Performance evaluation of a wrist-worn reflectance pulse oximeter during sleep

Objectives: To characterize and evaluate the estimation of oxygen saturation measured by a wrist-worn reflectance pulse oximeter during sleep. Methods: Ninety-seven adults with sleep disturbances were enrolled. Oxygen saturation was simultaneously measured using a reflectance pulse oximeter (Galaxy Watch 4 [GW4], Samsung, South Korea) and a transmittance pulse oximeter (polysomnography) as a reference. The performance of the device was evaluated using the root mean squared error (RMSE) and coverage rate. Additionally, GW4-derived oxygen desaturation index (ODI) was compared with the apnea-hypopnea index (AHI) derived from polysomnography. Results: The GW4 had an overall RMSE of 2.3% and negligible bias of -0.2%. A Bland-Altman density plot showed good agreement between the GW4 and the reference pulse oximeter. RMSEs were 1.65 ± 0.57%, 1.76 ± 0.65%, 1.93 ± 0.54%, and 2.93 ± 1.71% for normal (n = 18), mild (n = 21), moderate (n = 23), and severe obstructive sleep apnea (n = 35), respectively. The data rejection rate was 26.5%, which was caused by fluctuations in contact pressure and the discarding of data less than 70% of saturation. A GW4-ODI ≥5/h had the highest ability to predict AHI ≥15/h with sensitivity, specificity, accuracy, and area under the curve of 89.7%, 64.1%, 79.4%, and 0.908, respectively. Conclusions: This study evaluated the estimation of oxygen saturation by the GW4 during sleep. This device complies with both Food and Drug Administration and International Organization for Standardization standards. Further improvements in the algorithms of wearable devices are required to obtain more accurate and reliable information about oxygen saturation measurements.