针刺治疗慢性失眠的多中心、随机对照试验

注册号:

Registration number:

AMCTR-IOR-18000167 

注册号获得时间:

Date of releasing the registration number:

2019/9/28 22:28:33 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺治疗慢性失眠的多中心、随机对照试验 

Public title:

Acupuncture for chronic insomnia: A single blind, randomized controlled trial 

研究课题的正式科学名称:

针刺治疗慢性失眠的多中心、随机对照试验 

Scientific title:

Acupuncture for chronic insomnia: A single blind, randomized controlled trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800016068 

申请注册联系人:

付聪 

研究负责人:

陈云飞 

Applicant:

Cong FU 

Study leader:

Yunfei Chen 

申请注册联系人电话:

Applicant telephone:

+86 13661949662 

研究负责人电话:

Study leader's telephone:

+86 18930568221 

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:

applepie_cong@126.com 

研究负责人电子邮件:

Study leader's E-mail:

icyf1968@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:

上海市虹口区甘河路110号岳阳医院 

研究负责人通讯地址:

上海市虹口区甘河路110号岳阳医院 

Applicant address:

110 Ganhe Road, Hongkou District, Shanghai, China 

Study leader's address:

110 Ganhe Road, Hongkou District, 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:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Hospital of Intergrated Traditional Chinese and Western Medicine, Shanghai University of Traditional 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:

2018-033 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

上海中医药大学附属岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

IRB of Yueyang Hospital of Intergrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-01 

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor:

Yueyang Hospital of Intergrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号岳阳医院 

Primary sponsor's address:

110 Ganhe Road, Hongkou District, 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):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号岳阳医院

Institution
hospital:

Yueyang Hospital of Intergrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District, Shanghai, China

经费或物资来源:

上海市科学技术委员会 

Source(s) of funding:

Science and Technology Commmission Shanghai Municipalit 

研究疾病:

慢性失眠 

Target disease:

Chronic 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:

其它 

Study phase:

Other 

研究目的:

评价短期针刺“申脉”、“照海”穴对慢性失眠患者的临床疗效。 

Objectives of Study:

To evaluate the short-term efficacy of acupuncture on chronic insomniacs. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)年龄处于18-65岁; (2)符合ICSD-3中慢性失眠的诊断标准; (3)睡眠严重程度量表(Insomnia Severity Index, ISI)评分≥11分; (4)签署知情同意书。 

Inclusion criteria

1. aged 18-65 years old; 2. the diagnosis of chronic insomnia is made according to International Classification of Sleep Disorders, Third Edition; 3. a total score ≥11 on Insomnia Severity Index questionnaire; 4. given informed consent. 

排除标准:

(1)曾因失眠接受针刺治疗; (2)近一个月服用的镇静催眠药物及精神类药物不稳定者; (3)多导睡眠图(Polysomnography, PSG)监测示睡眠呼吸暂停低通气指数≥15或周期性肢体运动伴微觉醒≥15; (4)曾经或本次临床访谈中诊断为精神疾病; (5)汉密尔顿抑郁量表17项版本评分≥17分; (6)因躯体疾病存在失眠症状,如夜间不适、疼痛或呼吸困难等,或因服用精神活性物质或药物存在失眠症状; (7)有严重心、肝、肾功能损伤,或血液、呼吸系统疾病,或肝病、艾滋病等传染性疾病和严重外伤未痊愈者; (8)针刺穴位局部有皮肤或组织感染; (9)近3月内曾参与其他课题。 

Exclusion criteria:

1. have experience on acupuncture for treating insomnia; 2. sedative hypnotic drugs and psychotropic drugs are taken unstably in the past month; 3. have a PSG-detected apnea-hypopnea index of 15 or greater or a periodic limb movement index with arousal of 15 or greater; 4. were diagnosed with psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V); 5. a total score ≥17 on 17-item Hamilton Depression Rating Scale; 6. have insomnia symptoms due to other medical conditions such as pain or dyspnea or due to drug or substance; 7. have any serious physical illness; 8. have an infection close to the position of the specified acupoints; 9. have participated in any clinical trial in the last 3 month. 

研究实施时间:

Study execute time:

From2018-03-15To 2019-12-31 

干预措施:

Interventions:

组别:

假针刺组

样本量:

30

Group:

sham acupuncture group

Sample size:

干预措施:

浅刺双侧假申脉、照海穴

干预措施代码:

Intervention:

acupuncture at bilateral sham KI 6 and bilateral sham BL 62

Intervention code:

组别:

申脉-照海组

样本量:

30

Group:

Acupuncture KI 6- BL 62

Sample size:

干预措施:

针刺双侧申脉、照海穴

干预措施代码:

Intervention:

Acupuncture at bilateral KI 6 and bilateral BL 62

Intervention code:

组别:

筑宾-申脉组

样本量:

30

Group:

Acupuncture KI 9- BL 62

Sample size:

干预措施:

针刺双侧申脉、筑宾穴

干预措施代码:

Intervention:

Acupuncture at bilateral KI 9 and bilateral BL 62

Intervention code:

组别:

金门-照海组

样本量:

30

Group:

Acupuncture KI 6- BL 63

Sample size:

干预措施:

针刺双侧金门、照海穴

干预措施代码:

Intervention:

Acupuncture at bilateral KI 6 and bilateral BL 63

Intervention code:

组别:

筑宾-金门组

样本量:

30

Group:

Acupuncture KI 9- BL 63

Sample size:

干预措施:

针刺双侧金门、筑宾穴

干预措施代码:

Intervention:

Acupuncture at bilateral KI 9 and bilateral BL 63

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):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三级甲等教学和综合性医院 

Institution
hospital:

Yueyang Hospital of Intergrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市嘉定区中医医院 

单位级别:

二级甲等教学医院 

Institution
hospital:

JiaDing Hospital of Traditional Chinese Medicine  

Level of the institution:

Second A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市浦东新区人民医院 

单位级别:

二级甲等教学和综合性医院 

Institution
hospital:

PuDong New Area People's Hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

睡眠严重程度量表

指标类型:

主要指标 

Outcome:

Insomnia Severity Index, ISI

Type:

Primary indicator 

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

次要指标 

Outcome:

Pittsburgh Sleep Quality Index, PSQI

Type:

Secondary indicator 

指标中文名:

睡眠日志

指标类型:

次要指标 

Outcome:

sleep log

Type:

Secondary indicator 

指标中文名:

Beck抑郁自评量表

指标类型:

次要指标 

Outcome:

Beck Depression inventory, BDI

Type:

Secondary indicator 

指标中文名:

Beck焦虑自评量表

指标类型:

次要指标 

Outcome:

Beck Anxiety Inventory, BAI

Type:

Secondary indicator 

指标中文名:

疲劳量表-14

指标类型:

次要指标 

Outcome:

Fatigue Scale-14, FS-14

Type:

Secondary indicator 

指标中文名:

状态-特质焦虑问卷

指标类型:

次要指标 

Outcome:

State-Trait Anxiety Inventory, STAI

Type:

Secondary indicator 

指标中文名:

睡眠个人信念和态度量表简化版

指标类型:

次要指标 

Outcome:

Dysfunctional Beliefs and Attitudes about Sleep, DBAS-16

Type:

Secondary indicator 

指标中文名:

斯坦福嗜睡量表

指标类型:

次要指标 

Outcome:

Stanford Sleepiness Scale, SSS

Type:

Secondary indicator 

指标中文名:

多导睡眠图

指标类型:

次要指标 

Outcome:

Polysomnography

Type:

Secondary indicator 

指标中文名:

腕动仪

指标类型:

次要指标 

Outcome:

Actigraphy

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

根据SPSS 23.0软件产生完全随机数字表。

性别:

男女均可

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

The group allocation list was generated by using SPSS 23.0.

Gender:

Both

盲法:

Blinding:

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:

即时公开/Real time access

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):

2020年1月前公开原始数据,上传至此平台。

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

We will share our documents before June, 2020. All the data can be looked up on this website.

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):

采用病例记录表采集数据,EpiData 3.1作为电子管理数据。

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

We will use Case Record Form as data collection and EpiData 3.1 as electronic data caputure.

创建人:

Creater Name:

 2018-05-11
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