基于穿戴式心肺耦合监测的阻塞性睡眠呼吸 暂停早期筛查及临床诊断价值分析

Early Screening and Clinical Diagnostic Value Analysis of Obstructive Sleep Apnea Based on Wearable Cardiopulmonary Coupling Monitoring

摘要: 目的：旨在评估增强型穿戴式心肺耦合监测设备(SF-C20-M)在阻塞性睡眠呼吸暂停(OSA)早期筛查及临床辅助诊断中的应用价值与准确性。方法：本研究采用前瞻性自身对照设计，纳入90例疑似睡眠呼吸障碍患者，分别进行穿戴式设备(SF-C20-M)与标准多导睡眠监测系统(SF-A30S)的整夜睡眠监测。重点评估两设备在呼吸暂停低通气指数(AHI)、睡眠事件分期及血氧参数等核心临床指标上的一致性，并通过Bland-Altman分析、组内相关系数(ICC)和Kappa检验评估其诊断分级效能。结果：穿戴式设备与对照系统在AHI测量上表现出极高的临床一致性(ICC = 0.9998)，Bland-Altman分析显示平均偏差仅0.10次/h。在OSA诊断分级(正常、轻、中、重度)方面，两者一致率达98.9% (Kappa = 0.984)。以AHI ≥ 5次/h为筛查阈值，穿戴式设备的诊断敏感度高达100.0%，特异度为92.3%；在中重度OSA (AHI ≥ 15次/h)的识别上，敏感度与特异度均达到100.0%。结论：增强型穿戴式睡眠监测设备在OSA的临床筛查与病情严重程度分级中具有与标准系统高度一致的诊断效能。其在保证高敏感度的同时，有效提升了居家监测的便捷性与患者依从性，可作为OSA早期筛查、分级诊疗及慢病管理的可靠临床工具。

Abstract: Objective: To evaluate the application value and accuracy of enhanced wearable cardiopulmonary coupling monitoring equipment (SF-C20-M) in early screening and clinical auxiliary diagnosis of obstructive sleep apnea (OSA). Methods: In this study, a prospective self-control design was adopted, and 90 patients with suspected sleep-disordered breathing were included, and the whole night sleep was monitored by wearable devices (SF-C20-M) and standard polysomnography system (SF-A30S) respectively. The consistency of core clinical indicators such as apnea hypopnea index (AHI), sleep event staging and blood oxygen parameters between the two devices was evaluated, and the diagnostic grading efficiency was evaluated by Bland-Altman analysis, intra-group correlation coefficient (ICC) and Kappa test. Results: The wearable device and the control system showed a very high clinical consistency in AHI measurement (ICC = 0.9998), and the average deviation was only 0.10 times/h by Bland-Altman analysis. In terms of diagnosis classification of OSA (normal, mild, moderate and severe), the coincidence rate between them was 98.9% (Kappa = 0.984). Taking AHI ≥ 5 times/h as the screening threshold, the diagnostic sensitivity of wearable devices is as high as 100.0%, and the specificity is 92.3%. In the identification of moderate and severe OSA (AHI ≥ 15 times/h), the sensitivity and specificity both reached 100.0%. Conclusion: The enhanced wearable sleep monitoring device has a highly consistent diagnostic efficiency with the standard system in clinical screening and severity grading of OSA. It can effectively improve the convenience of home monitoring and patient compliance while ensuring high sensitivity and can be used as a reliable clinical tool for early screening, graded diagnosis and treatment and chronic disease management of OSA.