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MediByte® 型 3 便携式监测仪与多导睡眠图筛查阻塞性睡眠呼吸暂停的对比验证。

Validation of the MediByte® type 3 portable monitor compared with polysomnography for screening of obstructive sleep apnea.

机构信息

Sleep Disorders Laboratory, Kingston General Hospital and Queen's University, Department of Medicine, Ontario.

出版信息

Can Respir J. 2011 May-Jun;18(3):137-43. doi: 10.1155/2011/760958.

Abstract

BACKGROUND

Portable monitors are increasingly being used as a diagnostic screening tool for obstructive sleep apnea (OSA), and in-laboratory validation of these devices with polysomnography (PSG) is required.

OBJECTIVE

To assess the reliability of the MediByte (Braebon Medical Corporation, Canada) type 3 screening device compared with overnight PSG.

METHODS

To cover a range of OSA severity, a consecutive series of patients wore the screening device while simultaneously undergoing PSG. Data acquired from the screener and PSG were blinded and scored separately. The number of apneas and hypopneas per hour were calculated using recording time (respiratory disturbance index [RDI]) for the MediByte device, and sleep time (apnea-hypopnea index [AHI]) for PSG.

RESULTS

Data from 73 patients with a mean age of 53 years and body mass index of 32.2 kg⁄m2 showed high measurement association between the RDI and AHI, with a Pearson correlation of 0.92, accounting for 85% of the variance. Based on Bland-Altman measurement agreement, the mean difference between the RDI and AHI (-5.9±11.2 events⁄h) indicated screener under-reporting. For an AHI of greater than 15 events⁄h, the sensitivity and specificity of the screener was 80% and 97%, respectively; for an AHI of greater than 30 events⁄h, the positive predictive value was 100%, while the negative predictive value was 88%.

CONCLUSION

The MediByte device accurately identified patients without OSA and had a high sensitivity for moderate-to-severe OSA.

摘要

背景

便携式监测仪越来越多地被用作阻塞性睡眠呼吸暂停(OSA)的诊断筛查工具,需要对这些设备进行与多导睡眠图(PSG)的实验室验证。

目的

评估 MediByte(加拿大 Braebon Medical Corporation)3 型筛查设备与整夜 PSG 的可靠性。

方法

为了涵盖 OSA 严重程度的范围,连续系列的患者在同时进行 PSG 的同时佩戴筛查设备。从筛查器和 PSG 获得的数据被盲法记录并单独评分。使用记录时间(呼吸紊乱指数 [RDI])计算筛查器的每小时呼吸暂停和低通气次数,使用 PSG 的睡眠时间(呼吸暂停低通气指数 [AHI])计算 PSG 的每小时呼吸暂停和低通气次数。

结果

数据来自 73 名平均年龄为 53 岁和体重指数为 32.2 kg/m2 的患者,RDI 和 AHI 之间的测量相关性很高,Pearson 相关系数为 0.92,占方差的 85%。基于 Bland-Altman 测量一致性,RDI 和 AHI 之间的平均差异(-5.9±11.2 次/小时)表明筛查器的报告不足。对于 AHI 大于 15 次/小时,筛查器的敏感性和特异性分别为 80%和 97%;对于 AHI 大于 30 次/小时,筛查器的阳性预测值为 100%,而阴性预测值为 88%。

结论

MediByte 设备准确地识别了没有 OSA 的患者,并且对中重度 OSA 具有高敏感性。

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