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CompletedNCT03066479Updated Mar 16, 2017

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

An interventional study of Fitbit and OSA questionnaire in Obstructive Sleep Apnea, sponsored by Vidya Raman. Completed at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-16.

Sponsored by Vidya Raman · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Aug 2015, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
3 Years to 18 Years
Sex
All
01

Study 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).

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Conditions studied

  • Obstructive Sleep Apnea
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In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's enrollment of 20 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Vidya Raman is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Fitbit

    Patients will wear a Fitbit bracelet during their sleep study.

    Device: Fitbit · Other: OSA questionnaire · Diagnostic Test: Polysomnography

Interventions

  • DeviceFitbit

    Wearable activity \& sleep tracker.

  • OtherOSA questionnaire

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

  • Diagnostic testPolysomnography

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

    Also known as: Sleep study

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What researchers measure

Primary outcomes

  1. Total sleep time

    Compare the sleep times recorded on the Fitbit vs the sleep study.

    Time frame: At the end of the sleep study - average 6 hrs.

07

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03066479
Lead sponsor
Vidya Raman
Responsible party
Vidya Raman (Clinical Associate Professor of Anesthesiology, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Feb 28, 2017
Start date
Aug 4, 2015
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Mar 16, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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