Sleep ApneaVPASHNCT04496843
Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device
An observational study of Sleep Apnea, 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
- What is being tested?
- HWA09 Measurement
- How many people
- 220 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jan 2020to 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
- Adult, Older adult
Study population: Patients referred for an in-lab polysomnography
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea
- Being tested
- HWA09 Measurement
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HWA09 MeasurementDiagnostic test
Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for an overnight in-lab PSG | Simultaneous assessment of SAS with Withings HWA09 Device and overnight PSG Receives: Diagnostic Test: HWA09 Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (6)
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)
Measured: 1 year
Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG
Bias and mean absolute error (MAE)
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Reliability of Withings HWA09
Rate of unusable of lost nights
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start16 Jan 2020
- Primary completion31 Jan 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Roisman, Principal investigator, Antoine Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496843
- Sponsor's protocol ID
- 2019-A01347-50
- Acronym
- VPASH
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2020
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Sleep Apnea Syndrome by the Withings HWA09 Device
- ClinicalTrials.gov ID
- NCT04496843
- Acronym / sponsor ID
- VPASH / 2019-A01347-50
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for an overnight in-lab PSG | – | Diagnostic Test: HWA09 MeasurementSimultaneous assessment of SAS with Withings HWA09 Device and overnight PSG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients referred for an in-lab polysomnography
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HWA09 MeasurementSimultaneous recording of Withings HWA09 Device and PSG devices for the reference. | Diagnostic test | Patients referred for an overnight in-lab PSG |
Primary outcome
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.
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.
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.
6 secondary outcomes
Sensitivity and Specificity of the desaturation detected by Withings HWA09
Time frame: 1 year
Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG
Time frame: 1 year
Impact of the proportion of apnea events on the performance of Withings HWA09
Time frame: 1 year
Impact of the proportion of hypopnea events on the performance of Withings HWA09
Time frame: 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
Time frame: 1 year
Reliability of Withings HWA09
Time frame: 1 year
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.
- 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.
Gabriel Roisman principal investigator
Antoine Béclère Hospital
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, 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 3 inclusion and 8 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 HWA09 at AHI threshold value of 5/h in PSG (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.