中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR-RPC-15007219
最近更新日期： Date of Last Refreshed on：	2015-10-15 16:05:38
注册时间： Date of Registration：	2015-09-22 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	快速动眼期睡眠行为障碍及其相关神经变性疾病的发病机制研究
Public title：	Research of the pathogenesis of REM sleep behavior disorder andits relationship with other neural degeneration diseases
注册题目简写：
English Acronym：
研究课题的正式科学名称：	快速动眼期睡眠行为障碍及其相关神经变性疾病的发病机制研究
Scientific title：	Research of the pathogenesis of REM sleep behavior disorder andits relationship with other neural degeneration diseases
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	王雁	研究负责人：	王雁
Applicant：	Wang Yan	Study leader：	Wang Yan
申请注册联系人电话： Applicant telephone：	+86 15721570936	研究负责人电话： Study leader's telephone：	+86 15721570936
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	wang_yan_2013@126.com	研究负责人电子邮件： Study leader's E-mail：	wang_yan_2013@126.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	上海市黄浦区凤阳路415号	研究负责人通讯地址：	上海市黄浦区凤阳路415号
Applicant address：	415 Fengyang Road, Shanghai, China	Study leader's address：	415 Fengyang Road, Shanghai, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	第二军医大学附属长征医院神经内科
Applicant's institution：	Department of Neurology, Changzheng Hospital, Second Military Medical University
研究负责人所在单位：
Affiliation of the Leader：

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	20150302	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	第二军医大学生物医学研究伦理委员会
Name of the ethic committee：	Second Military Medical University Biomedical Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	1990-01-01 00:00:00
伦理委员会联系人：
Contact Name of the ethic committee：
伦理委员会联系地址：
Contact Address of the ethic committee：
伦理委员会联系人电话： Contact phone of the ethic committee：		伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

第二军医大学附属长征医院神经内科

Primary sponsor：

Department of Neurology, Changzheng Hospital, Second Military Medical University

研究实施负责（组长）单位地址：

上海市黄浦区凤阳路415号

Primary sponsor's address：

415 Fengyang Road, Shanghai, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	第二军医大学附属长征医院神经内科	具体地址：	上海市黄浦区凤阳路415号
Institution hospital：	Department of Neurology, Changzheng Hospital, Second Military Medical University	Address：	415 Fengyang Road, Shanghai, China

经费或物资来源：

国家自然科学基金（81070070；81171252）

Source(s) of funding：

national natural science foundation project（81070070；81171252）

研究疾病：

快速动眼期睡眠行为障碍；神经变性疾病

Target disease：

REM sleep behavior disorder; neurodegeneration disease

研究疾病代码：

Target disease code：

研究类型：

病因学/相关因素研究

Study type：

Cause/Relative factors study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

观察快速动眼期睡眠行为障碍的特点，在神经变性疾病中的发生情况；代谢组学比较伴或不伴神经变性疾病的快速动眼期睡眠行为障碍患者血液、唾液、脑脊液样本，探讨快速动眼期睡眠行为障碍的发病机制。

Objectives of Study：

Observe the characteristics andoccurrence of REM sleep behavior disorder in neurodegenerative disease ; Metabolomics analysis of blood, saliva, cerebrospinal fluid samples of rem sleep behavior disorder patients with or without neurodegenerative diseases; explore the pathogenesis of rem sleep behavior disorder.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

2.1. Control group: in terms of gender, age, level of education are matching with cases kindergarden crowd's medical center. (1) in line with the diagnostic criteria for healthy people; (2) the history, eliminate the following situation: sleep is harmful or potentially dangerous sleep behavior, behavior associated with the dream, from the abnormal behavior of destroying the continuity of sleep. (3) voluntarily signed informed consent.
2.2. IRBD groups: since December 1, 2012 to October 31, 2014 in our hospital neurology clinics and sleep disorder of iRBD patients ZhuanBing, satisfy the following set of standards: (1) PSG confirmed iRBD patients; (2) there is no definite neurological lesions, no obvious cognitive impairment, not accompany with other sleep disorders; (3) no nervous system abnormalities; Neuroimaging examination was normal; (4) primary school education level above (6 years or higher) education years, MMSE score 24 points or more; (5) + MSLT PSG monitoring out of sleep apnea hypoventilation syndrome/sleep,(3) voluntarily signed informed consent.
2.3. PD group: since December 1, 2012 to October 31, 2014 in our hospital neurology clinic of PD patients, satisfy the following set of standards: (1) PD diagnosis standard; (2) by history and PSG examination, eliminate RBD merger; (3) age more than 30 years of age, gender not limited; (4) primary school education level above (6 years or higher) education years, MMSE score 24 points or more; (5) voluntarily signed informed consent. 
2.4. SRBD + RBD (PD) group: since December 1, 2012 to October 31, 2014 patients in the department of neurology clinic, satisfy the following set of standards: (1) PD diagnosis standard; (2) by clinical assessment and PSG examination, conforms to the RBD diagnostic criteria; (3) age more than 30 years of age, gender not limited; (3) primary school education level above (6 years or higher) education years, MMSE score 24 points or more; (4) voluntarily signed informed consent.

排除标准：

2.1.对照组：(1）不符合健康人诊断标准者，或既往有神经系统疾病或精神病病史；（2）有严重不良生活方式者；（3）近期内(4周内)有各种感染者；（4）妊娠或哺乳期妇女；（5）未签署知情同意书者；（6）研究人员认为有其他原因不适合者。
2.2.iRBD组：（1）有神经系统病变者，既往有脑炎、脑外伤、癫痫、变性疾病等神经精神疾病病史，神经影像学检查有异常者；（2）目前正在有规律服用安眠药或抗精神病药物的患者，仍在使用镇静催眠类药物或酒精助眠1周内不能撤退者；（3）存在未解决的重大生活事件和心理冲突；（4）PSG检查不能合作者或PSG中，整晚睡眠无REM期者；（5）不能完成量表评估者；（6）未自愿签署知情同意书。
2.3. PD组：（1）反复卒中病史，伴随阶梯进展的PD症状；反复脑外伤病史；明确的脑炎病史，有动眼危象；（2）脑血管病、脑炎、外伤、药物所致的帕金森综合征及帕金森叠加综合征；（3）恶性肿瘤、癫痫、药物或酒精依赖者；（4）严重心、肺疾病影响睡眠者，从事倒班工作者；（5）MMSE评分<24分者(文盲和小学文化者低于20分)；（6）伴有重度睡眠呼吸暂停/低通气综合症、发作性睡病等其他睡眠疾病。（7）未自愿签署知情同意书。
2.4. sRBD（PD+RBD）组：（1）帕金森综合征、帕金森叠加综合征患者或其他神经系统变性疾病患者；（2）因严重进行性神经系统病变或病情进展致使临床检查不能独自配合完成者；（3）目前正在有规律服用安眠药或抗精神病药物的患者，仍在使用镇静催眠类药物或酒精助眠1周内不能撤退者；（4）PSG检查不能合作者，或PSG中，整夜睡眠无REM期者；（5）伴有重度睡眠呼吸暂停/低通气综合症、发作性睡病等其他睡眠疾病。（6）未签署知情同意书者。

Exclusion criteria：

2.1. The control group: (1) does not conform to the diagnostic criteria of healthy people or a history of nervous system disease or mental illness; (2) have serious adverse lifestyle; (3) in the near term (4 weeks) have all kinds of infections; (4) pregnancy or lactation women; (5) not signed informed consent enters; (6) the researchers think that there are other reasons are not suitable for.
2.2. IRBD groups: (1) with the nervous system lesions, has a encephalitis, brain injury, epilepsy, degenerative diseases such as neural history of mental illness, neural imaging examination was abnormal; (2) is now in regular use sleeping pills or patients with antipsychotic drugs, still use sedative hypnotic drugs or alcohol sleeping 1 weeks can't retreat; (3) there is not solved major life events and psychological conflict; (4) PSG examination can't collaborators or PSG, without REM sleep all night; (5) scale evaluator can not be completed, (6) not voluntarily signed informed consent.
2.3. The PD group: (1) the history of stroke, repeatedly with ladder progress of PD symptoms; History of repeated traumatic brain injuries; Clear history of encephalitis, oculomotor crisis; (2), encephalitis, cerebrovascular disease, trauma, drug caused by superposition of Parkinson's syndrome and Parkinson's syndrome; (3) malignant tumors, epilepsy, drug or alcohol dependence. (4) serious heart and lung diseases affect sleep, engaged in shift workers; (5) the MMSE score < 24 points (illiteracy and primary Wen Huazhe below 20 points); (6) associated with severe sleep apnea hypoventilation syndrome/sleep, sleep onset disease and other diseases. (7) not voluntarily signed informed consent.
2.4. SRBD + RBD (PD) group: (1) the superposition of Parkinson's syndrome, Parkinson's disease or other nervous system degenerative disease syndrome patients; (2) for severe progressive neurological disease or condition that clinical examination alone cannot cooperate municipality; (3) are regularly take sleeping pills or patients with antipsychotic drugs, still use sedative hypnotic drugs or alcohol sleeping 1 weeks can't retreat; (4) PSG examination can't collaborators, or PSG, without REM sleep all night; (5) associated with severe sleep apnea hypoventilation syndrome/sleep, sleep onset disease and other diseases. (6) not signed informed consent will be.

研究实施时间：

Study execute time：

从 From 2016-01-01 00:00:00至 To 2018-01-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2016-01-01 00:00:00 至 To 2017-10-01 00:00:00

干预措施：

Interventions：

组别：	Case series	样本量：	120
Group：	Case series	Sample size：	120
干预措施：	Nil	干预措施代码：
Intervention：	Nil	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	第二军医大学附属长征医院	单位级别：	三级甲等
Institution hospital：	Changzheng Hospital, Second Military Medical University	Level of the institution：	Tertiary A hospital

测量指标：

Outcomes：

指标中文名：	代谢组学	指标类型：	主要指标
Outcome：	metabolomics	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	多导睡眠检测	指标类型：	主要指标
Outcome：	Polysomnography	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	脑脊液	组织：
Sample Name：	cerebrospinal fluid	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	尿液	组织：
Sample Name：	urine	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age		岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

第二军医大学统计教研室教员采用计算机软件产生随机序列

Randomization Procedure (please state who generates the random number sequence and by what method)：

computer software method is used to generate random sequence by researchers of statistics teaching and research section in the second military medical university

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：
数据与安全监察委员会： Data and Safety Monitoring Committee：
注册人： Name of Registration：	2015-10-15 16:05:38