Multi-diagnostic chest-worn patch to detect obstructive sleep apnea and cardiac arrhythmias.

Abstract

Study objectives: Evaluate the performance of the SANSA device to simultaneously assess obstructive sleep apnea (OSA) and cardiac arrhythmias.

Methods: Participants suspected or known to have OSA underwent polysomnography (PSG) while wearing SANSA. SANSA's algorithm was trained using 86 records and tested on 67 to evaluate training bias. SANSA performance was evaluated against ground truth PSG scored by the consensus of three technologists. PSG scoring from individual testing sites was also evaluated against consensus. Diagnostic performance was evaluated using standard apnea-hypopnea index (AHI) cutoffs. AHI and total sleep time (TST) agreement was analyzed using correlation and Bland-Altman plots. ECG was reviewed for presence of significant arrhythmias (frequent premature atrial/ventricular complexes and atrial fibrillation).

Results: SANSA's sensitivity and specificity to detect OSA ranged from 91-97% and 78-97%, respectively, across all severity levels. SANSA TST correlation with Consensus PSG TST was 0.83 with a mean difference of 3.8 minutes (limits of agreement: -91.1 to 98.7). Significant arrhythmias were detected in 32% of participants. These participants had a greater AHI (27.5 versus 15.8, P=0.003) and spent nearly twice as long at reduced oxygenation levels (47.5 versus 20.5 minutes under 88% SpO₂, P = 0.009).

Conclusions: SANSA is a promising tool for comprehensive OSA evaluation, offering the unique advantage of concurrent arrhythmia detection. This dual functionality may improve patient outcomes through early diagnosis and management of both conditions.