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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients referred for an overnight in-lab PSG | Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | immediately after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after intervention |
| Sensitivity and specificity of PG |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referred for an in-lab PSG exam
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| Name | Affiliation | Role |
|---|---|---|
| Garbiel Roisman | Hôpital Antoine Béclère | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre | Brussels | 1000 | Belgium | |||
| Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33590821 | Derived | 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. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D020181 | Sleep Apnea, Obstructive |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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Sensitivity and specificity for SAS detection by PG compared to PSG at AHI threshold values of 30/h in PSG.
| immediately after intervention |
| Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG | Bias and mean absolute error (MAE) | immediately after intervention |
| Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG | Bias and MAE | immediately after intervention |
| Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG | Bias and MAE | 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. | 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. | 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. | immediately after intervention |
| Reliability of Withings Sleep | Rate of unusable or lost nights. | immediately after intervention |
| Reliability of PSG | Rate of unusable or lost nights. | immediately after intervention |
| Clamart |
| 92140 |
| France |