Clinical validation of respiratory outcomes for a patch-based polysomnography system

Study Objectives The Onera Sleep Test System (STS), the first wireless, patch-based, type-II polysomnography (PSG) device designed to enable unattended sleep studies at the patient's home, has been introduced. This multicentre study validated data collected from the patch-based PSG against traditional PSG for the classification of sleep-related respiratory events. Materials and methods Seven clinical sites recruited 206 participants to complete a simultaneous sleep study in the sleep laboratory with a traditional PSG and a patch-based PSG system. Three independent scorers, blinded to patient and device type, evaluated the traditional PSG and patch-based PSG recordings in accordance with AASM 2020 (Version 2.6) guidelines. Results The subjects were middle aged and mildly obese (50.9±12.3 years of age, BMI 30.2±6.2). There was strong positive correlation between the Apnoea-Hypopnea Index (AHI – using 3% desaturation or arousal rule) (0.90), Apnoea Index (0.89), Central Apnoea Index (0.78), Obstructive Apnoea Index (0.86), Hypopnea Index (0.68) and Arousal Index (0.72) measured by the two devices. Differences in oxygen saturation (SpO2) measurement were seen as a function of measurement site with the forehead measurements showing higher SpO2 values. The patch-based device showed diagnostic utility (AUC≥0.8) for AHI severity thresholds at 5, 15 and 30.