Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Daytime Sleepiness
研究概览
简要总结
Rapid eye movement (REM) sleep behavior disorder (RBD) is a sleep disorder in which you act out dreams during REM sleep. Sleep disturbances are very common in RBD, where they negatively impact patients' quality of life and safety. One of the known causes of sleep disturbance is the impairment of the "circadian rhythm", or the human sleep/wake cycle. The purpose of this study is to examine the role of disruption of the circadian rhythm in the development of RBD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years
- •40 yrs of age
排除标准
- •Other significant neurological disorder
- •Untreated significant sleep apnea and/or current sleep apnea symptoms as assessed by the clinical investigator
- •Co-existent restless legs syndrome (RLS), as assessed by the ICDS diagnostic criteria for RLS
- •Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) score of ≤ 23
- •Presence of depression defined as the Beck Depression Inventory (BDI) score >20
- •Use of tricyclic antidepressants, MAO inhibitors or selective serotonin reuptake inhibitors since they may induce/worsen RBD, unless on a stable dose of medication for at least 8 weeks
- •Use of medications known to affect melatonin secretion, such as lithium, α- and β-adrenergic antagonists
- •Shift work, currently or within the prior 3 months
- •Travel through ≥ 2 time zones within 60 days prior to the screening
结局指标
主要结局
Objective Daytime Sleepiness
时间窗: Study Day 17
MSLT (Multiple Sleep Latency Test) assessed via Polysomnography
REM Sleep Phenomena
时间窗: Study Day 16-17
REM (rapid eye movement) sleep duration, REM Index, and EMG (electromyographic) activity) assessed via overnight Polysomnography
Circadian Amplitude
时间窗: Study Day 17-18
amplitude and area under the curve (AUC) of serum melatonin and clock gene expression
次要结局
未报告次要终点
研究者
Aleksandar Videnovic, MD
Principal Investigator
Massachusetts General Hospital