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Clinical Trials in Belgium / NCT04234828
Active, not recruiting Observational

Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome

NCT04234828 · tracked via the Priya Life Science Belgium tracker
Sponsor
Withings
Phase
Observational
Started
2019-07-03
Last updated
2026-02-18

Condition(s) studied

Sleep Apnea Syndromes

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 Sleep is a non-contact device, along with an airbag placed under the mattress, which allows screening of SAS from four signals: movement, breathing, heart rate and snoring. The objective of the present study is to validate the diagnostic performance of the Withings Sleep 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 or women, aged between 18 and 70 * patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing Exclusion Criteria: * children less than 18 years of age * patients treated with continuous positive airway pressure * person not giving her consent * vulnerable subject according to current regulation: * pregnant woman, parturient or breastfeeding * subject deprived of freedom by judicial, medical or administrative decision * subject legally protected or unable to express his consent * subject non-beneficiary of healthcare * subject falling into more than one of the above categories * subject in linguistic or psychic incapacity to express his consent

Primary outcome measure(s)

  • Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG — immediately after intervention
    Sensitivity and specificity for SAS detection by Withings Sleep compared to polysomnography (PSG) at apnea-hypopnea index (AHI) threshold value of 15/h in PSG.
  • Sensitivity and specificity of Withings Sleep at AHI threshold value of 30/h in PSG — immediately after intervention
    Sensitivity and specificity for SAS detection by Withings Sleep compared to PSG at AHI threshold value of 30/h in PSG.

Trial sites (2)

FacilityCityRegionStatus
Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre Brussels Belgium
Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère Clamart France

More Withings trials in Belgium

Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device Active, not 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 NCT04234828 on ClinicalTrials.gov ↗ ← All trials in Belgium