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Study on Electrophysiological Mechanism and Intervention Effectiveness of Insomnia Based on Abdominal Acupuncture and tACS Regulation Technology

注册号：

Registration number：

ITMCTR2100004293

最近更新日期：

Date of Last Refreshed on：

2021-01-19

注册时间：

Date of Registration：

2021-01-19

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于腹针和tACS调控技术的失眠症电生理机制及干预有效性研究

Public title：

Study on Electrophysiological Mechanism and Intervention Effectiveness of Insomnia Based on Abdominal Acupuncture and tACS Regulation Technology

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于腹针和tACS调控技术的失眠症电生理机制及干预有效性研究

Scientific title：

Study on Electrophysiological Mechanism and Intervention Effectiveness of Insomnia Based on Abdominal Acupuncture and tACS Regulation Technology

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：

ChiCTR2100042343 ; ChiMCTR2100004293

申请注册联系人：

王婧

研究负责人：

王婧

Applicant：

Wang Jing

Study leader：

Wang Jing

申请注册联系人电话：

Applicant telephone：

+86 15910525655

研究负责人电话：

Study leader's telephone：

+86 15910525655

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：

happyksg@126.com

研究负责人电子邮件：

Study leader's E-mail：

happyksg@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：

北京市海淀区玉泉路15号

研究负责人通讯地址：

北京市海淀区玉泉路15号

Applicant address：

15 Yuquan Road, Haidian District, Beijing.

Study leader's address：

15 Yuquan Road, Haidian District, Beijing.

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：

航天中心医院健康管理部

Applicant's institution：

Department of Health Management, Aerospace Center Hospital, Peking University Aerospace School of Clinical 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：

20201010-QTKT-01

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

航天中心医院伦理委员会

Name of the ethic committee：

Ethics Committee of Aerospace Center Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2020/10/10 0:00:00

伦理委员会联系人：

李云杉

Contact Name of the ethic committee：

Li Yunshan

伦理委员会联系地址：

航天中心医院办公楼211

Contact Address of the ethic committee：

Office 211, Office Buildings, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing.

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10-59971956

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

北京市海淀区航天中心医院健康管理部

Primary sponsor：

Department of Health management, Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine

研究实施负责（组长）单位地址：

北京市海淀区玉泉路15号

Primary sponsor's address：

15 Yuquan Road, Haidian District, Beijing.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

航天中心医院

具体地址：

海淀区玉泉路15号

Institution
hospital：

Aerospace Center Hospital

Address：

15 Yuquan Road, Haidian District

经费或物资来源：

首都卫生发展科研专项、航天医疗健康科技集团有限公司科研基金

Source(s) of funding：

Capital Health Development Research Project, Aerospace Medical Health Technology Group Co., Ltd. Research Fund

研究疾病：

失眠及药物依赖性失眠

研究疾病代码：

Target disease：

Insomnia and drug-dependent 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：

探索性研究/预试验

Pilot clinical trial

研究目的：

1.主要目标 （1）确定原发性失眠及EDIAD的脑电特征标志； （2）探讨基于tACS调控技术的原发性失眠症电生理机制研究； （3）探讨基于腹针联合减药疗法的EDIAD电生理机制研究。 2.次要目标 （1）基于睡眠-觉醒神经回路和原发性失眠的异常神经网络，为原发性失眠的治疗提供精准tACS干预策略； （2）评价精准仿真定位计算辅助下tACS治疗原发性失眠的有效性及安全性； （3）评价腹针联合减药疗法治疗EDIAD的有效性及安全性。

Objectives of Study：

1. Main objectives (1) to determine the EEG characteristics of primary insomnia and EDIAD; (2) To explore the electrophysiological mechanism of primary insomnia based on tACS regulation technology; (3) to explore the electrophysiological mechanism of EDIAD based on abdominal acupuncture combined with drug reduction therapy; 2. Secondary objectives (1) Based on the sleep-wake neural circuit and the abnormal neural network of primary insomnia, provide accurate tACS intervention strategy for the treatment of primary insomnia; (2) To evaluate the effectiveness and safety of tACS in the treatment of primary insomnia with the assistance of precise simulation and positioning calculation; (3) to evaluate the effectiveness and safety of abdominal acupuncture combined with drug reduction therapy in treating EDIAD.

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）健康对照组 年龄18-65岁；无睡眠障碍历史；PSQI<7；良好的睡眠质量，无昼夜交替工作时间的历史；没有神经或精神疾病，例如抑郁症和焦虑症（HAMD≤7，HAMA＜7）；无其他睡眠障碍；惯用右手。 （2）原发性失眠患者组 ① 符合失眠诊断标准，惯用右手； ② 病人意识清醒，无失语、智能障碍，能理解量表内容并配合治疗； ③ 兹堡睡眠质量指数量表(Pittsburgh sleep quality index, PSQI)总分≥7 分； ④ 无严重器质性疾病如心血管疾病、肝肾功能不全以及精神病等； ⑤ 年龄在18-65岁，愿接受本方案治疗且坚持治疗者； ⑥ 志愿参加，签署知情同意书。 ⑦ 汉密尔顿焦虑量表（HAMA）得分≤14； ⑧ 汉密尔顿抑郁量表（HAMD）得分≤17。 （3）EDIAD患者组 ①符合失眠的中西医诊断标准及催眠药物依赖性睡眠障碍诊断标准,服用艾司唑仑1-2mg≥6个月，惯用右手； ②病人意识清醒，无失语、智能障碍，能理解量表内容并配合治疗； ③兹堡睡眠质量指数量表(Pittsburgh sleep quality index,PSQI)总分≥7 分； ④无严重器质性疾病如心血管疾病、肝肾功能不全以及精神病等； ⑤年龄在40-65岁，愿接受本方案治疗且坚持治疗者； ⑥志愿参加,签署知情同意书。 ⑦汉密尔顿焦虑量表（HAMA）总分7-21分； ⑧汉密尔顿抑郁量表（HAMD）总分＞7分，≤17分。

Inclusion criteria

1. Healthy control group Aged 18-65 years; No history of sleep disorder; PSQI<7 Good sleep quality, no history of alternating working hours between day and night; No neurological or mental diseases, such as depression and anxiety (HAMD≤7, HAMA < 7); No other sleep disorders; Right-handed. 2. Patients with primary insomnia (1) meet the diagnostic criteria of insomnia, right-handed; (2) The patient is conscious, without aphasia and intelligence disorder, and can understand the contents of the scale and cooperate with the treatment; (3) The total score of Pittsburgh Sleep Quality Index (PSQI) is >= 7; (4) There are no serious organic diseases such as cardiovascular diseases, hepatic and renal insufficiency and mental illness. (5) Those aged 18-65 who are willing to accept this treatment and insist on treatment; (6) Volunteer to participate and sign informed consent. (7) Hamilton Anxiety Scale (HAMA) score <= 14; (8) Hamilton Depression Scale (HAMD) score <= 17. 3. Patients with EDIAD (1) Meet the diagnostic criteria of Chinese and Western medicine for insomnia and hypnotic drug-dependent sleep disorder, take estazolam for 1-2mg >= 6 months, and use your right hand; (2) The patient is conscious, without aphasia and intelligence disorder, and can understand the contents of the scale and cooperate with the treatment; (3) The total score of Pittsburgh Sleep Quality Index (PSQI) is >= 7; (4) There are no serious organic diseases such as cardiovascular diseases, hepatic and renal insufficiency and mental illness. (5) Those aged 40-65 who are willing to accept this treatment and insist on treatment; (6) Volunteer to participate and sign informed consent. (7) The total score of Hamilton Anxiety Scale (HAMA) is 7-21; (8) The total score of Hamilton Depression Scale (HAMD) is > 7 and <= 17.

排除标准：

(1)原发性失眠患者组 ① 使用其它治疗失眠药物者； ② 药物、应急事件、环境和心理因素、不良习惯引起的失眠； ③ 严重神经衰弱患者，应激障碍、人格障碍及器质性疾病和精神活性物质所引起的失眠； ④ 观察期内生活环境（客观）将有较大变化者； ⑤ 严重肝、肾功能不全，或合并各系统严重疾病者； ⑥ 由于距离远或其他原因不能坚持治疗者； ⑦ 孕妇、哺乳期妇女等特殊人群；符合上述任意一条者均不能入组。 (2)EDIAD患者组 ①使用艾司唑仑以外的其它治疗失眠药物者； ②药物、应急事件、环境和心理因素、不良习惯引起的失眠； ③严重神经衰弱患者，应激障碍、人格障碍及器质性疾病和精神活性物质所引起的失眠； ④根据研究者判断，具有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，经常出差等； ⑤孕妇、哺乳期妇女、高热、凝血功能障碍者； ⑥严重肝、肾功能不全，或合并各系统严重疾病者； ⑦酗酒或有其它物质依赖； ⑧由于距离远或其他原因不能坚持治疗者； ⑨外用酒精过敏或对针灸针过敏者；腹腔内脏器疾病或腹部疤痕等影响在腹部施针者；采用其他治疗方案或参加其它临床研究的患者； 符合上述任意一条者均不能入组。

Exclusion criteria：

Patients with primary insomnia (1) do not meet the above conditions; ② Those who use other drugs to treat insomnia; ③ Insomnia caused by drugs, emergency events, environmental and psychological factors and bad habits; ④ Insomnia caused by severe neurasthenia, stress disorder, personality disorder, organic diseases and psychoactive substances; ⑤ The living environment (objectively) will change greatly during the observation period; ⑥ Severe liver and kidney insufficiency, or serious diseases of various systems; ⑦ Those who cannot insist on treatment due to long distance or other reasons; 8 pregnant women, lactating women and other special groups; Those who meet any of the above items are not allowed to join the group. Group of EDIAD patients (1) do not meet the above conditions; ② Those who use drugs other than estazolam to treat insomnia; ③ Insomnia caused by drugs, emergency events, environmental and psychological factors and bad habits; ④ Insomnia caused by severe neurasthenia, stress disorder, personality disorder, organic diseases and psychoactive substances; ⑤ According to the researcher's judgment, there are other situations that have the possibility of low enrollment or complicate enrollment, such as frequent changes in the working environment and frequent business trips; 6 pregnant women, lactating women, high fever, coagulation dysfunction; ⑦ Severe hepatic and renal insufficiency, or complicated with serious diseases of various systems; ⑧ Alcoholism or other material dependence; Pet-name ruby due to distance or other reasons can't insist on treatment; Attending external use of alcohol allergy or allergic to acupuncture needles; Abdominal organ diseases or abdominal scars affect those who apply needles in the abdomen; Patients who adopt other treatment schemes or participate in other clinical studies; Those who meet any of the above items are not allowed to join the group.

研究实施时间：

Study execute time：

从From 2020-01-01

至To      2022-12-31

征募观察对象时间：

Recruiting time：

从From 2021-02-01

至To      2022-09-30

干预措施：

Interventions：

组别：

健康对照组

样本量：

66

Group：

Healthy control group

Sample size：

干预措施：

无

干预措施代码：

。

Intervention：

No

Intervention code：

组别：

腹针试验组

样本量：

62

Group：

Abdominal acupuncture test group

Sample size：

干预措施：

减药疗法+腹针疗法

干预措施代码：

。

Intervention：

Drug reduction therapy+abdominal acupuncture therapy

Intervention code：

组别：

伪刺激对照组

样本量：

66

Group：

shamstimulation control group

Sample size：

干预措施：

伪刺激

干预措施代码：

.

Intervention：

sham stimulus

Intervention code：

组别：

真刺激试验组

样本量：

66

Group：

True stimulation test group

Sample size：

干预措施：

电刺激

干预措施代码：

。

Intervention：

Electrical stimulation

Intervention code：

组别：

假针刺对照组

样本量：

62

Group：

sham acupuncture control group

Sample size：

干预措施：

减药疗法+假针刺

干预措施代码：

.

Intervention：

Drug reduction therapy+sham acupuncture

Intervention code：

样本总量 Total sample size ： 322

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

航天中心医院

单位级别：

三级综合医院

Institution/hospital：

Aerospace Center Hospital

Level of the institution：

Tertiary general hospital

测量指标：

Outcomes：

指标中文名：

艾司唑仑服药量

指标类型：

主要指标

Outcome：

Dosage of estazolam

Type：

Primary indicator

测量时间点：

第0、1、2、3、4、8周

测量方法：

记录

Measure time point of outcome：

Week 0, 1, 2, 3, 4 and 8

Measure method：

Record

指标中文名：

汉密尔顿焦虑量表

指标类型：

次要指标

Outcome：

Hamilton Anxiety Scale

Type：

Secondary indicator

测量时间点：

第0、4、8周

测量方法：

量表

Measure time point of outcome：

Week 0, 4 and 8

Measure method：

Scale

指标中文名：

汉密尔顿抑郁量表

指标类型：

次要指标

Outcome：

Hamilton Depression Scale

Type：

Secondary indicator

测量时间点：

第0、4、8周

测量方法：

量表

Measure time point of outcome：

Week 0, 4 and 8

Measure method：

Scale

指标中文名：

苯二氮?类药物戒断症状问卷

指标类型：

次要指标

Outcome：

Benzodiazepine Withdrawal Symptom Questionnaire

Type：

Secondary indicator

测量时间点：

第0、4、8周

测量方法：

量表

Measure time point of outcome：

Week 0, 4 and 8

Measure method：

Scale

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：

第0、4、8周

测量方法：

量表

Measure time point of outcome：

Week 0, 4 and 8

Measure method：

Scale

指标中文名：

艾司唑仑减药率

指标类型：

主要指标

Outcome：

Drug reduction rate of estazolam

Type：

Primary indicator

测量时间点：

第0、1、2、3、4、8周

测量方法：

记录+计算

Measure time point of outcome：

Week 0, 1, 2, 3, 4 and 8

Measure method：

Record+calculate

指标中文名：

脑电

指标类型：

次要指标

Outcome：

EEG

Type：

Secondary indicator

测量时间点：

第0、4、8周

测量方法：

量表

Measure time point of outcome：

Week 0, 4 and 8

Measure method：

Scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

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：

正在进行

Recruiting

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）：

采用SAS9.3统计分析软件的“Proc plan”程序产生研究所需的随机序列。

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

The "Proc plan" program of SAS9.3 statistical analysis software was used to generate the random sequence needed for the study.

盲法：

原发性失眠患者组：采用双盲设计，对所用人员均设盲。提前将2台相同的tACS仪器（无创经颅电刺激器GS220）分别按真伪刺激组要求设置参数，伪刺激对照组输出锁定为0。将2台仪器随机放入两个环境相同的治疗室，被试患者按随机分组结果进入对应治疗室接受治疗，操作者按相同的操作流程完成真伪刺激组的治疗。 EDIAD患者组：将入组的EDIAD患者随机分成腹针试验组及假针刺对照组两组，只通知患者在不同的治疗室进行治疗。患者、结局评价者及锁定数据库后对第三方统计师均进行盲法。

Blinding：

Patients with primary insomnia: A double-blind design was adopted, and all the patients were blind. Two identical tACS instruments (non-invasive transcranial electrical stimulator GS220) were set in advance according to the requirements of true and false stimulation group, and the output of false stimulation control group was locked to 0. Two instruments were randomly placed in two treatment rooms with the same environment, the patients were randomly grouped into the corresponding treatment rooms for treatment, and the operators completed the treatment of true or false stimulation group according to the same operation flow. Patients with EDIAD: the patients with EDIAD were randomly divided into abdominal acupuncture test group and sham acupuncture control group, and were only informed to treat in different treatment rooms. Patients, outcome evaluators and third-party statisticians are blind after locking the database.

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）：

暂无 请阅读网页注册指南中关于“共享原始数据”的内容

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

Not stated

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：

1.病例报告表的记录要求 （1）全部病例，无论是符合试验方案的病例还是脱落病例，均应按本方案规定认真填写《病例报告表》。主要研究者应对试验数据的真实性负责。 （2）原始化验单必须齐全并粘贴在《病例报告表》中，记录的实验室检查数据或描述，要与原始检验报告核对无误，监查员应对此负责。 （3）对实验室检查项目在临床可接受范围以外的数据，研究者均应加以核实，属于非试验疾病或非允许合并的疾病所致者，应及时复查，确属异常者，治疗前不能入选，治疗后要追访至正常。 （4）所有 CRF 由研究护士（或研究生）直接录入，所有电子CRF经过研究者审核并电子签名批准后生效。 2.数据录入及核对 （1）本研究产生的数据将由两名数据录入员进行双录入、双核查。经过研究者签名后生效。 （2）数据录入以每周为节点，有关数据管理人员进行数据的逻辑核查，有疑问处及时向研究者反应，并予患者沟通确认，以保证数据真实可靠。 （3）全部病例数据录入完成后，由主要研究者、统计分析人员和监查员在盲态下对数据进行最后审核。 （4）数据审核会议 会上数据管理人员、统计人员、研究者、临床监查员等相关人员对下列项目进行讨论：受试者分布、方案违背、可能离群值、基线特征、疗效指标、统计分析计划定稿。

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

1. Record requirements of the case report form (1) All cases, whether in accordance with the test plan or dropped cases, should carefully fill in the Case Report Form according to the provisions of this plan. The main researcher should be responsible for the authenticity of the test data. (2) The original laboratory test sheet must be complete and pasted in the Case Report Form. The recorded laboratory test data or description should be checked with the original test report, and the supervisor should be responsible for it. (3) The data of laboratory examination items outside the clinically acceptable range should be verified by researchers. Those who are caused by non-experimental diseases or diseases that are not allowed to merge should be reviewed in time. Those who are abnormal should not be selected before treatment, and should be followed up to normal after treatment. (4) All CRFs are entered directly by research nurses (or graduate students), and all electronic CRFs will come into effect after being examined by researchers and approved by electronic signatures. 2. Data entry and check (1) The data generated in this study will be entered and checked by two data entry staff. It will take effect after being signed by the researcher. (2) Data entry takes every week as the node, and relevant data management personnel carry out logical verification of data, and respond to researchers in time when there is any doubt, and communicate with patients for confirmation, so as to ensure the authenticity and reliability of data. (3) After the data entry of all cases is completed, the main researchers, statistical analysts and monitors will conduct final review of the data in the blind state. (4) At the data review meeting, data managers, statisticians, researchers, clinical monitors and other relevant personnel discussed the following items: subject distribution, scheme violation, possible outliers, baseline characteristics, curative effect indicators, and final statistical analysis plan.

数据管理委员会：

Data Managemen Committee：

有

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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