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ACTIVE NOT RECRUITING
NCT04234828

Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome

Sponsor: Withings

View on ClinicalTrials.gov

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.

Official title: Validation of the Diagnostic Performance of the Withings Sleep Device in Detecting Sleep Apnea Syndrome

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2019-07-03

Completion Date

2026-12-31

Last Updated

2026-02-18

Healthy Volunteers

No

Locations (2)

Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre

Brussels, Belgium

Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère

Clamart, France