Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Objective prospective and repeated assessment of motor function
研究概览
简要总结
Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory improvement in motor function reported by around 50% of patients affected by Parkinson's Disease (PD) after sleep and before taking their first dose of dopaminergic medications. This study aims at systematically characterizing SB in PD patients in an ecological setting and to explore the relationships between nocturnal and diurnal sleep and subjective and objective measures of motor function. A better understanding of this phenomenon is mandatory for future research on this topic.
详细描述
The "Sleep & Move" study is the first part of the Sleep, Awake & Move project. In this observational study we plan to systematically investigate SB and the day-to-day variation in this phenomenon in PD patients by a prospective, repeated assessment for 14 days of both subjective and objective measures of motor function and sleep at patients' home, by an Android app developed ad hoc by our group and named "SleepFit".
Since is still unknown if a spontaneous, subclinical improvement in motor performance might also occur in healthy subjects or if the SB is a phenomenon only involving subjects with PD, we had the idea to test this hypothesis comparing a subgroup of PD patients with age- and sex-matched healthy volunteers, employing the same assessments as in the Sleep & Move study.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic criteria of idiopathic Parkinson's disease (UKPDBB)
- •Mild to moderate disease (Hoehn & Yahr score ≥ 1 and <= 3)
- •Mentally and physically capable to give informed consent
- •Stable antiparkinsonian and psychotropic therapy for the last 30 days
- •HEALTHY GROUP:
- •Inclusion Criteria:
- •Absence of Parkinson's disease
- •Mentally and physically capable to give informed consent
- •ALL SUBJECTS:
排除标准
- •Atypical parkinsonian syndrome
- •Cognitive impairment (MMSE ≥ 26)
- •History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases
- •Psychiatric disorders, excepting mild depression (BDI score <14)
- •Alcohol abuse
- •Other clinically significant severe concomitant disease states
- •Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.)
- •Participation in another study with investigational drug within the 60 days preceding and during the present project.
结局指标
主要结局
Objective prospective and repeated assessment of motor function
时间窗: from day 0 to day 15
Finger tapping test
次要结局
- Subjective prospective assessment of sleep and wakefulness(from day 0 to day 15)
- Objective prospective and repeated assessment of motor function(from day 0 to day 15)
- Subjective prospective and repeated assessment of motor function(from day 0 to day 15)
- Subjective prospective assessment of sleepiness(from day 0 to day 15)
- Objective prospective assessment of sleep and wakefulness(from day 0 to day 15)
研究者
Pietro Luca Ratti
MD, PhD
Neurocenter of Southern Switzerland