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.
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 Type
OBSERVATIONAL
Enrollment
220
Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.
St Pierre Hospital
Brussels, Belgium
Antoine Béclère Hospital
Clamart, Île-de-France Region, France
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
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)
Time frame: 1 year
Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG
Bias and mean absolute error (MAE)
Time frame: 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
Time frame: 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
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
Average difference of AHI between Withings HWA09 and the PSG in each position
Time frame: 1 year
Reliability of Withings HWA09
Rate of unusable of lost nights
Time frame: 1 year
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