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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Jawbone sleep tracker; Device: Withings sleep tracker; Device: BodyMedia Sense Wear accelerometer

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • CHU Saint Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• high clinical suspicion of obstructive sleep apnea syndrome

Exclusion Criteria:

• other associated sleep disorder
• inability to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Bed	time spent in bed during the night (minutes)	one night (up to 600 minutes)
Sleep Efficiency	a percentage corresponding to total sleep time divided by time in bed	one night (up to 600 minutes)
Total Sleep Time	time spent sleeping during the night (minutes)	one night (up to 600 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep Sleep	a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time	one night (up to 600 minutes)
Light Sleep	a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time	one night (up to 600 minutes)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Investigators: Principal Investigator: Marie Bruyneel, MD PhD, Centre Hospitalier Universitaire Saint Pierre

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: AK/15-06-67/4522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO