Abstract Introduction Quantitative assessment of sleep is essential for diagnosing sleep disorders and evaluating treatment efficacy. Polysomnography (PSG), in a laboratory setting, is considered the gold standard for objective sleep assessment, however PSG is resource-intensive, expensive, and can disrupt a patient's normal sleep pattern. Wearable devices based on dry-printed electrode arrays have emerged as a practical and accessible promising alternative to traditional PSG for skin electrophysiology during sleep. Dry printed electrodes offer several advantages, such as signal stability, ease of application especially in the home environment setting, and patient convenience. While wearable devices offer a convenient and simple solution, their accuracy, and particularly concerning metrics like Total Sleep Time (TST) and Apnea Hypopnea Index (AHI), must be validated against the established gold-standard in-laboratory polysomnography. In previous studies we showed accuracy to polysomnography signals and basic sleep stages scoring. This study compares TST and AHI measurements obtained from manual scoring from the tested wearable device with those derived from full PSG. Methods This validation study included 10 healthy subjects as a preparation for additional 40 subjects with suspected sleep disorders. Each subject was connected to both systems simultaneously, the PSG and the tested system. The subjects were monitored during a complete night in a sleep facility. The tested system comprises two novel multi-electrode patches for face and chest including EEG, EOG, EMG, ECG, SpO2 wrist sensor, a wireless recording device, and a mobile application. The raw data from both systems scored manually by the same scorer and compared for validation purposes. The Oxygen Desaturation Index (ODI) scored manually from the SpO2 of the tested device and was compared to the AHI of the PSG. Results The agreement between the TST values of both systems ranged from 93% to 98.8% with an average of 96.5%. Comparing the Oxygen Desaturation Index (ODI) to the AHI of the full PSG shows good agreement with higher correlation in higher values of AHI. Conclusion The parameters agreement of the healthy subjects between the systems is very successful and promising toward the challenge of acquiring high quality medical grade signals at home environment during full night of sleep. Support (if any)
Penzel et al. (Fri,) studied this question.