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NCT04496843: VPASH

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

Active, enrolled Last updated 18 February 2026
What this trial tests

trial testing HWA09 Measurement in Sleep Apnea in 220 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
16 January 2020
Primary endpoint
31 January 2021
31 December 2026

Quick facts

Lead sponsorWithings
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment220
Start date16 January 2020
Primary completion31 January 2021
Estimated completion31 December 2026
Sites2 locations across Belgium, France

Drugs / interventions tested

Conditions studied

Sponsor

Withings — full company profile →

Who can join

Adults 18 to 70, any sex, with Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Sleep Apnea

Currently open trials in the same condition.

Other Withings trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04496843.

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