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临床试验/NCT00070928
NCT00070928已完成2 期

Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2000年9月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
2

研究概览

简要总结

The purpose of this trial is to test the short-term effectiveness of valerian, a medicinal herb, to improve sleep in patients with Parkinson's disease (PD).

详细描述

Patients with PD have exceptionally poor sleep. Sleep in patients with PD is characterized by excessive activity in surface electromyographic (EMG) recordings from many different muscle groups. Despite sleep disturbances, approximately 50% of patients experience a transient (1 to 3 hour) reduction in waking motor symptoms upon arising in the morning. This effect has been termed Sleep Benefit. This study will evaluate the effects of valerian, a medicinal herb, on the sleep of patients with PD.

This is a 17 day study where participants will be evaluated by polysomnography on days one, two, three, sixteen and seventeen.. Polysomnographic measurements will include customary variables such as total sleep time, sleep efficiency, and sleep latency, as well as EMG measures of periodic and isolated muscle activity during sleep. Participants will be required to keep a detailed sleep log of their self reported sleep characteristics across the entire 17 study nights. Outcomes will include measures of both nocturnal sleep and waking motor function. Assessments of motor function will be made the morning immediately following Nights 3 and 17 in order to test for improvement related to improved sleep. On the morning following Night 17, participants are provided with a one-week supply of valerian in an Open Label extension. Participants are provided an additional Sleep Log for this week and asked to return the Sleep Log when they complete the Open Label phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

研究点 (2)

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