AUTHOR=Goldstein Cathy , Ghanbari Hamid , Sharma Surina , Collop Nancy , Namen Andrew , Kirsch Douglas B. , Drucker Michael , Khayat Rami , Pollock Mark , Torstrick Brennan , Walsh Colleen , Herreshoff Emily , Frankel David S. , Rosen Ilene M. 

TITLE=Polysomnography validation of SANSA to detect obstructive sleep apnea

JOURNAL=Frontiers in Neurology

VOLUME=Volume 16 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1592690

DOI=10.3389/fneur.2025.1592690

ISSN=1664-2295

ABSTRACT=Study objectivesEvaluate the performance of a novel home sleep apnea test with embedded ECG (SANSA, Huxley Medical, Inc.) in the diagnosis of obstructive sleep apnea (OSA).MethodsThis 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.ResultsSANSA 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%).ConclusionThe 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]