基于无线贴片的多导睡眠图系统的临床验证

Clinical validation of a wireless patch-based polysomnography system.

作者信息

Viniol Christian, Galetke Wolfgang, Woehrle Holger, Nilius Georg, Schöbel Christoph, Randerath Winfried, Leiter James, Canisius Sebastian, Schneider Hartmut

机构信息

Department of Pneumology, Universitätsklinikum Gießen und Marburg GmbH, Marburg, Germany.

VAMED Klinik Hagen-Ambrock, Hagen, Germany.

出版信息

J Clin Sleep Med. 2025 May 1;21(5):813-823. doi: 10.5664/jcsm.11524.

DOI:10.5664/jcsm.11524

PMID:39773950

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12048320/

Abstract

STUDY OBJECTIVES

Onera Health has developed the first wireless, patch-based, type-II polysomnography (PSG) system, the Onera Sleep Test System, to allow studies to be performed unattended at the patient's home or in any bed at a medical facility. The goal of this multicenter study was to validate data collected from the patch-based PSG to a traditional PSG for sleep staging and apnea-hypopnea index.

METHODS

Simultaneous traditional PSG and patch-based PSG study data were obtained in a sleep laboratory from 206 participants with a suspected sleep disorder recruited from 7 clinical sites. Blinded, randomized scoring of the traditional PSG and patch-based PSG recordings was completed according to (Version 2.6) criteria by 3 independent scorers.

RESULTS

Concordance correlation coefficients were high between the patch-based device and traditional PSG across essential sleep and respiratory variables-total sleep time (.87); wake (.84); non-rapid eye movement (REM) (.80); non-REM sleep stage 1 (N1) (.72); non-REM sleep stage 2 (N2) (.71); non-REM sleep stage 3 (N3) (.64); REM (.80); and apnea-hypopnea index (AHI) (.94). There was substantial agreement between epoch sleep staging scored on the patch-based device and traditional PSG (average Cohen's kappa of 0.62 ± 0.13 across all scorers).

CONCLUSIONS

The patch-based type-II PSG had a similar performance on sleep staging and respiratory variables when compared to traditional PSG, thus making it possible to use the patch-based PSG for a routine PSG study. These results open the possibility of performing unattended PSG studies efficiently and accurately outside the sleep laboratory improving access to high quality sleep assessments for patients with sleep disorders.

CLINICAL TRIAL REGISTRATION

Registry: ClinicalTrials.gov; Name: Validation Study of a Patch-based PSG System; URL: https://clinicaltrials.gov/study/NCT05310708; Identifier: NCT05310708.

CITATION

Viniol C, Galetke W, Woehrle H, et al. Clinical validation of a wireless patch-based polysomnography system. . 2025;21(5):813-823.

摘要

研究目的

Onera Health公司开发了首款基于贴片的无线II型多导睡眠图（PSG）系统——Onera睡眠测试系统，以便能够在患者家中或医疗机构的任何床上无人值守地进行研究。这项多中心研究的目的是验证从基于贴片的PSG收集的数据与传统PSG在睡眠分期和呼吸暂停低通气指数方面的数据。

方法

在睡眠实验室中，从7个临床地点招募的206名疑似睡眠障碍患者同时获取了传统PSG和基于贴片的PSG研究数据。3名独立评分员根据（第2.6版）标准对传统PSG和基于贴片的PSG记录进行了盲法、随机评分。

结果

在基本睡眠和呼吸变量方面，基于贴片的设备与传统PSG之间的一致性相关系数很高——总睡眠时间（.87）；清醒（.84）；非快速眼动（REM）（.80）；非快速眼动睡眠1期（N1）（.72）；非快速眼动睡眠2期（N2）（.71）；非快速眼动睡眠3期（N3）（.64）；快速眼动（.80）；以及呼吸暂停低通气指数（AHI）（.94）。基于贴片的设备和传统PSG对各时段睡眠分期的评分之间存在高度一致性（所有评分员平均Cohen's kappa为0.62±0.13）。