用于检测阻塞性睡眠呼吸暂停的SANSA的多导睡眠图验证

Polysomnography validation of SANSA to detect obstructive sleep apnea.

作者信息

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

机构信息

Department of Neurology, University of Michigan, Ann Arbor, MI, United States.

Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, United States.

出版信息

Front Neurol. 2025 Jun 16;16:1592690. doi: 10.3389/fneur.2025.1592690. eCollection 2025.

DOI:10.3389/fneur.2025.1592690

PMID:40589991

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12206633/

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 ( = 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].

摘要

研究目的

评估一种新型的带有嵌入式心电图的家庭睡眠呼吸暂停测试（SANSA，赫胥黎医疗公司）在阻塞性睡眠呼吸暂停（OSA）诊断中的性能。

方法

这项前瞻性多中心验证研究纳入了340名参与者，他们在7个临床地点同时接受了多导睡眠图（PSG）和SANSA记录。参与者在年龄、性别、种族、肤色和体重指数方面具有多样性。使用呼吸暂停低通气指数（AHI），按照轻度、中度或重度（≥5次事件/小时）、中度至重度（≥15次事件/小时）和重度（≥30次事件/小时）OSA的标准临界值，采用规则1A和规则1B评估诊断性能。使用Pearson相关性分析和Bland-Altman分析评估SANSA与来自三位独立评分者的共识PSG评分之间的AHI和总睡眠时间（TST）的一致性。计算每个OSA严重程度水平的敏感性和特异性。还针对共识PSG评分评估了参与站点PSG评分的性能，以进行比较。

结果

对于大多数性能参数，SANSA与PSG显示出极好的一致性。使用规则1B时AHI相关性为0.91（95%CI：0.89，0.93），使用规则1A时为0.90（95%CI：0.87，0.92）。与共识评分的PSG相比，该设备使用规则1B（主要终点）检测中度至重度OSA的敏感性为88%（95%CI：81，93%），特异性为87%（95%CI：82，91%），而站点PSG的敏感性为89%（95%CI：82，94%），特异性为93%（95%CI：88，96%）。SANSA的TST与PSG的TST高度相关（r = 0.82，95%CI：0.78，0.85），对睡眠阶段分类的准确率为87.2%（95%CI：87.0，87.5%）。