ORIGINAL RESEARCH article
Front. Neurol.
Sec. Sleep Disorders
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1592690
This article is part of the Research TopicThe Promise of Sleep TechnologyView all articles
Polysomnography validation of SANSA to detect obstructive sleep apnea
Provisionally accepted
Cathy Goldstein1*
Hamid Ghanbari1Surina Sharma2Nancy Collop2Andrew Namen3Douglas Kirsch4Michael Drucker5Rami Khayat6Mark Pollock7
Brennan Torstrick8Colleen Walsh9Emily Herreshoff1David Frankel9Ilene Rosen9- 1University of Michigan, Ann Arbor, Michigan, United States
- 2Emory University, Atlanta, Georgia, United States
- 3Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
- 4Atrium Healthcare, Charlotte, North Carolina, United States
- 5Novant Health, Winston-Salem, North Carolina, United States
- 6The Pennsylvania State University (PSU), University Park, Pennsylvania, United States
- 7Pulmonary & Sleep Specialists, Atlanta, United States
- 8Huxley Medical, Inc., Atlanta, United States
- 9University of Pennsylvania, Philadelphia, Pennsylvania, United States
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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/hour), moderate-to-severe (≥15 events/hour), and severe (≥30 events/hour) 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%).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.
Keywords: Sleep disordered breathing, Sleep Apnea, cardiac arrhythmia, Atrial Fibrillation, Home sleep apnea testing, Wearable Diagnostic Devices
Received: 12 Mar 2025; Accepted: 29 May 2025.
Copyright: © 2025 Goldstein, Ghanbari, Sharma, Collop, Namen, Kirsch, Drucker, Khayat, Pollock, Torstrick, Walsh, Herreshoff, Frankel and Rosen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Cathy Goldstein, University of Michigan, Ann Arbor, 48109, Michigan, United States
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