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

NCT04496843 | Active Not Recruiting

• 1 other identifier: 2019-A01347-50
• Study Type: observational
• Target: 220
• 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 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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Sensitivity and Specificity of the desaturation detected by Withings HWA09

  1 year

• Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG

  1 year

• Impact of the proportion of apnea events on the performance of Withings HWA09

  1 year

• Impact of the proportion of hypopnea events on the performance of Withings HWA09

  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

  1 year

Study Arms (1)

Patients referred for an overnight in-lab PSG

Simultaneous assessment of SAS with Withings HWA09 Device and overnight PSG

Diagnostic Test: HWA09 Measurement

Interventions

HWA09 Measurement DIAGNOSTIC_TEST

Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.

Patients referred for an overnight in-lab PSG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for an in-lab polysomnography

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Withings: lead

Study Sites (2)

St Pierre Hospital

Brussels, 1000, Belgium

Location

Antoine Béclère Hospital

Clamart, Île-de-France Region, 92140, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Gabriel Roisman

  Antoine Béclère Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 3, 2020
• Study Start: January 16, 2020
• Primary Completion: January 31, 2021
• 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)