Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study.

BACKGROUND: A decrease in the level of pulse oxygen saturation as measured by pulse oximetry (SpO2) is an indicator of hypoxemia that may occur in various respiratory diseases, such as chronic obstructive pulmonary disease (COPD), sleep apnea syndrome, and COVID-19. Currently, no mass-market wrist-worn SpO2 monitor meets the medical standards for pulse oximeters. OBJECTIVE: The main objective of this monocentric and prospective clinical study with single-blind analysis was to test and validate the accuracy of the reflective pulse oximeter function of the Withings ScanWatch to measure SpO2 levels at different stages of hypoxia. The secondary objective was to confirm the safety of this device when used as intended. METHODS: To achieve these objectives, we included 14 healthy participants aged 23-39 years in the study, and we induced several stable plateaus of arterial oxygen saturation (SaO2) ranging from 100%-70% to mimic nonhypoxic conditions and then mild, moderate, and severe hypoxic conditions. We measured the SpO2 level with a Withings ScanWatch on each participant's wrist and the SaO2 from blood samples with a co-oximeter, the ABL90 hemoximeter (Radiometer Medical ApS). RESULTS: After removal of the inconclusive measurements, we obtained 275 and 244 conclusive measurements with the two ScanWatches on the participants' right and left wrists, respectively, evenly distributed among the 3 predetermined SpO2 groups: SpO2≤80%, 80%

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

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://clinicaltrials.gov/ct2/show/NCT04234828; Identifier: NCT04234828.

Measurement of Aortic Pulse Wave Velocity With a Connected Bathroom Scale.

BACKGROUND: Measurement of arterial stiffness should be more available. Our aim was to show that aortic pulse wave velocity can be reliably measured with a bathroom scale combining the principles of ballistocardiography (BCG) and impedance plethysmography on a single foot. METHOD: The calibration of the bathroom scale was conducted on a group of 106 individuals. The aortic pulse wave velocity was measured with the SphygmoCor in the supine position. Three consecutive measurements were then performed on the Withings scale in the standing position. This aorta-leg pulse transit time (alPTT) was then converted into a velocity with the additional input of the height of the person. Agreement between the SphygmoCor and the bathroom scale so calibrated is assessed on a separate group of 86 individuals, following the same protocol. RESULTS: The bias is 0.25 m·s-1 and the SE 1.39 m·s-1. This agreement with Sphygmocor is "acceptable" according to the ARTERY classification. The alPTT correlated well with cfPTT with (Spearman) R = 0.73 in pooled population (cal 0.79, val 0.66). The aorta-leg pulse wave velocity correlated with carotid-femoral pulse wave velocity with R = 0.76 (cal 0.80, val 0.70). CONCLUSION: Estimation of the aortic pulse wave velocity is feasible with a bathroom scale. Further investigations are needed to improve the repeatability of measurements and to test their accuracy in different populations and conditions.