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

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ClinicalTrials.gov Identifier: NCT03066479
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Vidya Raman, Nationwide Children's Hospital

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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Fitbit Other: OSA questionnaire Diagnostic Test: Polysomnography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
Actual Study Start Date : August 4, 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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 Name: Sleep study




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066479


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Vidya Raman

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Responsible Party: Vidya Raman, Clinical Associate Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03066479     History of Changes
Other Study ID Numbers: IRB15-00331
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases