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“醒脑开窍”针法调节大脑皮层兴奋性改善亚健康患者失眠的临床研究

注册号：

Registration number：

ITMCTR2025000774

最近更新日期：

Date of Last Refreshed on：

2025-04-17

注册时间：

Date of Registration：

2025-04-17

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

“醒脑开窍”针法调节大脑皮层兴奋性改善亚健康患者失眠的临床研究

Public title：

Clinical Study on the Effect of "Xingnao Kaiqiao" Acupuncture on Regulating Cerebral Cortex Excitability to Improve Insomnia in Sub-healthy Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“醒脑开窍”针法调节大脑皮层兴奋性改善亚健康患者失眠的临床研究

Scientific title：

Clinical Study on the Effect of "Xingnao Kaiqiao" Acupuncture on Regulating Cerebral Cortex Excitability to Improve Insomnia in Sub-healthy Patients

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：

侯天舒

研究负责人：

侯天舒

Applicant：

Hou Tianshu

Study leader：

Hou Tianshu

申请注册联系人电话：

Applicant telephone：

+86 138 8068 5086

研究负责人电话：

Study leader's telephone：

+86 138 8068 5086

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：

houtianshu@cdutcm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

houtianshu@cdutcm.edu.cn

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：

四川省成都市高新区万象北路18号

研究负责人通讯地址：

四川省成都市高新区万象北路18号

Applicant address：

No. 18 Wanxiang North Road Gaoxin District Chengdu Sichuan Province China

Study leader's address：

No. 18 Wanxiang North Road Gaoxin District Chengdu Sichuan Province China

申请注册联系人邮政编码：

Applicant postcode：

610075

研究负责人邮政编码：

Study leader's postcode：

610075

申请人所在单位：

成都市中西医结合医院

Applicant's institution：

Chengdu Integrated TCM&Western Medicine Hospital

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：

2024KT006

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：

成都市中西医结合医院医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of Chengdu Integrated Traditional Chinese and Western Medicine Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/1/17 0:00:00

伦理委员会联系人：

吴平

Contact Name of the ethic committee：

Wu Ping

伦理委员会联系地址：

四川省成都市高新区万象北路18号

Contact Address of the ethic committee：

No. 18 Wanxiang North Road Gaoxin District Chengdu Sichuan Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 85311468

伦理委员会联系人邮箱：

Contact email of the ethic committee：

houtianshu@cdutcm.edu.cn

研究实施负责（组长）单位：

成都市中西医结合医院

Primary sponsor：

Chengdu Integrated TCM&Western Medicine Hospital

研究实施负责（组长）单位地址：

四川省成都市高新区万象北路18号

Primary sponsor's address：

No. 18 Wanxiang North Road Gaoxin District Chengdu Sichuan Province 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)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan Province

City：

Chengdu

单位(医院)：

成都市中西医结合医院

具体地址：

四川省成都市高新区万象北路18号

Institution
hospital：

Chengdu Integrated TCM&Western Medicine Hospital

Address：

No. 18 Wanxiang North Road Gaoxin District Chengdu Sichuan Province China

经费或物资来源：

成都市卫健委科研项目经费及医院配套

Source(s) of funding：

Chengdu Municipal Health Commission Research Project Funding and Hospital Matching Funds

研究疾病：

失眠

研究疾病代码：

Target disease：

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：

亚健康失眠是人体处于健康低质状态下、对自身睡眠质量不满足的一种主观体验，是亚健康状态最常见的表现之一，其发病率高，发病群体广且逐渐年轻化，人体长期处于亚健康失眠状态，会影响到日常的生活、工作、学习与社会交往等，且可引起其他躯体性亚健康表现如疲劳、疼痛等，甚至出现心理性、社会适应性和思想道德性等亚健康的种种表现症状，因此是亟待解决的社会问题。本课题在我课题组前期科研项目研究结果基础上，进一步利用现代经颅磁技术，根据国医大师石学敏院士“醒脑开窍”针法的基础理论研究、针灸临床数据研究及经验总结，选取我中心常见病亚健康失眠患者，进行随机对照临床试验。观察治疗前后中医证候、睡眠质量变化情况、匹斯堡睡眠质量指数、焦虑自评量表、抑郁自评量表等临床疗效评估并进行大脑皮层兴奋性检测等相关分析，观察临床疗效、并进行脑内促眠机制的探析，以期为临床诊疗提供新思路，为疾病研究提供脑内机制的理论依据。探索构建中医特色心身类疾病完整诊疗体系，结合传统中医与现代诊疗技术，为中医防治心身类疾病提供新的诊疗方向，为亚健康状态临床及脑内机制相关研究提供科学依据。

Objectives of Study：

Sub-health insomnia is a subjective experience where individuals are dissatisfied with their sleep quality while in a low-quality health state. It is one of the most common manifestations of sub-health conditions characterized by high prevalence a broad affected population and a trend toward younger age groups. Prolonged sub-health insomnia can negatively impact daily life work study and social interactions. It may also lead to other physical sub-health symptoms such as fatigue and pain and even psychological social adaptability and ideological-moral sub-health manifestations. Therefore it is a pressing social issue that needs to be addressed. Building on the results of our team's previous research projects this study further utilizes modern transcranial magnetic stimulation technology. Based on the theoretical research clinical acupuncture data and empirical summaries of the "awakening and orifice-opening" acupuncture technique by Academician Shi Xuemin a master of traditional Chinese medicine we selected patients with sub-health insomnia a common condition at our center for a randomized controlled clinical trial. We observed changes in traditional Chinese medicine (TCM) syndromes sleep quality Pittsburgh Sleep Quality Index (PSQI) Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) before and after treatment. Additionally we conducted relevant analyses including cortical excitability tests to evaluate clinical efficacy and explore the brain's sleep-promoting mechanisms. The aim is to provide new insights for clinical diagnosis and treatment offer theoretical foundations for disease research and explore the construction of a comprehensive TCM-based diagnosis and treatment system for psychosomatic diseases. By integrating traditional Chinese medicine with modern diagnostic and therapeutic technologies we hope to provide new directions for the prevention and treatment of psychosomatic diseases in TCM and offer scientific evidence for clinical research on sub-health conditions and related brain mechanisms.

药物成份或治疗方案详述：

治疗组：选取内关、三阴交、尺泽、委中、神门、百会、安眠；患者取仰卧位，先刺双侧内关，直刺15-25mm，施捻转与提插相结合泻法，捻针角度大于180°，捻转频率控制在40-60转/分，施术1分钟。针刺三阴交，沿胫骨内侧缘与皮肤呈45°角斜刺，进针15-30mm，采用提插补法，针感至足趾为度。针刺尺泽穴时，应将屈肘为内角120°，直刺20-25mm，针尖向内偏斜，做提插泻法，待针感从肘关节传导至手指为度。仰卧直腿屈髋取委中穴，针尖稍向外偏斜，进针25-30mm，采用提插泻法，得气并有下肢放射感为度；其余均正常针刺，得气为度，留针30分钟。 对照组：选取内关、三阴交、尺泽、委中、神门、百会、安眠；患者取仰卧位，先刺双侧内关，直刺15-25mm，施捻转与提插相结合泻法，捻针角度大于180°，捻转频率控制在40-60转/分，施术1分钟。针刺三阴交，沿胫骨内侧缘与皮肤呈45°角斜刺，进针15-30mm，采用提插补法，针感至足趾为度。针刺尺泽穴时，应将屈肘为内角120°，直刺20-25mm，针尖向内偏斜，做提插泻法，待针感从肘关节传导至手指为度。仰卧直腿屈髋取委中穴，针尖稍向外偏斜，进针25-30mm，采用提插泻法，得气并有下肢放射感为度；其余均正常针刺，得气为度，留针30分钟。 药物对照组：采用目前使用最多的苯二氮卓类药物（benzodiazepines，BZDs），选取艾司唑仑为治疗药物。受试者晚上睡前30min口服艾司唑仑片1mg（山东信谊制药有限公司），每日１次。

Description for medicine or protocol of treatment in detail：

Experimental group:The following acupoints were selected: Neiguan (PC6) Sanyinjiao (SP6) Chize (LU5) Weizhong (BL40) Shenmen (HT7) Baihui (GV20) and Anmian (Extra). The patient was placed in a supine position. First bilateral Neiguan points were needled perpendicularly to a depth of 15-25 mm using a reducing method that combines twisting and lifting-thrusting techniques. The needle was twisted at an angle greater than 180° with a frequency of 40-60 twists Control group:Select acupoints: Neiguan (PC6) Sanyinjiao (SP6) Chize (LU5) Weizhong (BL40) Shenmen (HT7) Baihui (GV20) Anmian (Extra).Patient assumes supine position. Begin by needling bilateral Neiguan (PC6) perpendicularly 15-25mm deep applying reducing technique combining rotation (over 180° at 40-60 rotations/minute) with lifting-thrusting for 1 minute. For Sanyinjiao (SP6) insert needle at 45° angle along medial tibial border 15-30mm deep using tonifying lifting-thrusting technique until sensation reaches toes. At Chize (LU5) flex elbow to 120° insert needle perpendicularly 20-25mm deep with slight medial inclination apply reducing lifting-thrusting technique until sensation spreads from elbow to fingers.For Weizhong (BL40) with patient supine and leg straight with slight hip flexion insert needle 25-30mm deep with slight lateral inclination apply reducing lifting-thrusting technique until obtaining deqi with radiation down leg. Other points are needled conventionally until deqi is achieved. Retain all needles for 30 minutes. Medication control group:The most commonly used benzodiazepines (BZDs) were employed with estazolam selected as the treatment drug. Participants were instructed to take 1 mg of estazolam tablets (manufactured by Shandong Xinyi Pharmaceutical Co. Ltd.) orally 30 minutes before bedtime once daily.

纳入标准：

1.同时符合亚健康状态和失眠的诊断标准，病情持续3个月以上者； （1）亚健康诊断标准参照2006年《亚健康中医临床指南》中亚健康的判断标准: ① 以疲劳，或睡眠紊乱，或疼痛等躯体症状表现为主; ② 抑郁寡欢，或焦躁不安、急躁易怒，或恐惧胆怯，或短期记忆力下降、注意力不能集中等精神心理症状表现为主; ③以人际交往频率减低，或人际关系紧张等社会适应能力下降表现为主。 上述3条中的任何一条持续发作3个月以上，并且经系统检查排除可能导致上述表现的疾病者。 （2）失眠诊断标准:参照《人民卫生出版社·神经病学·第二版》 ①失眠主诉，包括入睡困难(30分钟不能入睡)，易醒(超过2次)，多梦，早醒或醒后入睡困难(30分钟不能再入睡)等; ② 社会功能受损，白天头昏、乏力、疲劳思睡、注意涣散、工作能力下降；3上述症状每周出现3次以上，持续至少1个月。 2.阿森斯失眠量表评分>7分; 3.年龄在18—65岁;不限性别；经医学伦理委员会审核批准，自愿签署知情同意书。

Inclusion criteria

Participants must meet the diagnostic criteria for both sub-health status and insomnia with the condition persisting for more than 3 months. (1) The diagnostic criteria for sub-health status are based on the 2006 *Clinical Guidelines for Sub-health in Traditional Chinese Medicine*: ① Predominant physical symptoms such as fatigue sleep disturbances or pain; ② Predominant psychological symptoms such as depression anxiety irritability fear short-term memory decline or difficulty concentrating; ③ Predominant decline in social adaptability such as reduced frequency of social interactions or strained interpersonal relationships. Any one of the above three conditions lasting for more than 3 months with systemic examinations ruling out other diseases that may cause these manifestations. (2) The diagnostic criteria for insomnia are based on the *People's Medical Publishing House·Neurology·Second Edition*: ① Complaints of insomnia including difficulty falling asleep (taking more than 30 minutes to fall asleep) frequent awakenings (more than twice per night) vivid dreams early morning awakenings or difficulty falling back asleep after waking up (taking more than 30 minutes to fall back asleep); ② Impaired social functioning with daytime symptoms such as dizziness fatigue sleepiness difficulty concentrating and reduced work performance; ③ The above symptoms occur more than 3 times per week and persist for at least 1 month. 2.2 Athens Insomnia Scale score > 7; 2.3 Age between 18 and 65 years; no gender restrictions; approved by the medical ethics committee and voluntary signing of informed consent.

排除标准：

（1）妊娠或哺乳期妇女或不能表达自己感觉者； （2）合并严重心、肝、肾功能不全，有严重心脏疾病者； （3）近2周内曾接受过任何相关治疗； （4）有药物、酒精滥用史，精神疾病史； （5）颅内置有金属异物者，带有内置脉冲发生器、心脏起搏器、植入式药物泵、植入性除颤器和植入性神经刺激器等体内植入型仪器者，有耳蜗植入者； （6）有颅骨缺损者，颅内压升高者，听力障碍者，有癫痫病史及癫痫家族史者 （7）拒绝或中途退出本次研究，未签署知情同意书者。

Exclusion criteria：

(1) Pregnant or lactating women or individuals unable to express their own sensations; (2) Those with severe cardiac hepatic or renal dysfunction or severe heart disease; (3) Individuals who have received any relevant treatment within the past 2 weeks; (4) Those with a history of drug or alcohol abuse or a history of mental illness; (5) Individuals with metal implants in the skull or those with implanted devices such as pulse generators cardiac pacemakers implantable drug pumps implantable defibrillators or implantable neurostimulators as well as those with cochlear implants; (6) Individuals with skull defects increased intracranial pressure hearing impairment or a personal or family history of epilepsy; (7) Those who refuse to participate withdraw midway from the study or fail to sign the informed consent

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2026-01-01

征募观察对象时间：

Recruiting time：

从From 2025-01-01

至To      2025-02-15

干预措施：

Interventions：

组别：

药物对照组

样本量：

30

Group：

Medication control group

Sample size：

干预措施：

口服苯二氮卓类药物

干预措施代码：

Intervention：

Oral benzodiazepine medications

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

常规针刺

干预措施代码：

Intervention：

Conventional acupuncture

Intervention code：

组别：

实验组

样本量：

30

Group：

Experimental group

Sample size：

干预措施：

“醒脑开窍”针刺

干预措施代码：

Intervention：

"Xingnao Kaiqiao" Acupuncture

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan Province

City：

Chengdu

单位(医院)：

成都市中西医结合医院

单位级别：

三甲

Institution/hospital：

Chengdu Integrated TCM&Western Medicine Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

中医证候改善标准

指标类型：

次要指标

Outcome：

Standard for Improvement of TCM Syndromes

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self-Rating Anxiety 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：

大脑皮层兴奋性

指标类型：

次要指标

Outcome：

Cerebral Cortex Excitability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹斯堡睡眠质量指数

指标类型：

主要指标

Outcome：

Pittsburgh Sleep Quality IndexPSQI

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

睡眠效率

指标类型：

次要指标

Outcome：

sleep efficiency

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抑郁自评量表

指标类型：

次要指标

Outcome：

Self-Rating Depression Scale

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：

无

组织：

无

Sample Name：

No

Tissue：

No

人体标本去向

其它

说明

无

Fate of sample 

Others

Note：

No

征募研究对象情况：

结束

Completed

年龄范围：

最小 18 岁
Min age years
最大 65 岁
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）：

本试验使用 SPSS 26.0 统计软件制成随机数字表，将符合入组条件的患者，按照其入组时间的先后顺序进行编号，根据生成的数字表随机分为试验组与对照组。

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

In this trial the SPSS 26.0 statistical software was utilized to generate a random number table. Patients who met the inclusion criteria were sequentially numbered according to their enrollment time and then randomly assigned to either the experimental group or the control group based on the generated number table.

盲法：

本课题由于针刺研究的特殊性，故难以完成“双盲”，但仍应贯彻“盲法”精神，遵循盲法精神的分离原则，选择不告知患者治疗方案及组别，并保证治疗操作人员和数据抄录人员、评估数据人员三分离。

Blinding：

Due to the unique characteristics of acupuncture research this study faces challenges in achieving "double-blinding." However the principle of blinding shall still be implemented through separation protocols: patients will not be informed of their treatment regimen or group assignment while ensuring three-way separation between treatment operators data recorders and outcome assessors.

是否共享原始数据：

IPD sharing：

是

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）：

本研究的原始数据将在试验结束并完成主要结果发表后，根据合理请求进行共享。共享的数据包括去识别化后的患者基线资料、实验室检查结果、影像学资料及随访数据。数据获取需向研究团队提交正式申请，说明数据使用目的，并签署数据使用协议。数据共享仅限于非商业用途的学术研究，且需获得伦理委员会的批准。数据将通过安全的机构内部系统或加密文件传输方式提供。数据共享将严格遵守伦理委员会的要求和相关隐私保护法规。

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

The raw data from this study will be shared upon reasonable request after the trial concludes and the primary outcomes have been published. The shared data will include de-identified patient baseline information, laboratory test results, imaging data, and follow-up data. Access to the data requires submitting a formal application to the research team, detailing the purpose of data use, and signing a data use agreement. Data sharing is restricted

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：

本研究的数据将通过电子数据采集系统（EDC）和纸质病例报告表（CRF）相结合的方式进行采集。数据来源包括患者病历、实验室检查结果、影像学资料及患者填写的问卷调查。数据采集时间点为基线、治疗5次后、治疗10次后及治疗后4周。为确保数据质量，采用双人独立录入和逻辑核查机制。数据将存储在机构内部加密服务器中，并定期备份至安全云存储平台。访问权限仅限于研究团队成员，且实行分级管理。数据清理过程中将对缺失值和异常值进行核查和处理，数据分析将使用SPSS 26.0软件完成。试验结束后，数据将保留5年，之后通过安全方式销毁。数据共享需提交正式申请并获得伦理委员会批准，共享范围限于去识别化后的数据，且仅用于非商业用途的学术研究。

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

The data for this study will be collected through a combination of an electronic data capture (EDC) system and paper-based case report forms (CRFs). Data sources include patient medical records laboratory test results imaging data and patient-completed questionnaires. Data collection time points are at baseline after 5 treatments after 10 treatments and 4 weeks post-treatment. To ensure data quality a dual independent entry and logical verification mechanism will be implemented. Data will be stored on an encrypted internal institutional server and regularly backed up to a secure cloud storage platform. Access will be restricted to research team members and managed hierarchically. During data cleaning missing values and outliers will be checked and addressed. Data analysis will be performed using SPSS 26.0 software. After the trial concludes the data will be retained for 5 years and then securely destroyed. Data sharing requires submission of a formal application and approval from the ethics committee. Shared data will be limited to de-identified information and used exclusively for non-commercial academic research purposes.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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