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临床试验/NCT04441697
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

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

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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