Validation of contact-free sleep monitoring device with comparison to polysomnography

Study Objectives: To validate a contact-free system designed to achieve maximal comfort during long-term sleep monitoring, together with high monitoring accuracy. Methods: We used a contact-free monitoring system (EarlySense, Ltd., Israel), comprising an under-the-mattress piezoelectric sensor and a smartphone application, to collect vital signs and analyze sleep. Heart rate (HR), respiratory rate (RR), body movement, and calculated sleep-related parameters from the EarlySense (ES) sensor were compared to data simultaneously generated by the gold standard, polysomnography (PSG). Subjects in the sleep laboratory underwent overnight technician-attended full PSG, whereas subjects at home were recorded for 1 to 3 nights with portable partial PSG devices. Data were compared epoch by epoch. Results: A total of 63 subjects (85 nights) were recorded under a variety of sleep conditions. Compared to PSG, the contact-free system showed similar values for average total sleep time (TST), % wake, % rapid eye movement, and % non-rapid eye movement sleep, with 96.1% and 93.3% accuracy of continuous measurement of HR and RR, respectively. We found a linear correlation between TST measured by the sensor and TST determined by PSG, with a coefficient of 0.98 (R = 0.87). Epoch-by-epoch comparison with PSG in the sleep laboratory setting revealed that the system showed sleep detection sensitivity, specificity, and accuracy of 92.5%, 80.4%, and 90.5%, respectively. Conclusions: TST estimates with the contact-free sleep monitoring system were closely correlated with the gold-standard reference. This system shows good sleep staging capability with improved performance over accelerometer-based apps, and collects additional physiological information on heart rate and respiratory rate.