Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome

Abstract

Study objectives: To assess the diagnostic performance of a nonintrusive device placed under the mattress to detect sleep apnea syndrome.

Methods: One hundred eighteen patients suspected to have obstructive sleep apnea syndrome completed a night at a sleep clinic with a simultaneous polysomnography (PSG) and recording with the Withings Sleep Analyzers. PSG nights were scored twice: first as simple polygraphy, then as PSG.

Results: Average (standard deviation) apnea-hypopnea index from PSG was 31.2 events/h (25.0) and 32.8 events/h (29.9) according to the Withings Sleep Analyzers. The mean absolute error was 9.5 events/h. The sensitivity, specificity, and area under the receiver operating characteristic curve at thresholds of apnea-hypopnea index ≥ 15 events/h were, respectively, sensitivity (Se)15 = 88.0%, specificity (Sp)15 = 88.6%, and area under the receiver operating characteristic curve (AUROC) 15 = 0.926. At the threshold of apnea-hypopnea index ≥ 30 events/h, results included Se30 = 86.0%, Sp30 = 91.2%, AUROC30 = 0.954. The average total sleep time from PSG and the Withings Sleep Analyzers was 366.6 (61.2) and 392.4 (67.2) minutes, sleep efficiency was 82.5% (11.6) and 82.6% (11.6), and wake after sleep onset was 62.7 (48.0) and 45.2 (37.3) minutes, respectively.

Conclusions: Withings Sleep Analyzers accurately detect moderate-severe sleep apnea syndrome in patients suspected of sleep apnea syndrome. This simple and automated approach could be of great clinical value given the high prevalence of sleep apnea syndrome in the general population.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome; URL: https://ichgcp.net/clinical-trials-registry/NCT04234828; Identifier: NCT04234828.

Keywords: deep learning; e-health; home monitoring; polygraphy; polysomnography; screening; sleep apnea; under-the-mattress sensor.

Conflict of interest statement

All authors have seen and approved this manuscript. Work for this study was performed at the Sleep Medicine Department, Antoine-Béclère Hospital, Clamart, France and Chest Service, Saint-Pierre University Hospital, Brussels, Belgium. The sleep analyzers used in this study were provided by Withings, Issy-les-Moulineaux, France. Paul Edouard, David Campo, Pierre Bartet, and Rui-Yi Yang are employees of Withings. Pierre Escourrou is a consultant for Withings. The remaining authors report no conflicts of interest.

© 2021 American Academy of Sleep Medicine.

Figures

Figure 1. WSA hardware.

Dimensions (A) and components (B). WSA = Withings Sleep Analyzer.

Figure 2. AHI from PSG and WSA.

Correlation (A) and Bland-Altman analysis (B) of AHI from PSG and WSA. AHI = apnea-hypopnea index, LoA = limits of agreement, PSG = polysomnography, WSA = Withings Sleep Analyzer.

Figure 3. ROC curves of WSA compared to PSG at an AHI threshold of 15 and 30 events/h.

AHI = apnea-hypopnea index, PSG = polysomnography, ROC = receiver operating characteristic, WSA = Withings Sleep Analyzer.

Figure 4. AHI from PSG and PG.

Correlation (A) and Bland-Altman analysis (B) of AHI from PSG and PG. AHI = apnea-hypopnea index, LOA = limits of Aareement, PG = polygraphy, PSG = polysomnography.

Figure 5. ROC curves of PG compared to PSG at an AHI threshold of 15 and 30 events/h.

AHI = apnea-hypopnea index, PG = polygraphy, PSG = polysomnography, ROC = receiver operating characteristic.