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NCT Number: NCT04234828

Validation of Withings Sleep for the Detection of 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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: immediately after intervention

    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.

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

    Time frame: immediately after intervention

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

Secondary outcomes

  1. Sensitivity and specificity of polygraphy (PG)

    Time frame: immediately after intervention

    Sensitivity and specificity for SAS detection by polygraphy (PG) compared to PSG at AHI threshold values of 15/h in PSG.

  2. Sensitivity and specificity of PG

    Time frame: immediately after intervention

    Sensitivity and specificity for SAS detection by PG compared to PSG at AHI threshold values of 30/h in PSG.

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

    Time frame: immediately after intervention

    Bias and mean absolute error (MAE)

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

    Time frame: immediately after intervention

    Bias and MAE

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

    Time frame: immediately after intervention

    Bias and MAE

  6. 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

    Time frame: immediately after intervention

    Mean group difference between sleepers more than 50% of TST in decubitus dorsal or not.

  7. Impact of the proportion of hypopnea events on the performance of Withings Sleep

    Time frame: immediately after intervention

    Mean group difference between patients with a majority of apnea events and patients with a majority of hypopnea events.

  8. Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events.

    Time frame: immediately after intervention

    Mean group difference between patients with a majority of central or mixed apnea events and patients with a majority of obstructive apnea events.

  9. Reliability of Withings Sleep

    Time frame: immediately after intervention

    Rate of unusable or lost nights.

  10. Reliability of PSG

    Time frame: immediately after intervention

    Rate of unusable or lost nights.

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Official study title

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

Acronym: VPASS

Important dates

Study start
2019
Primary completion
2020
Study completion
2026
First posted
Jan 21, 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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