延年九转法治疗慢性失眠的临床疗效及EEG/fMRI特征影响研究

注册号:

Registration number:

ITMCTR2024000534

最近更新日期:

Date of Last Refreshed on:

2024-10-12

注册时间:

Date of Registration:

2024-10-12

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

延年九转法治疗慢性失眠的临床疗效及EEG/fMRI特征影响研究

Public title:

Study on the clinical effect and the influence of EEG/fMRI characteristics of Prolong Life With Nine Turn Method on chronic insomnia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

延年九转法治疗慢性失眠的临床疗效及EEG/fMRI特征影响研究

Scientific title:

Study on the clinical effect and the influence of EEG/fMRI characteristics of Prolong Life With Nine Turn Method on chronic insomnia

研究课题的正式科学名称简写:

Scientific title acronym:

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:

崔家禾

研究负责人:

姚斐

Applicant:

Cui-Jiahe

Study leader:

YaoFei

申请注册联系人电话:

Applicant telephone:

18624900697

研究负责人电话:

Study leader's telephone:

13585975106

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:

jiahehe158@163.com

研究负责人电子邮件:

Study leader's E-mail:

doctoryaofei@126.com

申请单位网址(自愿提供):

Study leader's 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:

上海市静安区芷江中路274号

研究负责人通讯地址:

上海市静安区芷江中路274号

Applicant address:

274 Zhijiang Middle Road, Jing 'an District, Shanghai

Study leader's address:

Zhijiang Middle Road, No. 274, Shanghai

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市中医医院

Applicant's institution:

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024SHL-KY-92-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

上海市中医医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/26 0:00:00

伦理委员会联系人:

凌丽

Contact Name of the ethic committee:

ling Li

伦理委员会联系地址:

上海市芷江中路274号

Contact Address of the ethic committee:

Zhijiang Middle Road, No. 274, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

021-56628310

伦理委员会联系人邮箱:

Contact email of the ethic committee:

shszyyyec@126.com

研究实施负责(组长)单位:

上海中医药大学附属市中医医院

Primary sponsor:

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市芷江中路274号

Primary sponsor's address:

Zhijiang Middle Road No. 274 Shanghai

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):

静安区

Country:

China

Province:

Shanghai

City:

Jingan

单位(医院):

上海中医药大学附属市中医医院

具体地址:

上海市芷江中路274号

Institution
hospital:

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

Address:

Zhijiang Middle Road No. 274 Shanghai

经费或物资来源:

国家自然科学基金(82374610)

Source(s) of funding:

National Natural Science Foundation of China(82374610)

研究疾病:

慢性失眠

研究疾病代码:

Target disease:

Chronic insomnia

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

本研究采用临床量表、血液酶联免疫检测法、PSG和fMRI探讨延年九转法治疗慢性失眠的临床疗效及作用机制,为慢性失眠的防治提供新思路。

Objectives of Study:

In this study, clinical scale, blood ELISA, PSG and fMRI were used to explore the clinical efficacy and mechanism of the treatment of chronic insomnia with Prolong Life With Nine Turn Method, providing new ideas for the prevention and treatment of chronic insomnia.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)符合ISCD-3关于慢性失眠的诊断标准;(2)失眠严重程度指数量表(ISI)总分≥8分;(3)年龄范围20岁~60岁,男女不限,右利手;(4)能够理解量表内容,配合治疗并完成相应评定,无沟通障碍者;(5)自愿加入本研究并签署知情同意书。

Inclusion criteria

(1) Meet the diagnostic criteria of ISCD-3 for chronic insomnia; (2) The total score of the insomnia Severity Index Scale (ISI) is ≥8 points; (3) Age range 20 ~60 years old male and female right-handed; (4) Those who can understand the content of the scale cooperate with treatment and complete the corresponding assessment and have no communication disorders; (5) Voluntarily join the study and sign the informed consent.

排除标准:

(1)近两周内服用能够影响认知功能的药物;(2)合并其他任何精神类疾病者;(3)任何其他疾病或服用药物引起失眠者;(4)合并肝、肾、心脑血管或其他系统严重急慢性疾病者;(5)妊娠及哺乳期妇女;(6)正在参加其他临床试验未结束者。

Exclusion criteria:

(1) Taking drugs that affect cognitive function within the last two weeks; (2) with any other mental illness; (3) insomnia caused by any other illness or medication; (4) Patients with severe acute and chronic diseases of liver kidney cardiovascular and cerebrovascular systems or other systems; (5) Pregnant and lactating women; (6) Those who are participating in other clinical trials that have not been completed.

研究实施时间:

Study execute time:

From 2024-11-01

To      2027-12-31

征募观察对象时间:

Recruiting time:

From 2024-11-01

To      2027-12-31

干预措施:

Interventions:

组别:

CBT组

样本量:

174

Group:

CBT

Sample size:

干预措施:

行为认知教育

干预措施代码:

Intervention:

Cognitive behavior treatment

Intervention code:

组别:

PLWNT组

样本量:

174

Group:

PLWNT

Sample size:

干预措施:

延年九转法气功干预

干预措施代码:

Intervention:

Qigong intervention

Intervention code:

样本总量 Total sample size : 348

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市中医医院

单位级别:

三级甲等

Institution/hospital:

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

Level of the institution:

tertiary first class

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曙光医院

单位级别:

三级甲等

Institution/hospital:

Shuguang Hospital Shanghai University of Traditional Chinese Medicine

Level of the institution:

tertiary first class

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

Institution/hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

Level of the institution:

tertiary first class

测量指标:

Outcomes:

指标中文名:

SF-36 健康调查问卷

指标类型:

次要指标

Outcome:

Medical Outcomes Survey Short Form-36

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

主要指标

Outcome:

Pittsburgh Sleep Quality Index

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多维疲劳问卷

指标类型:

次要指标

Outcome:

Multidimensional Fatigue Inventory

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃肠道症状评定量表

指标类型:

次要指标

Outcome:

Gastrointestinal Symptom Rating Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多导睡眠图

指标类型:

次要指标

Outcome:

Polysomnograph

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静息态功能磁共振

指标类型:

次要指标

Outcome:

Resting state functional magnetic resonance

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

过度觉醒量表

指标类型:

次要指标

Outcome:

Hyperarousal Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医院焦虑抑郁量表

指标类型:

次要指标

Outcome:

Hospital Anxiety and Depression Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血

指标类型:

次要指标

Outcome:

peripheral blood

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群

指标类型:

次要指标

Outcome:

Intestinal flora

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠严重指数量表

指标类型:

次要指标

Outcome:

Insomnia Severity Index

Type:

Secondary 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:

静脉血

Sample Name:

348

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:

肠道菌群

组织:

Sample Name:

Intestinal flora

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:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 60
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

符合标准并签署同意书的参与者将被随机分组。分组随机分为PLWNT组和CBT组,比例为1:1,具体随机化方法如下。一名独立的统计学家用计算机软件程序(Strategic Applications software, version 9.1.3;SAS Institute Inc., Cary, NC, USA)创建随机数表,此随机数字表将发送给一名不参与试验招募或治疗的管理人员。管理人员将把包含患者的身份信息、治疗方法、时间、位置根据随机数放入不透明的信封中储存起来。之后,他们把密闭信封交给研究小组,研究小组将以原始资料形式打印并保存。

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

Participants who meet the criteria and sign a consent form will be randomized. The groups were randomly divided into PLWNT group and CBT group with a ratio of 1:1. The specific randomization method is as follows. An independent statistician uses computer software programs (Strategic Applications software version 9.1.3; SAS Institute Inc. Cary NC USA) creates a table of random numbers that will be sent to an administrator who is not involved in trial recruitment or treatment. The manager will store the patient's identity information treatment methods time and location in an opaque envelope based on random numbers. After that they handed the sealed envelope to the research team which would print it and save it in original form.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

电子邮件:jiahehe158@163.com

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

Email:jiahehe158@163.com

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:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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