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

NCT04496843 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

HWA09 Measurement

Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.

Sponsors & Collaborators

  • Withings

    lead INDUSTRY

Principal Investigators

  • Gabriel Roisman · Antoine Béclère Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2021-01-31
Completion
2026-12-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496843 on ClinicalTrials.gov