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临床试验/NCT03660982
NCT03660982Unknown不适用

Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder: a Case-control Family Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
The prevalence rate of probable RBD among first degree relatives of RBD probands

研究概览

简要总结

In this cohort study, the investigators aim to study the familial aggregation of REM sleep behavior disorder (RBD) and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.

详细描述

REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Previous case-control studies and prospective studies have documented the progression of α-synucleinopathy neurodegeneration in relation to RBD and have identified some biomarkers of predicting neurodegeneration in patients with iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, these biomarkers might precede the onset of RBD, as a result, searching for biomarkers for the neurodegeneration before RBD onset is helpful to map the progression of neurodegeneration. In this regard, the investigators aim to study the familial aggregation of RBD and its core features, and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese aged 40 or above;
  • Being capable of giving informed consent for participation of the study;
  • Sex matched between relatives from probands and controls.

排除标准

  • Aged 39 or below;
  • Not capable of giving informed consent for participation of the study

结局指标

主要结局

The prevalence rate of probable RBD among first degree relatives of RBD probands

时间窗: 15 minutes

The prevalence rate of probable RBD based on the self-reported/proxy-reported RBD symptoms in RBDQ-HK among first degree relatives of RBD probands in comparison to that of first degree relatives of controls.

The weighted prevalence rate of confirmed RBD among first degree relatives of RBD probands.

时间窗: one night (8 hours)

The weighted prevalence rate of first degree relatives meeting full ICSD-II2 diagnostic criteria for RBD confirmed by clinical history and vPSG.

次要结局

  • Other biomarkers of RBD in the first degree relatives of RBD patients.(2 hours)
  • The percentage of REM-related EMG activity (REMREEA)(one night (8 hours))
  • Significant motor activity(one night (8 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Zhang Jihui

Assistant professor

Chinese University of Hong Kong

研究点 (1)

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