Effect of DBS on Sleep Architecture in Patients With Movement Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Sleep Efficiency
研究概览
简要总结
The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after the procedure. The cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with DBS treatment of the motor symptoms of PD, tremor, or dystonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.
- •Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
- •Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5) at the subject's baseline pre-surgical evaluation.
排除标准
- •Known narcolepsy
- •Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
- •Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with CPAP, they can re-start the study.
研究组 & 干预措施
DBS on
baseline settings
干预措施: Alteration of DBS stimulator settings (Other)
DBS off
DBS off
结局指标
主要结局
Sleep Efficiency
时间窗: 1 month
This is the percentage of time the subject is in bed when he/she is actually asleep.
次要结局
- Wake after sleep onset (WASO)(1 month)
- Two timed motor tasks(1 month)
- Total Sleep Time(1 month)
研究者
Amy Amara, MD
Instructor
University of Alabama at Birmingham