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

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ClinicalTrials.gov Identifier: NCT02967367
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: Jawbone sleep tracker Device: Withings sleep tracker Device: BodyMedia Sense Wear accelerometer Not Applicable

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.


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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: Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
Study Start Date : September 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 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
Device: Jawbone sleep tracker
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Other Name: accelerometer

Device: Withings sleep tracker
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

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




Primary Outcome Measures :
  1. time in bed [ Time Frame: one night (minutes) ]
    time spent in bed during the night (minutes)

  2. sleep efficiency [ Time Frame: one night (minutes) ]
    a percentage corresponding to total sleep time divided by time in bed

  3. total sleep time [ Time Frame: one night (minutes) ]
    time spent sleeping during the night (minutes)


Secondary Outcome Measures :
  1. deep sleep [ Time Frame: one night (minutes) ]
    a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time

  2. light sleep [ Time Frame: one night (minutes) ]
    a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high clinical suspicion of obstructive sleep apnea syndrome

Exclusion Criteria:

  • other associated sleep disorder
  • inability to sign informed consent

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): NCT02967367


Locations
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Belgium
CHu Saint Pierre
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Principal Investigator: Marie Bruyneel, MD PhD Centre Hospitalier Universitaire Saint Pierre

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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT02967367     History of Changes
Other Study ID Numbers: AK/15-06-67/4522
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Apnea
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases