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临床试验/NCT03671798
NCT03671798Unknown不适用

Establish a National Registry to Search for the Risk Factors, Etiology, and Neurodegenerative Progression of REM Sleep Behavior Disorder

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,000
试验地点
1
主要终点
Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder.

研究概览

简要总结

In this proposed study, the investigators aim to build up a large cohort of Rapid eye movement sleep behavior disorder (RBD) to study the etiology and risk factors of neurodegeneration.

详细描述

REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Accumulating evidence suggests that RBD is implicated as an integral part of disease progress of α-synucleinopathy neurodegeneration, such as Parkinson's disease (PD) and dementia with Lewy bodies.Previous studies have identified a series of neurocognitive, autonomic, clinical and neurobiological markers for neurodegeneration in iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, the prevalence rate of RBD was relatively low and most of the RBD studies only have 100 or below cases. and there might be ethic differences in RBD which indicates that the findings from western countries might not be applicable to Chinese. In these regards, the investigators aimed to build up a large cohort of Rapid eye movement sleep behavior disorder (RBD) to study the etiology and risk factors of neurodegeneration.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Case: According to the ICSD-3 for the diagnosis of RBD
  • Sleep talking or complex movement during sleep;
  • Such movement was recorded by video PSG (AV-PSG) during REM sleep or according to history the movements were occurred during REM;
  • REM sleep without atonia (RWA) during PSG monitoring;
  • This abnormal phenomenon cannot be explained by other sleep disorder, psychiatric disease, drug or substance abuse.
  • Control: Age and gender matched with consent
  • No RBD symptoms and PSG characteristics;
  • No neurological symptoms or diseases, MRI scan will be employed to exclude brain pathology;
  • No narcolepsy or hypersomnia, ruled out by multiple sleep latency test;
  • No history of mental illnesses or use of antidepressants.

排除标准

  • Subjects who refused to join the cohort.

结局指标

主要结局

Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder.

时间窗: 1 hour

Risk factors for neurodegenerative diseases were investigated in rapid eye movement sleep behavior disorder by questionnaires, including general information, life history, occupational history and family history.

Changes of REM-related EMG activity (REMREEA) and motor activity in rapid eye movement sleep behavior disorder.

时间窗: Baseline and biennial follow-up, up to 20 years

The percentage of REM-related EMG activity (REMREEA) is the most reliable and valid marker in differentiating patients with RBD from normal controls. Both REMREEA and significant motor activity were recorded by video-polysomnography in rapid eye movement sleep behavior disorder.

Changes of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder.

时间窗: Baseline and biennial follow-up, up to 20 years

Based on the large cohort of RBD, the investigators aim to study the etiology and the progression of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder by clinical assessment, including MoCA, olfactory dysfunction, color vision deficit and so on.

Changes of autonomic dysfunctions for neurodegenerative diseases in rapid eye movement sleep behavior disorder.

时间窗: Baseline and biennial follow-up, up to 20 years

Autonomic dysfunctions are also biomarkers for neurodegenerative diseases, the investigators aim to observe the changes of autonomic dysfunctions, including constipation, orthostatic hypotension and so on.

次要结局

未报告次要终点

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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