearing Fitbit® band over wrist overnight during sleep study and parents who consent to answering questionnaire.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor of Anesthesiology

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 28, 2017

Study Start

August 4, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 16, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)