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Clinical Trials in France / NCT04496843
Active, not recruiting Observational

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

NCT04496843 · tracked via the Priya Life Science France tracker
Sponsor
Withings
Phase
Observational
Started
2020-01-16
Last updated
2026-02-18

Condition(s) studied

Sleep Apnea

Investigational drug(s) / intervention(s)

HWA09 Measurement

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Adults, men and women, between 18 and 70 y/o * Patient addressed for a polysomnography because of a suspicion of sleep respiratory disorders * Subject having expressed his/her consent to take part in the study Exclusion Criteria: * Recording under continuous positive pressure * Subject having refuse to give his/her consent * Vulnerable subjects according to regulation in force : * Pregnant, parturient or breastfeeding women * Subjects having a known allergy to one of the components of the sensor (silicon, stainless steel, sapphire glass) * Subjects deprived of liberty by a court, medical or administrative order * Subjects legally protected or unable to express their non-opposition to take part in the study * Subjects unable to express their consent due to linguistic or mental incapacities

Primary outcome measure(s)

  • Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 5/h in PSG — 1 year
    Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at apnea-hypopnea index (AHI) threshold value of 5/h in PSG.
  • Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 15/h in PSG — 1 year
    Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 15/h in PSG.
  • Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 30/h in PSG — 1 year
    Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 30/h in PSG.

Trial sites (2)

FacilityCityRegionStatus
St Pierre Hospital Brussels Belgium
Antoine Béclère Hospital Clamart Île-de-France Region

More Withings trials in France

Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales (WIVOP-Scales) Active, not recruiting
Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection Active, not recruiting
Withings Hypertension Notification Retrospective Study Active, not recruiting
Smart Devices-based Longitudinal Assessment of Patterns of Insomnia Enrolling by invitation
Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation Active, not recruiting

Other trials for the same condition

Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) Recruiting
Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension Recruiting
New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04496843 on ClinicalTrials.gov ↗ ← All trials in France