NCT04441697Unknown不适用
Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean sleep latency
研究概览
简要总结
Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with Parkinson's disease and motor fluctuations
- •and indicated for a continuous dopaminergic delivery device or deep brain stimulation
排除标准
- •age < 18 years
- •refusal for the continuous dopaminergic delivery device or deep brain stimulation
- •wake-promoting drugs intake
- •refusal to participate
- •legal protection
- •uncontrolled sleep apnea
结局指标
主要结局
Mean sleep latency
时间窗: 12 months after continous antiparkinsonian treatment
Algebric mean (in minutes) of the sleep latency for the four experimental naps
次要结局
未报告次要终点
研究者
研究点 (1)
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