NCT01742182已完成不适用
Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Sleep Efficiency
研究概览
简要总结
Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients and healthy controls. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
- •PD Hoehn and Yahr stage 2-4;
- •Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2;
- •Epworth Sleepiness Scale (ESS) score ≥10 in group 1, and <10 in group 2;
- •Control participants will be matched for gender and age with PD participants.
排除标准
- •Atypical or secondary forms of Parkinsonism;
- •Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
- •Presence of depression defined as the Beck Depression Inventory (BDI) score >14;
- •Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed;
- •Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;
- •Use of medications known to affect melatonin secretion;
- •Unstable/serious medical illness.
结局指标
主要结局
Sleep Efficiency
时间窗: June 2012- May 2017
circadian rhythm of melatonin
时间窗: June 2012- May 2017
Daytime Somnolence
时间窗: June 2012- May 2017
次要结局
未报告次要终点
研究者
Aleksandar Videnovic, MD
Assistant Professor of Neurology
Massachusetts General Hospital
研究点 (2)
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