中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500106222
最近更新日期： Date of Last Refreshed on：	2025-07-21 09:41:40
注册时间： Date of Registration：	2025-07-21 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	高压低频静电物理治疗改善慢性失眠障碍的临床疗效及脑电脑氧代谢耦合机制研究
Public title：	A Study on the Clinical Efficacy and Brain EEG–Oxygen Metabolism Coupling Mechanism of High-Voltage Low-Frequency Electrostatic Therapy in Chronic Insomnia
注册题目简写：
English Acronym：
研究课题的正式科学名称：	高压低频静电物理治疗改善慢性失眠障碍的临床疗效及脑电脑氧代谢耦合机制研究
Scientific title：	A Study on the Clinical Efficacy and Brain EEG–Oxygen Metabolism Coupling Mechanism of High-Voltage Low-Frequency Electrostatic Therapy in Chronic Insomnia
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：	毛玉瑢	研究负责人：	毛玉瑢
Applicant：	Mao Yurong	Study leader：	Mao Yurong
申请注册联系人电话： Applicant telephone：	+86 181 4855 0136	研究负责人电话： Study leader's telephone：	+86 755 8120 6511
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：	maoyr@mail.sysu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	maoyr@mail.sysu.edu.cn
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：	广东省深圳市光明区圳园路628号	研究负责人通讯地址：	广东省深圳市光明区圳园路628号
Applicant address：	No. 628, Zhenyuan Road, Xinhu Subdistrict, Guangming District, Shenzhen, Guangdong, China	Study leader's address：	No. 628, Zhenyuan Road, Xinhu Subdistrict, Guangming District, Shenzhen, Guangdong, 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：	中山大学附属第七医院
Applicant's institution：	The Seventh Affiliated Hospital ，Sun Yat-sen University
研究负责人所在单位：	中山大学附属第七医院
Affiliation of the Leader：	The Seventh Affiliated Hospital Sun Yat-sen University

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：	KY-2025-257-02	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	中山大学附属第七医院科研伦理委员会
Name of the ethic committee：	Ethics approval Certificate of the Medical Ethics Committee of the Seventh Affiliated Hospital, Sun Yat-sen University
伦理委员会批准日期： Date of approved by ethic committee：	2025-05-21 00:00:00
伦理委员会联系人：	唐燕
Contact Name of the ethic committee：	yan Tang
伦理委员会联系地址：	广东省深圳市光明区圳园路628号
Contact Address of the ethic committee：	No. 628, Zhenyuan Road, Xinhu Subdistrict, Guangming District, Shenzhen, Guangdong, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 755 81207260	伦理委员会联系人邮箱： Contact email of the ethic committee：	tangyan2@sysush.com

研究实施负责（组长）单位：

中山大学附属第七医院

Primary sponsor：

The Seventh Affiliated Hospital Sun Yat-sen University

研究实施负责（组长）单位地址：

广东省深圳市光明区圳园路628号

Primary sponsor's address：

No. 628, Zhenyuan Road, Xinhu Subdistrict, Guangming District, Shenzhen, Guangdong, 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)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学附属第七医院	具体地址：	深圳市光明新区光明街道光桥路东侧、圳园路628号
Institution hospital：	The?Seventh?Affiliated?Hospital?Sun?Yat-sen?University	Address：	No628 Zhenyuan Road Guangming New District Shenzhen 518107 China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-financed research

研究疾病：

慢性失眠症，临床症状表现为入睡困难、睡眠维持困难或早醒、睡眠质量下降和总睡眠时间少于6.5小时，症状每周至少出现3次，并伴有日间功能受损。引起的日间功能障碍主要包括疲劳、情绪低落或易激惹、躯体不适、认知障碍、焦虑情绪等。

Target disease：

Chronic insomnia is clinically characterized by difficulty falling asleep, difficulty maintaining sleep or early morning awakening, reduced sleep quality, and a total sleep duration of less than 6.5 hours. These symptoms occur at least three times per week and are accompanied by daytime functional impairments. The resulting daytime dysfunction mainly includes fatigue, low mood or irritability, som

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

探索性研究/预试验

Study phase：

0

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

研究高压低频静电治疗对失眠患者睡眠质量的改善以及对轻、中度失眠严重程度者的干预效果，并通过脑电（EEG）活动和功能性近红外（fNIRS）脑氧变化的结局指标分析，明确睡眠质量及改善与大脑神经电活动及传递机制的关联性。此外，也探索高压低频静电治疗改善失眠患者伴焦虑、抑郁的结局。

Objectives of Study：

This study aims to investigate the effects of high-voltage low-frequency electrostatic therapy on improving sleep quality in patients with insomnia, as well as its intervention efficacy in patients with mild to moderate insomnia. By analyzing outcome measures related to electroencephalogram (EEG) activity and cerebral oxygenation changes using functional near-infrared spectroscopy (fNIRS), the study seeks to clarify the relationship between sleep quality improvement and neural electrical activity and transmission mechanisms in the brain. Additionally, the study explores the effects of the therapy on comorbid anxiety and depression symptoms in patients with 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：

Inclusion criteria

1. Subjects aged 25 to 65 years with mild to moderate insomnia, with a disease duration of 3 months to 10 years;
2. Subjects who meet the diagnostic criteria for chronic insomnia based on the International Classification of Sleep Disorders, Third Edition (ICSD-3), characterized by difficulty initiating sleep, maintaining sleep, or early morning awakening, accompanied by daytime functional impairment, with a duration of >=3 months;
3. Insomnia severity categorized as mild to moderate (Insomnia Severity Index [ISI] score between 8 and 21; Pittsburgh Sleep Quality Index [PSQI] score between 6 and 15);
4. Ability to maintain sitting or lying position for more than 40 minutes;
5. No history of uncontrolled severe physical illness or active psychiatric disorders. Subjects with stable and well-controlled chronic diseases (e.g., under long-term medication) may be included if their condition does not interfere with adherence to the study protocol or the safety of the intervention, and if insomnia is not the primary manifestation—subject to investigator assessment;
6. Capable of undergoing and tolerating EEG and fNIRS assessments;
7. Voluntarily signs the written informed consent form.

排除标准：

1.不符合上述诊断标准和纳入标准的患者；
2.伴有活动期或未控制的精神疾病，如重度抑郁、双相障碍、精神分裂症等（轻中度、稳定控制的情绪障碍且不作为失眠主要病因的患者，如符合纳入标准，可考虑纳入）；
3.其他原发性睡眠障碍，如阻塞性睡眠呼吸暂停综合征、不宁腿综合征等；
4.急性期或进展期神经系统疾病，如帕金森病、癫痫、脑卒中等；
5.近期接受过脑刺激治疗，如经颅磁刺激（TMS）、电刺激（tDCS）等；
6.未控制的严重心血管或代谢疾病，如未控制的高血压、糖尿病、甲状腺功能异常等；
7.有活动性严重并发症及各种器质性疾病，如严重感染、肝肾功能不全、肿瘤等；
8.经期、备孕、妊娠或哺乳期女性；
9.有电流过敏者；
10.有家族性遗传睡眠障碍者；
11.无法完成随访或依从性差的个体；
12.无法判断疗效或资料不全等影响疗效或安全性判断者；
13.体内有心脏起搏器、心脏支架或其他金属植入物的医疗器械者；
14.入组前已开始本试验方案系统干预1周以上者；或正在接受不稳定或影响睡眠评估的药物治疗（稳定服用且不影响睡眠评估的常规药物可保留，但需记录）。

Exclusion criteria：

1. Individuals who do not meet the above diagnostic or inclusion criteria; 2. Presence of active or uncontrolled psychiatric disorders, including but not limited to major depressive disorder, bipolar disorder, and schizophrenia. Subjects with mild to moderate, stable, and well-controlled mood disorders may be considered if insomnia is not the primary cause and inclusion criteria are met; 3. Diagnosed with other primary sleep disorders, such as obstructive sleep apnea syndrome or restless legs syndrome; 4. Presence of acute or progressive neurological conditions, such as Parkinson’s disease, epilepsy, or recent stroke; 5. History of receiving brain stimulation therapies (e.g., transcranial magnetic stimulation [TMS], transcranial direct current stimulation [tDCS]) within a recent period; 6. Uncontrolled severe cardiovascular or metabolic diseases, including uncontrolled hypertension, diabetes, thyroid dysfunction, etc.; 7. Presence of active severe complications or organic diseases such as severe infections, liver or kidney dysfunction, tumors, etc.; 8. Women who are menstruating, trying to conceive, pregnant, or breastfeeding; 9. Known hypersensitivity or intolerance to electrical stimulation; 10. Family history of hereditary sleep disorders; 11. Poor compliance or inability to complete study visits and follow-up assessments; 12. Individuals whose data are incomplete or whose conditions are deemed by the investigator to interfere with the evaluation of efficacy or safety; 13. Presence of implanted medical devices such as pacemakers, cardiac stents, or other metallic implants; 14. Subjects who have already initiated similar intervention protocols more than one week prior to enrollment, or are receiving unstable pharmacologic treatment that may affect sleep assessment. (Stable medications not affecting sleep evaluation may be continued, but must be documented.);

研究实施时间：

Study execute time：

从 From 2025-07-25 00:00:00至 To 2027-05-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-07-25 00:00:00 至 To 2027-04-30 00:00:00

干预措施：

Interventions：

组别：	试验组（A组）	样本量：	55
Group：	Test group (Group A)	Sample size：	55
干预措施：	高压低频静电治疗	干预措施代码：
Intervention：	High-Voltage Therapy	Intervention code：

组别：	对照组（B组）	样本量：	55
Group：	Control group(Group B)	Sample size：	55
干预措施：	假高压低频静电治疗	干预措施代码：
Intervention：	Sham High-Voltage Therapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学附属第七医院	单位级别：	三级甲等
Institution hospital：	The?Seventh?Affiliated?Hospital?Sun?Yat-sen?University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	功能近红外光谱	指标类型：	次要指标
Outcome：	Functional Near-Infrared Spectroscopy (fNIRS)	Type：	Secondary indicator
测量时间点：	对试验组和对照组在治疗前、治疗2周后	测量方法：	针对脑氧的变化，使用功能近红外光谱设备进行测量。
Measure time point of outcome：	In both the treatment and control groups, assessments were conducted at baseline and after two weeks	Measure method：	Cerebral oxygenation changes: Measured using functional near-infrared spectroscopy (fNIRS);

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 (PSQI)	Type：	Primary indicator
测量时间点：	对试验组和对照组在治疗前、治疗2周后	测量方法：	针对睡眠质量的测量，使用匹兹堡睡眠质量指数量表进行测量。
Measure time point of outcome：	In both the treatment and control groups, assessments were conducted at baseline and after two weeks	Measure method：	Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI).

指标中文名：	抑郁自评量表	指标类型：	次要指标
Outcome：	Self-Rating Depression Scale (SDS)	Type：	Secondary indicator
测量时间点：	对试验组和对照组在治疗前、治疗2周后	测量方法：	针对抑郁的测量，使用抑郁自评量表进行测量。
Measure time point of outcome：	In both the treatment and control groups, assessments were conducted at baseline and after two weeks	Measure method：	Depression was assessed using the Self-Rating Depression Scale (SDS).

指标中文名：	失眠严重程度指数	指标类型：	次要指标
Outcome：	Insomnia Severity Index (ISI)	Type：	Secondary indicator
测量时间点：	对试验组和对照组在治疗前、治疗2周后	测量方法：	针对失眠严重程度的变化，使用失眠严重程度指数量表进行测量。
Measure time point of outcome：	In both the treatment and control groups, assessments were conducted at baseline and after two weeks	Measure method：	Changes in insomnia severity were assessed using the Insomnia Severity Index (ISI).

指标中文名：	脑电图	指标类型：	主要指标
Outcome：	Electroencephalogram (EEG)	Type：	Primary indicator
测量时间点：	对试验组和对照组在治疗前、治疗2周后	测量方法：	针对脑电波的产业化，使用脑电图进行测量。
Measure time point of outcome：	In both the treatment and control groups, assessments were conducted at baseline and after two weeks	Measure method：	Changes in brainwave activity were measured using electroencephalography (EEG) equipment.

指标中文名：	焦虑自评量表	指标类型：	次要指标
Outcome：	Self-Rating Anxiety Scale (SAS)	Type：	Secondary indicator
测量时间点：	对试验组和对照组在治疗前、治疗2周后	测量方法：	针对焦虑的测量，使用了焦虑自评量表进行测量。
Measure time point of outcome：	In both the treatment and control groups, assessments were conducted at baseline and after two weeks	Measure method：	Anxiety was assessed using the Self-Rating Anxiety Scale (SAS).

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	25	岁 years
最大 Max age	65	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

安排一个组员负责招募受试者，进行初筛纳入符合标准受试者，按数字随机表法分为试验组（A组）和对照组（B组）。

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

A designated investigator will be responsible for subject recruitment and preliminary screening. Eligible participants will be randomly assigned into the intervention group (Group A) or the control group (Group B) using a digital randomization table.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	双盲；对研究参与者和评估人员设盲。
Blinding：	Double blind; Blinding research participants and evaluators.

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）：	2027年12月之后，通过本平台公开
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After December 2027, published through this platform.
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：	数据采集和管理使用纸质版病例记录表。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection and management will be conducted using paper-based Case Report Forms.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-07-21 09:41:24