Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device (VPASH)

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 HWA09 is a wrist-worn watch, which allows screening of SAS from four signals: movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the present study is to validate the diagnostic performance of the Withings HWA09 for the detection of SAS compared to PSG.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea
• Intervention / Treatment: Diagnostic test: HWA09 Measurement

Detailed Description

Subjects are patients having a prescription for a one-night polysomnographic consultation in order to diagnose potential sleep disorders. The investigator will collect the consent before including any patient in this study. The study last one night per patient, during which saturation signal recordings and the sleep apnea detection will be made by the HWA09 watch, in comparison to the polysomnography.

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

• Study Contact: Name: Delphine Ladarré, PhD; Phone Number: +33 6 75 12 23 80; Email: delphine.ladarre@withings.com
• Study Contact Backup: Name: Ruiyi Yang, PhD; Phone Number: +33 6 19 78 25 54; Email: ruiyi.yang@withings.com

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Completed
    • St Pierre Hospital
• France
  • Ile-de-France
    • Clamart, Ile-de-France, France, 92140
      • Recruiting
      • Antoine Beclère Hospital
      • Contact: Gabriel Roisman; Phone Number: + 33 1 45 37 48 19; Email: gabriel.roisman@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for an in-lab polysomnography

Description

Inclusion Criteria:

• Adults, men and women, between 18 and 70 y/o
• Patient addressed for a polysomnography because of a suspicion of sleep respiratory disorders
• Subject having expressed his/her consent to take part in the study

Exclusion Criteria:

• Recording under continuous positive pressure
• Subject having refuse to give his/her consent
• Vulnerable subjects according to regulation in force :
• Pregnant, parturient or breastfeeding women
• Subjects having a known allergy to one of the components of the sensor (silicon, stainless steel, sapphire glass)
• Subjects deprived of liberty by a court, medical or administrative order
• Subjects legally protected or unable to express their non-opposition to take part in the study
• Subjects unable to express their consent due to linguistic or mental incapacities

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients referred for an overnight in-lab PSG; Simultaneous assessment of SAS with Withings HWA09 Device and overnight PSG	Diagnostic test: HWA09 Measurement; Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 5/h in PSG	Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at apnea-hypopnea index (AHI) threshold value of 5/h in PSG.	1 year
Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 15/h in PSG	Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 15/h in PSG.	1 year
Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 30/h in PSG	Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 30/h in PSG.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of the desaturation detected by Withings HWA09	Sensitivity and specificity of the desaturation detection by Withings HWA09 compared to an oximeter with the Oxygen Desaturation Index (ODI)	1 year
Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG	Bias and mean absolute error (MAE)	1 year
Impact of the proportion of apnea events on the performance of Withings HWA09	Bias and MAE for apnea index (AI) estimated by Withings HWA09 compared to PSG results	1 year
Impact of the proportion of hypopnea events on the performance of Withings HWA09	Bias and MAE for hypopnea index (HI) estimated by Withings HWA09 compared to PSG results	1 year
Influence of the position of the sleeper (supine vs prone/lateral decubitus position) on the error of the AHI predicted by Withings HWA09 compared with PSG	Average difference of AHI between Withings HWA09 and the PSG in each position	1 year
Reliability of Withings HWA09	Rate of unusable of lost nights	1 year

Collaborators and Investigators

• Sponsor: Withings
• Investigators: Principal Investigator: Gabriel Roisman, Antoine Beclère Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2020
• Primary Completion (ANTICIPATED): January 31, 2021
• Study Completion (ANTICIPATED): January 31, 2021

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (ACTUAL): August 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 2019-A01347-50

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