Polysomnography validation of SANSA to detect obstructive sleep apnea
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)...
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Frontiers Media S.A.
2025-06-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2025.1592690/full |
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| author | Cathy Goldstein Hamid Ghanbari Surina Sharma Nancy Collop Andrew Namen Douglas B. Kirsch Michael Drucker Rami Khayat Mark Pollock Brennan Torstrick Colleen Walsh Emily Herreshoff David S. Frankel Ilene M. Rosen |
| author_facet | Cathy Goldstein Hamid Ghanbari Surina Sharma Nancy Collop Andrew Namen Douglas B. Kirsch Michael Drucker Rami Khayat Mark Pollock Brennan Torstrick Colleen Walsh Emily Herreshoff David S. Frankel Ilene M. Rosen |
| author_sort | Cathy Goldstein |
| collection | DOAJ |
| description | 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] |
| format | Article |
| id | doaj-art-1a992a17c1bf4243b95f2b7195fd10b8 |
| institution | DOAJ |
| issn | 1664-2295 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Neurology |
| spelling | doaj-art-1a992a17c1bf4243b95f2b7195fd10b82025-08-20T03:20:10ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-06-011610.3389/fneur.2025.15926901592690Polysomnography validation of SANSA to detect obstructive sleep apneaCathy Goldstein0Hamid Ghanbari1Surina Sharma2Nancy Collop3Andrew Namen4Douglas B. Kirsch5Michael Drucker6Rami Khayat7Mark Pollock8Brennan Torstrick9Colleen Walsh10Emily Herreshoff11David S. Frankel12Ilene M. Rosen13Department of Neurology, University of Michigan, Ann Arbor, MI, United StatesDivision of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, United StatesEmory Sleep Center, Emory University, Atlanta, GA, United StatesEmory Sleep Center, Emory University, Atlanta, GA, United StatesAtrium Wake Forest Baptist, Winston-Salem, NC, United StatesAtrium Health Sleep Medicine, Charlotte, NC, United StatesNovant Health Cardiology, Winston-Salem, NC, United StatesDivision of Pulmonary, Allergy, and Critical Care, Penn State Health and the Sleep Research and Treatment Center, Pennsylvania State University, Hershey, PA, United StatesPulmonary & Sleep Specialists, Atlanta, GA, United StatesHuxley Medical, Inc., Atlanta, GA, United States0Division of Sleep Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United StatesDepartment of Neurology, University of Michigan, Ann Arbor, MI, United States1Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States0Division of Sleep Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United StatesStudy 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]https://www.frontiersin.org/articles/10.3389/fneur.2025.1592690/fullsleep disordered breathingsleep apneacardiac arrhythmiaatrial fibrillationhome sleep apnea testingwearable diagnostic devices |
| spellingShingle | Cathy Goldstein Hamid Ghanbari Surina Sharma Nancy Collop Andrew Namen Douglas B. Kirsch Michael Drucker Rami Khayat Mark Pollock Brennan Torstrick Colleen Walsh Emily Herreshoff David S. Frankel Ilene M. Rosen Polysomnography validation of SANSA to detect obstructive sleep apnea Frontiers in Neurology sleep disordered breathing sleep apnea cardiac arrhythmia atrial fibrillation home sleep apnea testing wearable diagnostic devices |
| title | Polysomnography validation of SANSA to detect obstructive sleep apnea |
| title_full | Polysomnography validation of SANSA to detect obstructive sleep apnea |
| title_fullStr | Polysomnography validation of SANSA to detect obstructive sleep apnea |
| title_full_unstemmed | Polysomnography validation of SANSA to detect obstructive sleep apnea |
| title_short | Polysomnography validation of SANSA to detect obstructive sleep apnea |
| title_sort | polysomnography validation of sansa to detect obstructive sleep apnea |
| topic | sleep disordered breathing sleep apnea cardiac arrhythmia atrial fibrillation home sleep apnea testing wearable diagnostic devices |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2025.1592690/full |
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