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SOMNIA 项目方案:一项旨在为高级临床睡眠监测创建神经生理学数据库的观察性研究。

Protocol of the SOMNIA project: an observational study to create a neurophysiological database for advanced clinical sleep monitoring.

机构信息

Electrical Engineering, Technische Universiteit Eindhoven, Eindhoven, The Netherlands

Center for Sleep Medicine, Kempenhaeghe Foundation, Heeze, Noord Brabant, The Netherlands.

出版信息

BMJ Open. 2019 Nov 25;9(11):e030996. doi: 10.1136/bmjopen-2019-030996.

DOI:10.1136/bmjopen-2019-030996
PMID:31772091
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6886950/
Abstract

INTRODUCTION

Polysomnography (PSG) is the primary tool for sleep monitoring and the diagnosis of sleep disorders. Recent advances in signal analysis make it possible to reveal more information from this rich data source. Furthermore, many innovative sleep monitoring techniques are being developed that are less obtrusive, easier to use over long time periods and in the home situation. Here, we describe the methods of the Sleep and Obstructive Sleep Apnoea Monitoring with Non-Invasive Applications (SOMNIA) project, yielding a database combining clinical PSG with advanced unobtrusive sleep monitoring modalities in a large cohort of patients with various sleep disorders. The SOMNIA database will facilitate the validation and assessment of the diagnostic value of the new techniques, as well as the development of additional indices and biomarkers derived from new and/or traditional sleep monitoring methods.

METHODS AND ANALYSIS

We aim to include at least 2100 subjects (both adults and children) with a variety of sleep disorders who undergo a PSG as part of standard clinical care in a dedicated sleep centre. Full-video PSG will be performed according to the standards of the American Academy of Sleep Medicine. Each recording will be supplemented with one or more new monitoring systems, including wrist-worn photoplethysmography and actigraphy, pressure sensing mattresses, multimicrophone recording of respiratory sounds including snoring, suprasternal pressure monitoring and multielectrode electromyography of the diaphragm.

ETHICS AND DISSEMINATION

The study was reviewed by the medical ethical committee of the Maxima Medical Center (Eindhoven, the Netherlands, File no: N16.074). All subjects provide informed consent before participation.The SOMNIA database is built to facilitate future research in sleep medicine. Data from the completed SOMNIA database will be made available for collaboration with researchers outside the institute.

摘要

简介

多导睡眠图(PSG)是睡眠监测和睡眠障碍诊断的主要工具。信号分析的最新进展使得从这个丰富的数据源中揭示更多信息成为可能。此外,许多创新的睡眠监测技术正在开发中,这些技术在不那么引人注目的情况下,在长时间内和家庭环境中使用起来更容易。在这里,我们描述了睡眠和阻塞性睡眠呼吸暂停监测的非侵入性应用(SOMNIA)项目的方法,该项目在一个有各种睡眠障碍的大患者队列中,将结合临床 PSG 与先进的非侵入性睡眠监测方式的数据库。SOMNIA 数据库将有助于验证和评估新技术的诊断价值,以及开发源自新的和/或传统睡眠监测方法的其他指数和生物标志物。

方法和分析

我们的目标是纳入至少 2100 名患有各种睡眠障碍的患者(包括成人和儿童),这些患者在专门的睡眠中心进行 PSG 作为标准临床护理的一部分。全视频 PSG 将按照美国睡眠医学学会的标准进行。每个记录将辅以一个或多个新的监测系统,包括腕戴光体积描记法和活动记录仪、压力感应床垫、包括打鼾在内的呼吸声音的多麦克风记录、胸骨上压力监测和膈多电极肌电图。

伦理和传播

该研究已由 Maxima 医疗中心的医学伦理委员会(荷兰埃因霍温,文件号:N16.074)审查。所有受试者在参与前均提供知情同意。SOMNIA 数据库旨在促进睡眠医学的未来研究。完成的 SOMNIA 数据库的数据将可供机构外的研究人员合作使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cdc0/6886950/01440dc30c2d/bmjopen-2019-030996f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cdc0/6886950/0e6284192084/bmjopen-2019-030996f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cdc0/6886950/01440dc30c2d/bmjopen-2019-030996f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cdc0/6886950/0e6284192084/bmjopen-2019-030996f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cdc0/6886950/01440dc30c2d/bmjopen-2019-030996f02.jpg

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