Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome
- Conditions
- Sleep Apnea Syndromes
- Registration Number
- NCT04234828
- Lead Sponsor
- Withings
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- adults, men or women, aged between 18 and 70
- patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG 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 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 Outcome Measures
Name Time Method Sensitivity and specificity of polygraphy (PG) immediately after intervention Sensitivity and specificity for SAS detection by polygraphy (PG) compared to PSG at AHI threshold values of 15/h in PSG.
Sensitivity and specificity of PG immediately after intervention Sensitivity and specificity for SAS detection by PG compared to PSG at AHI threshold values of 30/h in PSG.
Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG immediately after intervention Bias and mean absolute error (MAE)
Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG immediately after intervention Bias and MAE
Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG immediately after intervention Bias and MAE
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 immediately after intervention Mean group difference between sleepers more than 50% of TST in decubitus dorsal or not.
Impact of the proportion of hypopnea events on the performance of Withings Sleep immediately after intervention Mean group difference between patients with a majority of apnea events and patients with a majority of hypopnea events.
Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events. 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.
Reliability of Withings Sleep immediately after intervention Rate of unusable or lost nights.
Reliability of PSG immediately after intervention Rate of unusable or lost nights.
Trial Locations
- Locations (2)
Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre
🇧🇪Brussels, Belgium
Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère
🇫🇷Clamart, France