NCT06582121招募中不适用
Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 457
- 试验地点
- 6
- 主要终点
- Polysomnography to compare sleep efficiency
研究概览
简要总结
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson's disease (SOMPARK)
详细描述
Sleep disturbances are common and understudied in established or prodromal Parkinson's disease. The purpose of this study is to systematically and comprehensively determine the clinical characteristics and electrophysiologic patterns of the major sleep disorders in PD and isolated RBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Common to all groups:
- •Age superior 18 years
- •Patients who have received complete information about the study from an investigator and who fully consent to participate.
- •For Parkinson Disease (PD):
- •Patients followed for PD diagnosed according to international criteria for the diagnosis of PD (MDS criteria),
- •A MoCA score greater than 20/30
- •No treatment with deep brain stimulation.
- •For REM Sleep Behavior Disorder (RBD):
- •Diagnosis of RBD according to ICSD-3 criteria: presence on polysomnography of an abnormal elevation of muscle tone during REM sleep (more than 18% of REM sleep without chin atonia) and/or the presence of REM sleep behaviors on video-polysomnography,
- •Absence of progressive neurodegenerative pathology: absence of diagnostic criteria for PD, multiple system atrophy, or Lewy body dementia.
- •For healthy controls:
- •- No neurological or psychiatric disease
排除标准
- •Common to all groups:
- •Pregnant or breastfeeding women
- •Subjects under guardianship/conservatorship
- •Persons deprived of liberty.
研究组 & 干预措施
Participants
Experimental
Study of the sleep with polysomnography during a 2-days stay in hospital. Other exam will be done during the 2 days.
干预措施: Polysomnography (Other)
结局指标
主要结局
Polysomnography to compare sleep efficiency
时间窗: 25 months
Using polysomnography to compare sleep efficiency in the 3 study populations during the first night
次要结局
未报告次要终点
研究者
研究点 (6)
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