Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome

NCT ID: NCT02967367

Last Updated: 2020-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-02-28

Brief Summary

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During last years, numerous sleep trackers have been commercialized. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep.

For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).

The purpose of the present study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

Detailed Description

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During last years, numerous sleep trackers have been commercialized. They are working on accelerometer-based technology. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep..

For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).

The purpose of our study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Jawbone/Withings sleep trackers, Bodymedia Sensewear

2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients

Group Type EXPERIMENTAL

Jawbone sleep tracker

Intervention Type DEVICE

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Withings sleep tracker

Intervention Type DEVICE

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

BodyMedia Sense Wear accelerometer

Intervention Type DEVICE

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Interventions

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Jawbone sleep tracker

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Intervention Type DEVICE

Withings sleep tracker

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Intervention Type DEVICE

BodyMedia Sense Wear accelerometer

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Intervention Type DEVICE

Other Intervention Names

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accelerometer

Eligibility Criteria

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Inclusion Criteria

* high clinical suspicion of obstructive sleep apnea syndrome

Exclusion Criteria

* other associated sleep disorder
* inability to sign informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Bruyneel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Saint Pierre

Locations

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CHu Saint Pierre

Brussels, , Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AK/15-06-67/4522

Identifier Type: -

Identifier Source: org_study_id

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