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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02967367

Enrollment

Registered

2016-11-18

Start date

2016-09-30

Completion date

2017-02-28

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

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.

Interventions

DEVICEJawbone sleep tracker

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

DEVICEWithings sleep tracker

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

DEVICEBodyMedia Sense Wear accelerometer

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* high clinical suspicion of obstructive sleep apnea syndrome

Exclusion criteria

* other associated sleep disorder * inability to sign informed consent

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Participant flow

Participants by arm

Arm	Count
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 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	22
Total	22

Arm

Count

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 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

Total

Baseline characteristics

Characteristic	Jawbone/Withings Sleep Trackers, Bodymedia Sensewear	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	4 Participants	—
Age, Categorical Between 18 and 65 years	18 Participants	—
Age, Continuous	53 years STANDARD_DEVIATION 13	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	5 Participants	—
Sex: Female, Male Male	17 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 22
other Total, other adverse events	0 / 22
serious Total, serious adverse events	0 / 22