Awake & Move. Role of Nocturnal Sleep and Rapid Eye Movement Sleep at Morning Awakening on Sleep Benefit in Parkinson's Disease. An Interventional Cross-over Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Overnight change in objective motor performance
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. The aim of this study is to test the hypothesis that objective and/or subjective improvement of motor function might be due to a carry-over effect of Rapid Eye Movements (REM) sleep at awakening from this sleep phase.
详细描述
The "Awake & Move" study is the second part of the Sleep, Awake & Move project. This study will be conducted in a subgroup of unselected, consecutive patients having completed the part I of the Sleep, Awake & Move project (i.e. the "Sleep & Move" study). The investigators plan to explore the carry-over effect of REM sleep on motor function in a subgroup of PD subjects p. In this interventional study the investigators expect to induce SB by awakening the subjects from nocturnal REM sleep in a sleep laboratory setting, but not from Non-Rapid Eye Movements (NREM) sleep (control intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The sleep technician in charge to apply the study intervention was the only person to be aware of the sleep phase the patient was awaken from.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
排除标准
- •Atypical parkinsonian syndrome
- •Cognitive impairment (MMSE ≥ 26)
- •Deep brain stimulation
- •History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases
- •Psychiatric disorders, excepting mild depression
- •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.
- •subjects with (a) sleep-disordered breathing [Respiratory Disorder Index (RDI)≥ 5] and (b) with no clear-cut distinction of REM and NREM sleep, based on a video-polysomongraphical recording.
研究组 & 干预措施
REM Sleep Awakening (REMSA)
The investigators will actively awaken each subject from nocturnal REM sleep in a sleep laboratory setting, in the hour preceding her/his habitual wake time.
干预措施: REMSA (Behavioral)
NREM Sleep Awakening (NREMSA)
Awakening from the NREM sleep stage N2 will be the control intervention.
干预措施: NREMSA (Behavioral)
结局指标
主要结局
Overnight change in objective motor performance
时间窗: 12 hours
The change of objective measures of morning motor performance at awakening from REM sleep compared to the morning motor performance at awakening from NREM sleep (stage N2), within the same subjects, by mean of an electronic finger tapping test and the Movement Disorders Society Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS-III).
次要结局
- Overnight change in subjective motor performance(12 hours)
研究者
Pietro Luca Ratti
MD, PhD
Neurocenter of Southern Switzerland