Clinical Trial

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

Study acronym: VPASH
Active, Not Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-07-30.
Status change: Recruiting → Active, Not Recruiting 2026-02-17
Trial Details
NCT Number NCT04496843
Lead Sponsor Withings
Conditions Sleep Apnea
Enrollment 220 participants
Start Date 2020-01-16
Primary Completion 2021-01-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-18