Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effect of pimavanserin on sleep fragmentation
研究概览
简要总结
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.
详细描述
This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions.
Patients will complete a Screening Visit to assess eligibility to participate in the study.
For more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pimavanserin (Nuplazid)
Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems
干预措施: Pimavanserin (Drug)
结局指标
主要结局
Effect of pimavanserin on sleep fragmentation
时间窗: 6 weeks
Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography
次要结局
- Effect of pimavanserin on sleep efficiency(6 weeks)
- Effect of pimavanserin on subjective measures of sleep(6 weeks)
- Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder(6 weeks)
- Effect of pimavanserin on time in each sleep stage(6 weeks)
- Effect of pimavanserin on subjective measure of REM Sleep behavior disorder(6 weeks)
- Effect of pimavanserin on sleep latency(6 weeks)
- Effect of pimavanserin on total sleep time(6 weeks)
- Effect of pimavanserin on subjective measures of fatigue(6 weeks)