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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967367
• Other study ID #: AK/15-06-67/4522
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2019
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• high clinical suspicion of obstructive sleep apnea syndrome

Exclusion Criteria:

• other associated sleep disorder

• inability to sign informed consent

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Belgium	CHu Saint Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Bed	time spent in bed during the night (minutes)	one night (up to 600 minutes)
Primary	Sleep Efficiency	a percentage corresponding to total sleep time divided by time in bed	one night (up to 600 minutes)
Primary	Total Sleep Time	time spent sleeping during the night (minutes)	one night (up to 600 minutes)
Secondary	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)
Secondary	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)