NCT04496843

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Withings · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HWA09 Measurement	Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.

Timeline

• Start date: 2020-01-16
• Primary completion: 2021-01-31
• Completion: 2026-12-31
• First posted: 2020-08-03
• Last updated: 2026-02-18

Locations

2 sites across 2 countries: Belgium, France