Abstract
STUDY OBJECTIVES: Evaluate the performance of a novel home sleep apnea test with embedded ECG (SANSA, Huxley Medical, Inc.) in the diagnosis of obstructive sleep apnea (OSA). METHODS: This prospective multicenter validation study included 340 participants who underwent simultaneous polysomnography (PSG) and SANSA recordings across 7 clinical sites. Participants were diverse across age, sex, race, skin tone, and body mass index. Diagnostic performance was assessed with the apnea-hypopnea index (AHI) using both Rule 1A and Rule 1B across standard cutoffs for mild, moderate, or severe (≥5 events/h), moderate-to-severe (≥15 events/h), and severe (≥30 events/h) OSA. The agreement for AHI and total sleep time (TST) between SANSA and consensus PSG scores from three independent scorers was evaluated using Pearson's correlation and Bland-Altman analysis. Sensitivity and specificity were calculated at each OSA severity level. Performance of participating site PSG scores were also evaluated against consensus PSG scores for comparison. RESULTS: SANSA demonstrated excellent agreement with PSG for most performance parameters. AHI correlation was 0.91 (95% CI: 0.89, 0.93) using Rule 1B and 0.90 (95% CI: 0.87, 0.92) using Rule 1A. Compared to consensus scored PSG, the device detected moderate-to-severe OSA using Rule 1B (the primary endpoint) with a sensitivity of 88% (95% CI: 81, 93%) and specificity of 87% (95% CI: 82, 91%), while site PSG sensitivity was 89% (95% CI: 82, 94%) and specificity was 93% (95% CI: 88, 96%). SANSA TST highly correlated with PSG TST (R = 0.82, 95% CI: 0.78, 0.85) and classified sleep epochs with an accuracy of 87.2% (95% CI: 87.0, 87.5%). CONCLUSION: The SANSA home sleep apnea test demonstrated robust diagnostic performance for OSA detection including measurement of sleep compared to PSG. Its patch morphology and embedded ECG confer ease of use and multi-diagnostic potential in sleep medicine and cardiology for the detection of OSA and cardiac arrhythmias across diverse clinical populations. CLINICAL TRIAL REGISTRATION: [https://www.clinicaltrials.gov/study/NCT06070389], identifier [NCT06070389].