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

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.

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 American Academy of Sleep Medicine (AASM) 2020 (Version 2.6) guidelines.

The subjects were middle aged and mildly obese (50.9±12.3 years of age, body mass index 30.2±6.2). There was strong positive correlation between the apnoea-hypopnoea index ((AHI) using 3% desaturation or arousal rule) (0.90), apnoea index (0.89), central apnoea index (0.78), obstructive apnoea index (0.86), hypopnoea index (0.68) and arousal index (0.72) measured by the two devices. Differences in oxygen saturation (S _pO2 ) measurement were seen as a function of measurement site with the forehead measurements showing higher S _pO2 values. The patch-based device showed diagnostic utility (AUC ≥0.8) for AHI severity thresholds at 5, 15 and 30.

The Onera STS patch-based PSG system demonstrated reasonably good agreement with traditional PSG systems in detecting sleep-disordered breathing events and in diagnosing obstructive sleep apnoea by the AHI.