针刺对原发性失眠的影响:随机对照试验

注册号:

Registration number:

AMCTR-IPR-20000328 

注册号获得时间:

Date of releasing the registration number:

2020/2/21 10:56:21 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺对原发性失眠的影响:随机对照试验 

Public title:

Effects of acupuncture on primary insomnia: randomized controlled trials 

研究课题的正式科学名称:

针刺对原发性失眠的影响:随机对照试验 

Scientific title:

Effects of acupuncture on primary insomnia: randomized controlled trials 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

郑蕾 

研究负责人:

邹伟 

Applicant:

Zheng Lei 

Study leader:

Zou Wei 

申请注册联系人电话:

Applicant telephone:

+86 18846186791 

研究负责人电话:

Study leader's telephone:

13351980999 

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:

chinalian@163.com 

研究负责人电子邮件:

Study leader's E-mail:

kuangzou1965@163.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:

黑龙江省哈尔滨市香坊区和平路26号 

研究负责人通讯地址:

黑龙江省哈尔滨市香坊区和平路26号 

Applicant address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China 

Study leader's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, 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:

黑龙江中医药大学附属第一医院 

Applicant's institution:

First Affiliated Hospital,Heilongjiang University of Chinese Medicine 

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:

HZYLLKY202000301 

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:

黑龙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethic Committee of First Affiliated Hospital, Heilongjiang University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-07 

研究实施负责(组长)单位:

黑龙江中医药大学附属第一医院 

Primary sponsor:

First Affiliated Hospital,Heilongjiang University of Chinese Medicine 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市香坊区和平路26号 

Primary sponsor's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, 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):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

黑龙江中医药大学附属第一医院

具体地址:

黑龙江省哈尔滨市香坊区和平路26号

Institution
hospital:

First Affiliated Hospital,Heilongjiang University of Chinese Medicine

Address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

原发性失眠 

Target disease:

primary insomnia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

预实验 

Study phase:

Polit 

研究目的:

通过受试者主观量表与体动记录仪监测的客观指标,评价针刺对原发性失眠的影响。 

Objectives of Study:

Evaluating the effects of acupuncture on primary insomnia by Actigraph and the scales. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1) 性别不限,18岁≤年龄≤60岁; 2) 符合原发性失眠症的诊断标准; 3) 匹兹堡睡眠质量指数(PSQI)评分>7分; 4) SAS评分<50分; 5) SDS评分<53分; 6) 受试者知情同意,并签署相关文件。获得知情同意书过程应符合GCP要求。 

Inclusion criteria

1) Male or female , Aged 18 - 65 years old. 2) Meet the diagnostic criteria for primary insomnia (sleep latency over 30 minutes, and/or the total sleep time<6 hours. Duration of those symptoms was more than 3 times/week and lasted more than 1 month). 3) Pittsburgh Sleep Quality Index (PSQI) score >7 points. 4) Self-rating anxietyscale(SAS) score<50 points. 5) Self-rating depression scale(SDS) score<53 points. 6) Ppatients signed the informed consent. And the process of obtaining informed consent should comply with GCP requirements. 

排除标准:

1) 有以下情况人群:妊娠、哺乳期妇女;合并严重睡眠呼吸暂停、睡眠节律障碍、严重的心脑血管疾病、肝、肾功能异常,急慢性肺部疾病、神经变性疾病(如帕金森病、痴呆等)或癫痫患者;正在使用各种刺激器装置的患者,(如心脏起搏器、脑部深度刺激器、丘脑刺激器、迷走神经刺激器和经颅磁刺激器等); 2) 入组前1月接受药物或物理治疗; 3) 研究者认为具有任何可能导致受试者不能完成本研究或给受试者带来风险的其他任何情况; 4) 法律上的残疾患者(盲、聋、哑、智力障碍),精神病患者; 5) 怀疑或确有酒精、药物滥用病史,或者根据研究者的判断、具有降低入组可能性或使入组复杂化的其他情况,如工作环境经常变动等易造成失访的情况。 

Exclusion criteria:

1) Pregnancy or lactation women;sleep apnea syndrome,circadian disorder;patients with severe primary diseases such as serious disease of heart, brain, kidney, lung or liver;Parkinson’s disease,dementia,epilepsy;patients receiving stimulator therapy such as cardiacpacemaker or vagus nerve stimulator. 2) Patients have received medication or physical therapy during the last month. 3) Any circumtances evaluated by the researcher that could prevent patients completing the research and bring risks to patiens. 4) Legally disabled (blind, deaf, mute, mentally handicapped), psychopath. 5) Patients who are suspected or have a history of alcohol or drug abuse, or those who are likely to lose the interview according to the judgment of the researcher. 

研究实施时间:

Study execute time:

From2020-01-30To 2021-01-30 

干预措施:

Interventions:

组别:

试验组

样本量:

36

Group:

Experimental group

Sample size:

干预措施:

针刺方案1加认知疗法

干预措施代码:

Intervention:

Acupuncture treatment 1 plus Cognitive therapy

Intervention code:

组别:

对照组

样本量:

36

Group:

Control group

Sample size:

干预措施:

针刺方案2加认知疗法

干预措施代码:

Intervention:

Acupuncture treatment 2 plus Cognitive therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital,Heilongjiang University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

主要指标 

Outcome:

PSQI

Type:

Primary indicator 

指标中文名:

焦虑自评量表

指标类型:

主要指标 

Outcome:

SAS

Type:

Primary indicator 

指标中文名:

抑郁自评量表

指标类型:

主要指标 

Outcome:

SDS

Type:

Primary indicator 

指标中文名:

体动记录仪

指标类型:

主要指标 

Outcome:

Actigraphy

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 years

随机方法(请说明由何人用什么方法产生随机序列):

项目负责人将受试者用区组随机分组的方式分成两组

性别:

男女均可

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

Patients will be divided into two groups by the project leader by random grouping

Gender:

Both

盲法:

单盲

Blinding:

single-blind

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验结束后在本平台公开

The way of sharing IPD”(include metadata and protocol, If use web-bassed public database, please provide the url):

After the trail in this platment

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

Microsoft Office Access

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Microsoft Office Access

创建人:

Creater Name:

 2020-01-29
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