Li C Y, Wang W, Huang W J, Xu H H, Yi H L, Guan J, Li G, Yin S K
Department of Otorhinolaryngology Head and Neck Surgery, Shanghai JiaoTong University school of medicine Affiliated Sixth People's Hospital, Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai 200233, China.
Department of Electronic Engineering, Tsinghua University, Beijing 100084, China.
Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Aug 7;59(8):857-863. doi: 10.3760/cma.j.cn115330-20231204-00267.
This study evaluates the agreement between a new low-load sleep monitoring system, QSA600, based on millimeter-wave radar technology, and polysomnography (PSG) in diagnosing obstructive sleep apnea (OSA). A total of 155 subjects were recruited for a parallel agreement study in the sleep laboratory of the Department of Otorhinolaryngology Head and Neck Surgery at Shanghai Sixth People's Hospital from July to September 2023. The subjects underwent simultaneous monitoring with both PSG and the QSA600 system. One hundred and forty-five subjects consisting of 75 males and 70 females included in the final analysis, with an average age of (35.30±12.41) years, an average height of (168.23±8.08) cm, and an average weight of (68.28±13.74) kg. The subjects were divided into four groups based on the apnea-hypopnea index (AHI): <5.0 events/h (non-OSA group, 39 cases), ≥5.0-<15.0 events/h (mild OSA group, 47 cases), ≥15.0-<30.0 events/h (moderate OSA group, 25 cases), and≥30.0 events/h (severe OSA group, 34 cases). Intraclass correlation coefficients (ICC), Pearson correlation coefficients (), and Bland-Altman analysis were employed to assess the agreement between the two monitoring techniques regarding AHI and other parameters. Sensitivity and specificity of the QSA600 in diagnosing OSA were evaluated at different AHI thresholds. Statistical analyses were conducted using MATLAB R2022a. Using AHI 5 events/h, 15 events/h and 30 events/h as thresholds, the sensitivity for diagnosing mild, moderate, and severe OSA was 88.68%, 89.83% and 97.06%, respectively. The specificity was 94.87%, 98.84% and 99.10%, respectively. The areas under the receiver operating characteristic (ROC) curve was 0.973 4, 0.990 9 and 0.999 5, respectively. The comparison of key indicators between QSA600 and PSG diagnostic results revealed:a Pearson correlation coefficient of 0.987 2(<0.001) between the AHI measurement values. The mean difference between the Bland-Altman measurement values of the two was -1.43(95%:-8.74-5.88) events/h and the ICC between the two was 0.985 0(95%: 0.975 4-0.990 4). As a new low-load sleep monitoring system, QSA600 demonstrates high concordance with traditional PSG in diagnosing OSA and stratifying its severity, which has promising potential for clinical application. (Clinical trial registration number: NCT06038006).
本研究评估了一种基于毫米波雷达技术的新型低负荷睡眠监测系统QSA600与多导睡眠图（PSG）在诊断阻塞性睡眠呼吸暂停（OSA）方面的一致性。2023年7月至9月，在上海第六人民医院耳鼻咽喉头颈外科睡眠实验室招募了155名受试者进行平行一致性研究。受试者同时接受PSG和QSA600系统的监测。最终分析纳入145名受试者，其中男性75名，女性70名，平均年龄为（35.30±12.41）岁，平均身高为（168.23±8.08）cm，平均体重为（68.28±13.74）kg。根据呼吸暂停低通气指数（AHI）将受试者分为四组：<5.0次/小时（非OSA组，39例）、≥5.0-<15.0次/小时（轻度OSA组，47例）、≥15.0-<30.0次/小时（中度OSA组，25例）和≥30.0次/小时（重度OSA组，34例）。采用组内相关系数（ICC）、Pearson相关系数（）和Bland-Altman分析来评估两种监测技术在AHI和其他参数方面的一致性。在不同的AHI阈值下评估QSA600诊断OSA的敏感性和特异性。使用MATLAB R2022a进行统计分析。以AHI 5次/小时、15次/小时和30次/小时为阈值，诊断轻度、中度和重度OSA的敏感性分别为88.68%、89.83%和97.06%。特异性分别为94.87%、98.84%和99.10%。受试者工作特征（ROC）曲线下面积分别为0.973 4、0.990 9和0.999 5。QSA600与PSG诊断结果的关键指标比较显示：AHI测量值之间的Pearson相关系数为0.987 2（<0.001）。两者Bland-Altman测量值的平均差异为-1.43（95%：-8.74-5.88）次/小时，两者之间的ICC为0.985 0（95%：0.975 4-0.990 4）。作为一种新型低负荷睡眠监测系统，QSA600在诊断OSA及其严重程度分层方面与传统PSG具有高度一致性，具有良好的临床应用潜力。（临床试验注册号：NCT06038006）
