新型雷达设备诊断阻塞性睡眠呼吸暂停:一项评价与多导睡眠监测等效性的平行对照研究
Diagnosis of obstructive sleep apnea by a new radar device:a parallel controlled study evaluating agreement with polysomnographic monitoring
李晨洋 1王威 2黄炜峻 1许华俊 1易红良 1关建 1李刚 2殷善开1
作者信息
- 1. 上海交通大学医学院附属第六人民医院耳鼻咽喉头颈外科 上海市睡眠呼吸障碍疾病重点实验室,上海 200233
- 2. 清华大学电子工程系,北京 100084
- 折叠
摘要
目的 评价基于毫米波雷达的低负荷新型睡眠监测系统QSA600与多导睡眠监测(polysomnography,PSG)在诊断阻塞性睡眠呼吸暂停(obstructive sleep apnea,OSA)的一致性.方法 2023年7月至9月招募155名受试者,在上海市第六人民医院耳鼻咽喉头颈外科睡眠实验室同时接受PSG和QSA600监测,145名受试者纳入最终分析,其中男75例,女70例,年龄为(35.30±12.41)岁,身高为(168.23±8.08)cm,体重为(68.28±13.74)kg,进行一致性平行对照研究.以呼吸暂停低通气指数(apneahypopnea index,AHI)将受试者分为4组:＜5.0 次/h(NOSA组,39例),≥5.0次/h～＜15.0 次/h(轻度OSA组,47例),≥ 15.0次/h～＜30.0次/h(中度OSA组,25例),≥30.0次/h(重度OSA组,34例).采用组内相关系数(intraclass correlation coefficients,ICC)、Pearson相关系数(r)和 Bland-Altman检验来评价 2种监测技术AHI等指标的一致性.根据AHI不同阈值,检验QSA600的诊断灵敏度、特异度.采用MATLAB R2022a进行统计学分析.结果 分别以AHI5次/h、15次/h、30次/h为阈值,对轻度、中度、重度OSA诊断的灵敏度分别为88.68％、89.83％、97.06％,特异度分别为94.87％、98.84％、99.10％,受试者工作特征(receiver operating characteristic,ROC)曲线下面积分别为 0.973 4、0.990 9、0.999 5.QSA600与PSG诊断结果的关键指标(AHI)的一致性对比结果:二者Pearson相关性为0.987 2(P＜0.001);二者 Bland-Altman测定差值均数为-1.43 次/h[95％置信区间(confidence interval,CI)为-8.74～5.88];二者ICC为0.985 0(95％CI为0.975 4～0.990 4).结论 作为低负荷新型睡眠监测系统,QSA600在诊断OSA及不同严重程度OSA分级方面与PSG表现出很高的一致性,有较好临床应用前景.
Abstract
Objective 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).Methods 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(168.2 3±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(r),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.Results 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(P＜0.001)between the AHI measurement values.The mean difference between the Bland-Altman measurement values of the two was-1.43(95％CI:-8.74-5.88)events/h and the ICC between the two was 0.985 0(95％CI:0.975 4-0.990 4).Conclusions 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)
关键词
阻塞性睡眠呼吸暂停/雷达设备/多导睡眠监测/一致性Key words
Obstructive sleep apnea/Radar device/Polysomnography/Agreement引用本文复制引用
基金项目
科技创新2030项目(2021ZD0201900)
上海市中医药三年行动计划(2021-2023)(ZY2021-2023-0205-04)
上海交通大学医工(理)交叉基金(YG2023LC11)
国家杰出青年科学基金(61925106)
清华大学-佛山先进制造研究院电子信息器件与系统联合研究中心项目(20202910574)
出版年
2024
NETL
NSTL
万方数据