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NCT04496843: VPASH
Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device
trial testing HWA09 Measurement in Sleep Apnea in 220 participants. Participants enrolled and being followed up; not accepting new ones.
31 January 2021
Quick facts
| Lead sponsor | Withings |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 220 |
| Start date | 16 January 2020 |
| Primary completion | 31 January 2021 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across Belgium, France |
Drugs / interventions tested
- HWA09 Measurement
Conditions studied
- Sleep Apnea — all drugs for Sleep Apnea →
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.
Verify or expand the search:
- PubMed search for NCT04496843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Sleep Apnea
Currently open trials in the same condition.
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Other Withings trials
Trials by the same sponsor.
- NCT06957847 — Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 (WIHYP-GP) · NA · completed
- NCT06692413 — Withings Devices Follow-up Study - Hypertension · withdrawn
- NCT06351761 — WIBOFA - Validation of SCT02 With ECG-App for Detection of AF · NA · completed
- NCT05823025 — Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales (WIVOP-Scales) · active not recruiting
- NCT05316337 — Withings ECG-Monitor Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04496843 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Withings
- Last refreshed: 18 February 2026
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing