NAPS2 Polysomnogram Core

NAPS2 多导睡眠图核心

• 批准号: 10457861
• 负责人: Erik Kent St. Louis
• 金额: $ 45.74万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10457861
• 关键词: American; Behavior; Biological Markers; Characteristics; Classification; Clinical; Clinical Data; Clinical Trials; Collection; Counseling; Data; Data Analyses; Data Collection; Data Set; Dementia with Lewy Bodies; Development; Diagnosis; Diagnostic; Dreams; Electroencephalography; Electrophysiology (science); Future; Goals; Gold; Home; Individual; Injury; Investigation; Laboratories; Machine Learning; Manuals; Measures; Methodology; Methods; Multicenter Studies; Multiple System Atrophy; Muscle; Neurodegenerative Disorders; Parkinson Disease; Participant; Pathology; Pathway Analysis; Patients; Pattern; Polysomnography; Process; REM Sleep; REM Sleep Behavior Disorder; Research; Research Personnel; Resources; Scoring Method; Selection Bias; Signal Transduction; Site; Sleep; Sleep Stages; Standardization; Testing; Time; United States National Institutes of Health; Validation; Video Recording; Visual; base; cohort; data management; data sharing; machine learning method; neurophysiology; novel; prognostic; prospective; repository; signal processing; sleep behavior; symptom treatment; synuclein; synucleinopathy

ABSTRACT: NAPS2 POLYSOMNOGRAM (PSG) CORE Rapid eye movement (REM) sleep behavior disorder (RBD) is characterized by dream enactment behavior, and its neurophysiologic signature during polysomnography (PSG) is REM sleep without atonia (RSWA). RBD usually represents a prodromal synucleinopathy, and increasing evidence suggests RSWA may serve as a biomarker of synucleinopathy-related pathology: RSWA increases over time, predicts phenoconversion to overt synucleinopathy, and correlates with clinical measures of synuclein pathology. However, due to lack of data from prospective, multi-center studies, there are no established RSWA values that can be used as a biomarker. The North American Prodromal Synucleinopathy (NAPS) Consortium for RBD was established in 2018 to enable multicenter research in RBD with the long-term goal of promoting development of neuroprotective clinical trials in RBD. We successfully collected retrospective PSG data from across 10 NAPS Sites. These preliminary data demonstrate feasibility of analyzing RSWA and other neurophysiologic signals acquired during PSG across multiple sites and platforms. In NAPS Stage 2, or NAPS2, we will build on our current large cohort of participants with RBD, and will collect research-grade PSG data from >300 RBD participants twice, two years apart, and once from matched Control participants. The NAPS2 PSG Core will oversee collection, analysis, and distribution of PSG data, with the overall goal of developing RSWA as a biomarker for synucleinopathies for application in future clinical trials. The NAPS2 PSG Core will standardize and harmonize PSG data collection across NAPS2 Sites. The PSG Core will quantify REM sleep without atonia (RSWA) using a variety of methods, and determine the degree of within-individual progression in RSWA over time. The PSG Core will provide key RSWA metrics to the NAPS2 Project for assessment of RSWA as a biomarker to predict phenoconversion and track progression of synuclein-related pathology. All PSG data will be shared publicly through the NIH-sponsored National Sleep Research Resource (NSRR), a national repository of sleep-based electrophysiologic data. We will coordinate with the NAPS2 Data Management and Statistical (DMS) Core to develop signal processing and novel machine learning methods for application to electroencephalography and other neurophysiological signals recorded during PSG. The PSG Core will explore the feasibility and reliability of alternative, non-laboratory methods for home-based PSG. The NAPS2 PSG Core will enable development of RSWA as a biomarker for prodromal synucleinopathies, promote research with PSG-derived neurophysiologic signals, and advance technological improvements in PSG data collection and analysis.

摘要：NAPS2多克隆抗体（PSG）核心 快速眼动（REM）睡眠行为障碍（RBD）的特征是做梦行为， 并且其在多导睡眠图（PSG）期间的神经生理学特征是无张力的REM睡眠（RSWA）。RBD 通常代表前驱期突触核蛋白病，越来越多的证据表明RSWA可能是一种 突触核蛋白病相关病理学的生物标志物：RSWA随时间增加，预测表型转化为显性 突触核蛋白病，并与突触核蛋白病理学的临床测量相关。然而，由于缺乏数据， 从前瞻性、多中心研究来看，没有确定的RSWA值可用作 生物标记物。北美前驱突触核蛋白病（NAPS）联盟为RBD， 成立于2018年，旨在实现RBD的多中心研究，其长期目标是促进发展 在RBD进行的神经保护临床试验。我们成功地收集了来自10个国家的回顾性PSG数据， NAPS网站。这些初步数据证明了分析RSWA和其他神经生理学指标的可行性。 PSG期间跨多个站点和平台采集的信号。在NAPS第二阶段，或NAPS2，我们将建立在 我们目前的大型RBD参与者队列，并将从> 300 RBD收集研究级PSG数据 参与者两次，间隔两年，一次来自匹配的对照组参与者。NAPS2 PSG核心将 监督PSG数据的收集、分析和分发，总体目标是将RSWA发展为一个 用于将来临床试验的突触核蛋白病的生物标志物。NAPS 2 PSG核心将标准化 并协调NAPS 2研究中心的PSG数据收集。PSG核心将量化REM睡眠， 使用各种方法检测肌张力缺乏（RSWA），并确定RSWA中个体内进展的程度 随着时间PSG核心将为NAPS2项目提供关键的RSWA指标，以评估RSWA， 生物标志物来预测表型转化和跟踪突触核蛋白相关病理学的进展。所有PSG数据将 通过NIH赞助的国家睡眠研究资源（NSRR）公开共享， 基于睡眠的电生理学数据库。我们将与NAPS2数据管理部门协调， 统计（DMS）核心开发信号处理和新的机器学习方法， PSG期间记录的脑电图和其他神经生理信号。PSG核心将 探索替代的、非实验室方法用于家庭PSG的可行性和可靠性。NAPS2 PSG核心将使RSWA作为前驱突触核蛋白病的生物标志物的开发成为可能， 研究PSG衍生的神经生理信号，并推进PSG数据的技术改进 收集和分析。