一种具有高精度的新型设备（SD-101），用于筛查睡眠呼吸暂停低通气综合征。

A novel device (SD-101) with high accuracy for screening sleep apnoea-hypopnoea syndrome.

机构信息

First Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Nagano 390-8621, Japan.

出版信息

Respirology. 2009 Nov;14(8):1143-50. doi: 10.1111/j.1440-1843.2009.01627.x. Epub 2009 Oct 8.

DOI:10.1111/j.1440-1843.2009.01627.x

PMID:19818056

Abstract

BACKGROUND AND OBJECTIVE

The SD-101 is a non-restrictive, sheet-like medical device with an array of pressure sensors, to detect sleep-disordered breathing by sensing gravitational alterations in the body corresponding to respiratory movements. This study evaluated the accuracy of the SD-101 for screening sleep apnoea-hypopnoea syndrome (SAHS) by comparison with polysomnography.

METHODS

Nocturnal polysomnography and SD-101 monitoring were conducted simultaneously and compared in 201 patients with suspected SAHS (suspected SAHS group) and 165 male employees of a transport company (screening group).

RESULTS

Polysomnography revealed an AHI of <5, 5 < or = AHI < 15, 15 < or = AHI < 30, 30 < or = AHI < 60 and AHI > or = 60 events/h in 39, 35, 38, 68 and 21 subjects in the suspected SAHS group and 103, 34, 12, 12 and four subjects in the screening group, respectively. Central SAHS and obstructive SAHS were subsequently diagnosed in 11 (5.5%) and 135 (67.2%) of subjects in the suspected SAHS group and five (3.0%) and 39 (23.6%) of subjects in the screening group, respectively. Significant correlations were apparent between AHI and the respiratory disturbance index (RDI) measured with the SD-101 in both the suspected SAHS group (r = 0.88) and screening group (r = 0.92). Receiver operating characteristic curve analysis revealed 89.5% sensitivity and 85.8% specificity in identifying SAHS, using an RDI of 14.0 events/h.

CONCLUSIONS

These findings suggest that the SD-101 is a useful device for screening SAHS.

摘要

背景和目的

SD-101 是非限制性的片状医疗设备，配有压力传感器阵列，通过感测与呼吸运动相对应的身体的重力变化来检测睡眠呼吸障碍。本研究通过与多导睡眠图（PSG）比较，评估了 SD-101 筛查睡眠呼吸暂停低通气综合征（SAHS）的准确性。

方法

对 201 例疑似 SAHS 患者（疑似 SAHS 组）和 165 名运输公司男性员工（筛查组）同时进行夜间多导睡眠图和 SD-101 监测，并进行比较。

结果

多导睡眠图显示，疑似 SAHS 组中 39 例、35 例、38 例、68 例和 21 例患者的呼吸暂停低通气指数（AHI）分别<5、5<或=AHI<15、15<或=AHI<30、30<或=AHI<60 和 AHI>或=60 事件/小时，筛查组中 103 例、34 例、12 例、12 例和 4 例患者的 AHI 分别为<5、5<或=AHI<15、15<或=AHI<30、30<或=AHI<60 和 AHI>或=60 事件/小时。疑似 SAHS 组中 11 例（5.5%）和 135 例（67.2%）患者分别诊断为中枢性 SAHS 和阻塞性 SAHS，筛查组中 5 例（3.0%）和 39 例（23.6%）患者分别诊断为中枢性 SAHS 和阻塞性 SAHS。在疑似 SAHS 组（r=0.88）和筛查组（r=0.92）中，SD-101 测量的 AHI 与呼吸紊乱指数（RDI）之间均存在显著相关性。受试者工作特征曲线分析显示，当 RDI 为 14.0 事件/小时时，SD-101 诊断 SAHS 的敏感性为 89.5%，特异性为 85.8%。