Evolution of REM Sleep Behavior Disorder in Parkinson's Disease Patients RBD Diagnosed Three Years Earlier
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- presence of REM sleep Behavior Disorder confirmed during the video polysomnography
研究概览
简要总结
About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a parasomnia characterized by partial or complete loss of REM sleep muscle atonia and dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis.
RBD in PD is believed to be a marker of a more widespread degenerative process and a marker of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired in both motor and non-motor domains, compared to those without RBD, with an increased risk of dementia. However, little is know about the relationship between the evolution of RBD, clinic and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal vPSG study has been performed in PD-RBD population.
Thus, the main objective of this study is to longitudinally evaluate clinical and video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.
详细描述
Type of study: longitudinal study, interventional, cross-sectional;
Number of centres: 1 (Clermont-Ferrand)
Patients: patients with Parkinson's Disease associated with REM sleep behavior disorder (PD-RBD) having already underwent video-polysomnography recording, clinical and neuropsychological evaluation in clinical setting or in the study "RBHP 2013 DURIF " at least three years ago.
Study performance:
This study will be developed in two phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
open
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically confirmed idiopathic Parkinson's Disease, according to the United Kingdom Parkinson Disease Bran Bank criteria, associated with RBD, diagnosed according to the International Classification of Sleep Disorders third edition, that have been already enrolled in the study "RBHP 2013 DURIF", or that have already underwent vPSG recording,clinical and neuropsychiatric evaluation in clinical setting;
- •Male and female aged between 45 to 85 years old;
- •All patients are volunteers and have given written informed consent;
- •All patients are able to understand and to perform all tests included in this protocol;
- •User-friendly in French language, both oral and written
排除标准
- •Patients with neurological diseases other than PD;
- •Patients with psychiatric comorbidities (hallucinations, psychosis) according to the DSM-
- •Patients with Obstructive Sleep Apnea Syndrome (Apnea/hypopnea index >15/h);
- •Patients in guardianship or tutorship;
- •Patients enrolled exclusively in another study.
结局指标
主要结局
presence of REM sleep Behavior Disorder confirmed during the video polysomnography
时间窗: at day 0
次要结局
- The Luria motor sequences(at day 1)
- The REM sleep Behavior Disorder severity measured by the REM sleep Behavior Disorder scale(at day 0)
- The impulsivity measured by the Test of Kirby score(at day 0)
- The Hoehn and Yahr scale score(at day 0)
- The Unified Parkinson disease Rating scale score(at day 0)
- The behavioral disorders measured by the Ardouin Scale of Behavior in Parkinson's Disease score(at day 0)
- - The Orthostatic hypotension measured by the Scale for outcomes in PD- autonomic questionnaire(at day 0)
- The Empan test score(at day 1)
- The Visual Object and Space Perception Battery test score(at day 1)
- The impulsivity measured by the Stop signal reaction time score(at day 0)
- The Epworth sleepiness scale score(at day 0)
- The Urgency premeditation perseverance and sensation seeking test(at day 0)
- The Non-motor symptoms Questionnaire score(at day 0)
- The dream content(at day 0)
- The Mini mental state examination score(at day 1)
- The Modified Wisconsin Card Sorting Test(at day 1)
- The Iowa Gambling test score(at day 1)
- The Rey-Osterrieth complex figure(at day 1)
- The Aggressive questionnaire score(at day 0)
- The Hospital Anxiety and Depression Rating Scale(at day 0)
- The California Verbal Learning Test score(at day 1)
- The fluency verbal test score(at day 1)
- The Stroop score(at day 1)
- The Lille Apathy Rating Scale score(at day 1)