Clinical validation of a multisensor wearable device (SOUNDI) for the diagnosis of obstructive sleep apnea (OSA).

Obstructive sleep apnea (OSA) is a common disorder with significant health and economic burdens and the current standard of diagnosis is performed through polysomnography. This study assesed the diagnostic accuracy of SOUNDI, a novel wearable device that uses optical, acoustical, and accelerometer signals for home sleep testing. Fifty patients suspected of having OSA underwent simultaneous monitoring with standard Type 3 cardiorespiratory monitoring (PG) and SOUNDI system. The apnea‒hypopnea index (AHI), oxygen desaturation index and oxygen saturation parameters derived from SOUNDI were highly correlated (r = 0.87-0.99, p < 0.0001) and were in good agreement with the PG. SOUNDI study was shown to have excellent specificity and positive predictive value (PPV) at various AHI values ( AHI ≥ 5/h: specificity = 0.769, PPV = 0.919; AHI ≥ 15/h: specificity = 0.852, PPV = 0.833; AHI ≥ 30/h: specificity = 0.833, PPV = 0.100). Patient feedback highlighted significant satisfaction with the wearingability and ease of use of the SOUNDI, indicating a preference for multi-night monitoring. The findings suggest that the SOUNDI offers a patient-centric and potentially cost-effective alternative to PG for OSA diagnosis in the home setting.