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

Withings

Status

Unknown

Conditions

Sleep Apnea

Treatments

Diagnostic Test: HWA09 Measurement

Study type

Observational

Funder types

Industry

Identifiers

NCT04496843

2019-A01347-50

Details and patient eligibility

About

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.

Full description

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.

Enrollment

220 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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