French Validation of a Severity Scale in REM Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- French validation of a new scale of severity of REM Sleep behavior disorder for patient
研究概览
简要总结
REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. RBD is often associated to neurodegenerative diseases, and may even precede them for several years as an early marker. Currently, there is no scale or tool for assessing the severity of RBD. Nevertheless, it is crucial to have a tool of severity when one wants to study the natural evolution of this disorder, as well as the possible effect of a drug in the context of a clinical trial. A Severity Scale of RBD has recently been proposed within the International RBD Study Group and an international validation study in several languages is being considered.
The main objective of this study is to validate a new scale of severity of the REM sleep behavior disorder (RBD Severity Scale or RBDSS) and to characterize its metrological properties, in particular its concurrent validity, internal consistency and reproducibility
详细描述
Research involving the human person, non-interventional, category 3
80 patients with RBD of any etiology (eg Idiopathic RBD, RBD associated with Parkinson's Disease, Multiple System Atrophy, Narcolepsy etc.) and their bedpartners (if available) will be include in 5 French centers (Clermont-Ferrand, Paris, Nantes, Montpellier et Lyon) Patients, and their bedpartners (if available), will be seen 2 times at 1 week intervals.
For the patients Visit 1 (Day 0): duration : 60 minutes
- Information to patient and collection of non-opposition
- Collection of socio-demographic data: age, sex, level of education
- Clinical data collection: duration of RBD, duration and severity of the concomitant disease:, medical and surgical history
- Assessment of cognitive functions: Mini Mental State Examination
- Verification of inclusion / exclusion criteria
- Ongoing treatments and calculation of Levodopa Equivalent Daily Dose (LEDD) for PD patients.
- RBD severity scale for Patient (RBDSS-PT) + Global Clinical Impression-Severity Scale
Visit 2 (J7) : duration : 20 minutes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •RBD patients:
- •Men or women aged 30 to 80
- •Patients with idiopathic and secondary RBD (including RBD associated with Parkinson's disease, Narcolepsy, Multiple System Atrophy or other neurological diseases) diagnosed according to the latest international criteria Classification of Sleep Disorders (ICSD-3 ).
- •Cooperation and understanding to strictly comply with the conditions laid down in the protocol
- •Affiliated to a social security system
- •bedpartners
- •Men or women aged 30 to 80
- •Subjects sharing the same bed as the patient for ≥70% of the time (e.g. at least 5 nights / week, or 20 nights / month)
- •-Cooperation and understanding to strictly comply with the conditions described in the protocol
- •Affiliated to a social security system
排除标准
- •- RBD patients:
- •Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive Disorder)
- •Untreated Obstructive Sleep Apnea Syndrome (OSAS) (with IAH> 15 / h at vPSG)
- •Patients under tutorship or curatorship or safeguard of justice
- •No change in treatment should have occurred during the 4 weeks prior to inclusion in the study and no change in treatment should be expected a priori within one week of inclusion
- •Bedpartners
- •Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive Disorder)
- •Patients under tutorship or curatorship or safeguard of justice
结局指标
主要结局
French validation of a new scale of severity of REM Sleep behavior disorder for patient
时间窗: Day 0
The scale contains 8 items in the patient version. Each of them focusing on one RBD symptom, are evaluated in terms of their frequency and severity. This scale was administered at Day 0 to evaluate concurrent validity, internal consistency and reproducibility
次要结局
- Evaluation of the fluctuations in the frequency and severity of RBD symptoms and their "night-to-night" variability through the collection of daily data over a four-week period(Day 28)
- French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners(Day 0)
- Evaluation of the RBD severity using Clinical Global Impression-Severity(Day 7)
- Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD(Day 7)