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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea Syndromes

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: David Campo; Phone Number: +33 1 41 46 04 60; Email: david.campo@withings.com
• Study Contact Backup: Name: Pierre Escourrou, PhD; Phone Number: +33 6 81 71 79 03; Email: pierre.escourrou@aphp.fr

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Active, not recruiting
    • Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre
• France
  • Clamart, France, 92140
    • Recruiting
    • Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère
    • Contact: Pierre Escourrou; Phone Number: +33 6 81 71 79 03; Email: pierre.escourrou@aphp.fr
    • Principal Investigator: Gabriel Roisman
    • Sub-Investigator: Michel Petitjean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for an in-lab PSG exam

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients referred for an overnight in-lab PSG; Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of polygraphy (PG)	Sensitivity and specificity for SAS detection by polygraphy (PG) compared to PSG at AHI threshold values of 15/h in PSG.	immediately after intervention
Sensitivity and specificity of PG	Sensitivity and specificity for SAS detection by PG compared to PSG at AHI threshold values of 30/h in PSG.	immediately after intervention
Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG	Bias and mean absolute error (MAE)	immediately after intervention
Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG	Bias and MAE	immediately after intervention
Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG	Bias and MAE	immediately after intervention
Influence of the position of the sleeper (decubitus dorsal vs decubitus latero-ventral) on the error of the AHI predicted by Withings Sleep compared with PSG	Mean group difference between sleepers more than 50% of TST in decubitus dorsal or not.	immediately after intervention
Impact of the proportion of hypopnea events on the performance of Withings Sleep	Mean group difference between patients with a majority of apnea events and patients with a majority of hypopnea events.	immediately after intervention
Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events.	Mean group difference between patients with a majority of central or mixed apnea events and patients with a majority of obstructive apnea events.	immediately after intervention
Reliability of Withings Sleep	Rate of unusable or lost nights.	immediately after intervention
Reliability of PSG	Rate of unusable or lost nights.	immediately after intervention

Collaborators and Investigators

• Sponsor: Withings
• Investigators: Principal Investigator: Garbiel Roisman, Hôpital Antoine Béclère

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2019
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ANTICIPATED): January 31, 2021

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (ACTUAL): January 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Sleep Apnea; Nervous System Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Signs and Symptoms; Sleep Disorders, Intrinsic; Apnea; Respiration Disorders; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Syndrome; Apnea
• Other Study ID Numbers: 2019-A00977-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No