基于体动记录仪探讨‘通督温阳’针刺法干预慢性失眠症的临床疗效研究

注册号:

Registration number:

AMCTR-IPR-19000290 

注册号获得时间:

Date of releasing the registration number:

2019/8/23 20:23:45 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

基于体动记录仪探讨‘通督温阳’针刺法干预慢性失眠症的临床疗效研究 

Public title:

Investigate the Efficacy of 'Tongdu Wenyang' Acupuncture Intervention on Chronic Insomnia Based on Actigraphy 

研究课题的正式科学名称:

基于体动记录仪探讨‘通督温阳’针刺法干预慢性失眠症的临床疗效研究 

Scientific title:

Investigate the Efficacy of 'Tongdu Wenyang' Acupuncture Intervention on Chronic Insomnia Based on Actigraphy 

研究课题代号(代码):

Study subject ID:

2019NL-033-03 

在其它机构的注册号:

Secondary ID:

ChiCTR1900025224 

申请注册联系人:

王晓秋 

研究负责人:

王晓秋 

Applicant:

Wang xiaoqiu 

Study leader:

Wang xiaoqiu 

申请注册联系人电话:

Applicant telephone:

+86 17805008180 

研究负责人电话:

Study leader's telephone:

+86 17805008180 

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:

1003937028@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1003937028@qq.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:

江苏省南京市秦淮区汉中路155号 

研究负责人通讯地址:

江苏省南京市秦淮区汉中路155号 

Applicant address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, China 

Study leader's address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

210029 

研究负责人邮政编码:

Study leader's postcode:

210029 

申请人所在单位:

江苏省中医院 

Applicant's institution:

Jiangsu Provincial Hospital 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:

2019NL-033-03 

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:

南京中医药大学附属医院(江苏省中医院)伦理委员会 

Name of the ethic committee:

IRB of Affiliate Hospital of Nanjing University Chinese Medicine (Jiangsu Province Hospital of Traditional Chinese Medicine) 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-14 

研究实施负责(组长)单位:

江苏省中医院 

Primary sponsor:

Jiangsu Provincial Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

江苏省南京市秦淮区汉中路155号 

Primary sponsor's address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

江苏省中医院

具体地址:

江苏省南京市秦淮区汉中路155号

Institution
hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, China

经费或物资来源:

江苏省中医院 

Source(s) of funding:

Jiangsu Provincial Hospital of Traditional Chinese Medicine 

研究疾病:

慢性失眠症 

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:

预实验 

Study phase:

Polit 

研究目的:

主要目的:运用体动记录仪结合量表客观评价针刺治疗慢性失眠症的临床疗效; 次要目的:运用体动记录仪监测指标分析慢性失眠症患者的睡眠节律 

Objectives of Study:

The main purpose: Objectively evaluate the clinical efficacy of acupuncture in the treatment of chronic insomnia by Actigraphy combined with the scale; Secondary purpose: Describe the sleep rhythm of patients with chronic insomnia based on Actigraphy. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.年龄为18-65岁,符合慢性失眠症诊断标准; 2.PSQI评分>5分; 3.签署知情同意书。 

Inclusion criteria

1. Aged 18-65 years old, meet ICSD-3 diagnostic criteria; 2. PSQI score > 5 points; 3. Signed informed consent. 

排除标准:

①癫痫,糖尿病,心血管疾病,肾衰竭,高血压,代谢性疾病或良性前列腺增生症等器质性疾病引起的睡眠障碍; ②抑郁症,焦虑症,精神分裂症或其他严重精神疾病引起的睡眠障碍;接受过精神类药物治疗; ③其他睡眠障碍的诊断,或在基线时发现任何其他睡眠障碍,如阻塞性睡眠呼吸暂停,快速眼动(REM)睡眠障碍; ④帕金森病、不宁腿综合征等其他体动异常类疾病; ⑤过去一个月曾接受过针灸治疗失眠; ⑥酒精和/或其他药物滥用或依赖; ⑦排除不能配合填写量表,文化程度较低者,沟通和认知障碍。 

Exclusion criteria:

1. Sleep disorders caused by organic diseases such as epilepsy, diabetes, cardiovascular diseases, renal failure, hypertension, metabolic diseases or benign prostatic hyperplasia; 2. Sleep disorders caused by depression, anxiety, schizophrenia or other serious mental illness; 3. Diagnosis of other sleep disorders, or any other sleep disorders found on the PSG at baseline, such as obstructive sleep apnea, rapid eye movement (REM) sleep disorder; 4. Parkinson's disease, restless legs syndrome and other abnormal physical and motor diseases 5. Acupuncture has been treated for insomnia in the past month; 6. Exclude participants who are unable to complete the scale or those with lower education; 7. Alcohol and/or other drugs abuse or dependence. 8. received psychotropic medication; 9. With communication and cognitive impairment. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

假针刺

干预措施代码:

Intervention:

shame acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

江苏省中医院 

单位级别:

三级甲等 

Institution
hospital:

Jiangsu Provincial Hospital of Traditional 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:

Pittsburgh Sleep Quality Index

Type:

Primary indicator 

指标中文名:

睡眠严重指数量表

指标类型:

主要指标 

Outcome:

Insomnia Severity Index

Type:

Primary indicator 

指标中文名:

疲劳严重程度量表

指标类型:

主要指标 

Outcome:

Fatigue Severity Scale

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:

标本中文名:

组织:

Sample Name:

none

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

Pending

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):

信封装入应急预案(未描述随机方法)

性别:

男女均可

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

Envelope loading emergency plans

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:

 2019-08-23
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