Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-16

Study Completion Date

2021-01-31

Brief Summary

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Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.

Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.

The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals: movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the present study is to validate the diagnostic performance of the Withings HWA09 for the detection of SAS compared to PSG.

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Detailed Description

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Subjects are patients having a prescription for a one-night polysomnographic consultation in order to diagnose potential sleep disorders. The investigator will collect the consent before including any patient in this study. The study last one night per patient, during which saturation signal recordings and the sleep apnea detection will be made by the HWA09 watch, in comparison to the polysomnography.

Conditions

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Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients referred for an overnight in-lab PSG

Simultaneous assessment of SAS with Withings HWA09 Device and overnight PSG

HWA09 Measurement

Intervention Type DIAGNOSTIC_TEST

Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.

Interventions

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HWA09 Measurement

Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults, men and women, between 18 and 70 y/o
* Patient addressed for a polysomnography because of a suspicion of sleep respiratory disorders
* Subject having expressed his/her consent to take part in the study

Exclusion Criteria

* Recording under continuous positive pressure
* Subject having refuse to give his/her consent
* Vulnerable subjects according to regulation in force :
* Pregnant, parturient or breastfeeding women
* Subjects having a known allergy to one of the components of the sensor (silicon, stainless steel, sapphire glass)
* Subjects deprived of liberty by a court, medical or administrative order
* Subjects legally protected or unable to express their non-opposition to take part in the study
* Subjects unable to express their consent due to linguistic or mental incapacities

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No