Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome (VPASS)

Withings

Status: Unknown

Conditions: Sleep Apnea Syndromes

Study type: Observational

Funder types: Industry

Identifiers

NCT04234828

2019-A00977-50

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patients referred for an overnight in-lab PSG

Description:

Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG