Sleep Apnea SyndromesVPASSNCT04234828
Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome
An observational study of Sleep Apnea Syndromes, run by Withings at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea Syndromes
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jul 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for an in-lab PSG exam
Who may be able to join
- adults, men or women, aged between 18 and 70
- patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre
Brussels, 1000
France1 site
Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère
Clamart, 92140
About this study
Official title: 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.
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea, Sleep Apnea Syndromes, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Signs and Symptoms, Sleep Apnea, Obstructive, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Apnea
- Medical subject headings
- Sleep Apnea Syndromes, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Signs and Symptoms, Sleep Apnea, Obstructive, Sleep Disorders, Intrinsic, Dyssomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for an overnight in-lab PSG | Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediately after intervention
Secondary outcomes (10)
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.
Measured: 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.
Measured: immediately after intervention
Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG
Bias and mean absolute error (MAE)
Measured: immediately after intervention
Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG
Bias and MAE
Measured: immediately after intervention
Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG
Bias and MAE
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after intervention
Reliability of Withings Sleep
Rate of unusable or lost nights.
Measured: immediately after intervention
Reliability of PSG
Rate of unusable or lost nights.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start3 Jul 2019
- Primary completion1 May 2020
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Garbiel Roisman, Principal investigator, Hôpital Antoine Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234828
- Sponsor's protocol ID
- 2019-A00977-50
- Acronym
- VPASS
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2019
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33590821
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Diagnostic Performance of the Withings Sleep Device in Detecting Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT04234828
- Acronym / sponsor ID
- VPASS / 2019-A00977-50
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea, Sleep Apnea Syndromes, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Signs and Symptoms, Sleep Apnea, Obstructive, Sleep Disorders, Intrinsic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for an overnight in-lab PSG | – | –Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for an in-lab PSG exam
Key inclusion criteria (2 listed)
- adults, men or women, aged between 18 and 70
- patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
10 secondary outcomes
Sensitivity and specificity of polygraphy (PG)
Time frame: immediately after intervention
Sensitivity and specificity of PG
Time frame: immediately after intervention
Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG
Time frame: immediately after intervention
Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG
Time frame: immediately after intervention
Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG
Time frame: 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
Time frame: immediately after intervention
Impact of the proportion of hypopnea events on the performance of Withings Sleep
Time frame: immediately after intervention
Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events.
Time frame: immediately after intervention
Reliability of Withings Sleep
Time frame: immediately after intervention
Reliability of PSG
Time frame: immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 33590821Edouard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garbiel Roisman principal investigator
Hôpital Antoine Béclère
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, run by Withings at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG (time frame: immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.