Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome

Last updated: July 27, 2020
Sponsor: Withings
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT04234828
2019-A00977-50
  • Ages 18-70
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • adults, men or women, aged between 18 and 70

  • patients referred for an overnight polysomnographic exam for a suspicion ofsleep-disordered breathing

Exclusion

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

Study Design

Total Participants: 200
Study Start date:
July 03, 2019
Estimated Completion Date:
January 31, 2021

Connect with a study center

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

    Brussels, 1000
    Belgium

    Site Not Available

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

    Clamart, 92140
    France

    Active - Recruiting

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