Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome

NCT04234828 | Active Not Recruiting

• 1 other identifier: 2019-A00977-50
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Sleep Apnea Syndromes

Keywords

Sleep Apnea; Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Apnea

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG

  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.

  immediately after intervention

• Sensitivity and specificity of Withings Sleep at AHI threshold value of 30/h in PSG

  Sensitivity and specificity for SAS detection by Withings Sleep compared to PSG at AHI threshold value of 30/h in PSG.

  immediately after intervention

Secondary Outcomes (10)

• Sensitivity and specificity of polygraphy (PG)

  immediately after intervention

• Sensitivity and specificity of PG

  immediately after intervention

• Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG

  immediately after intervention

• Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG

  immediately after intervention

• Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG

  immediately after intervention

Study Arms (1)

Patients referred for an overnight in-lab PSG

Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for an in-lab PSG exam

You may qualify if:

• adults, men or women, aged between 18 and 70
• patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing

You may not qualify if:

• 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

Sponsors & Collaborators

• Withings: lead

Study Sites (2)

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

Brussels, 1000, Belgium

Location

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

Clamart, 92140, France

Location

Related Publications (1)

• Edouard P, Campo D, Bartet P, Yang RY, Bruyneel M, Roisman G, Escourrou P. Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome. J Clin Sleep Med. 2021 Jun 1;17(6):1217-1227. doi: 10.5664/jcsm.9168.

  PMID: 33590821 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Apnea

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Mental Disorders; Neurologic Manifestations

Study Officials

• Garbiel Roisman

  Hôpital Antoine Béclère

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: January 21, 2020
• Study Start: July 3, 2019
• Primary Completion: May 1, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); BE (1)