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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Jawbone sleep tracker
Withings sleep tracker
BodyMedia Sense Wear accelerometer
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • high clinical suspicion of obstructive sleep apnea syndrome

Exclusion Criteria:

  • other associated sleep disorder
  • inability to sign informed consent

Sites / Locations

  • CHu Saint Pierre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jawbone/Withings sleep trackers, Bodymedia Sensewear

Arm Description

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

Outcomes

Primary Outcome Measures

Time in Bed
time spent in bed during the night (minutes)
Sleep Efficiency
a percentage corresponding to total sleep time divided by time in bed
Total Sleep Time
time spent sleeping during the night (minutes)

Secondary Outcome Measures

Deep Sleep
a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time
Light Sleep
a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time

Full Information

First Posted
September 5, 2016
Last Updated
March 12, 2020
Sponsor
Centre Hospitalier Universitaire Saint Pierre
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1. Study Identification

Unique Protocol Identification Number
NCT02967367
Brief Title
Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
Official Title
Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jawbone/Withings sleep trackers, Bodymedia Sensewear
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Jawbone sleep tracker
Other Intervention Name(s)
accelerometer
Intervention Description
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Intervention Type
Device
Intervention Name(s)
Withings sleep tracker
Intervention Description
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Intervention Type
Device
Intervention Name(s)
BodyMedia Sense Wear accelerometer
Intervention Description
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Primary Outcome Measure Information:
Title
Time in Bed
Description
time spent in bed during the night (minutes)
Time Frame
one night (up to 600 minutes)
Title
Sleep Efficiency
Description
a percentage corresponding to total sleep time divided by time in bed
Time Frame
one night (up to 600 minutes)
Title
Total Sleep Time
Description
time spent sleeping during the night (minutes)
Time Frame
one night (up to 600 minutes)
Secondary Outcome Measure Information:
Title
Deep Sleep
Description
a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time
Time Frame
one night (up to 600 minutes)
Title
Light Sleep
Description
a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time
Time Frame
one night (up to 600 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: high clinical suspicion of obstructive sleep apnea syndrome Exclusion Criteria: other associated sleep disorder inability to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bruyneel, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire Saint Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHu Saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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