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NCT Number: NCT04496843

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St Pierre Hospital, Brussels, Belgium

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HWA09 Measurement

Diagnostic Test

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

Primary outcomes

  1. Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 5/h in PSG

    Time frame: 1 year

    Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at apnea-hypopnea index (AHI) threshold value of 5/h in PSG.

  2. Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 15/h in PSG

    Time frame: 1 year

    Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 15/h in PSG.

  3. Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 30/h in PSG

    Time frame: 1 year

    Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 30/h in PSG.

Secondary outcomes

  1. Sensitivity and Specificity of the desaturation detected by Withings HWA09

    Time frame: 1 year

    Sensitivity and specificity of the desaturation detection by Withings HWA09 compared to an oximeter with the Oxygen Desaturation Index (ODI)

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

    Time frame: 1 year

    Bias and mean absolute error (MAE)

  3. Impact of the proportion of apnea events on the performance of Withings HWA09

    Time frame: 1 year

    Bias and MAE for apnea index (AI) estimated by Withings HWA09 compared to PSG results

  4. Impact of the proportion of hypopnea events on the performance of Withings HWA09

    Time frame: 1 year

    Bias and MAE for hypopnea index (HI) estimated by Withings HWA09 compared to PSG results

  5. 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

    Time frame: 1 year

    Average difference of AHI between Withings HWA09 and the PSG in each position

  6. Reliability of Withings HWA09

    Time frame: 1 year

    Rate of unusable of lost nights

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Acronym: VPASH

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
Aug 3, 2020
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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