ChiCTR2600124714 版本V1.0 版本创建时间2026/05/15 17:18:07 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600124714 

最近更新日期：

Date of Last Refreshed on：

 2026-05-15 17:17:51 

注册时间：

Date of Registration：

 2026-05-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

超声颈部淋巴刺激帮助失眠患者减少安眠药用量的随机对照研究

Public title：

Ultrasound Neck Therapy to Help Insomnia Patients Reduce Sleep Medication Use: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声颈部淋巴刺激辅助失眠患者苯二氮?类药物减量的随机对照临床试验

Scientific title：

Ultrasound Cervical Lymphatic Stimulation for Benzodiazepine Tapering in Insomnia: A Randomized Controlled Trial

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：

段海水 

研究负责人：

段海水 

Applicant：

Haishui Duan 

Study leader：

Haishui Duan 

申请注册联系人电话：

Applicant telephone：

 +86 13896918650

研究负责人电话：

Study leader's
telephone：

+86 23 58328158

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：

 55790061@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 55790061@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：

重庆市万州区新城路165号

研究负责人通讯地址：

重庆市万州区新城路165号

Applicant address：

No. 165 Xincheng Road, Wanzhou District, Chongqing

Study leader's address：

165 Xincheng Road, Wanzhou District, Chongqing

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：

重庆大学附属三峡医院

Applicant's institution：

Chongqing University Three Gorges Hospital

研究负责人所在单位：

重庆大学附属三峡医院（重庆三峡中心医院）

Affiliation of the Leader：

Chongqing University Three Gorges Hospital（Chongqing Three Gorges Central Hospital）

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：

 2026 年科伦审第（60）号

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：

重庆大学附属三峡医院科学研究伦理委员会

Name of the ethic committee：

Ethics Committee of Three Gorges Hospital affiliated to Chongqing University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-28 00:00:00

伦理委员会联系人：

陈利

Contact Name of the ethic committee：

Chen Li

伦理委员会联系地址：

重庆市万州区新城路165号

Contact Address of the ethic committee：

165 Xincheng Road, Wanzhou District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 58103788

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 136176427@qq.com

研究实施负责（组长）单位：

重庆大学附属三峡医院（重庆三峡中心医院）

Primary sponsor：

Chongqing University Three Gorges Hospital（Chongqing Three Gorges Central Hospital）

研究实施负责（组长）单位地址：

重庆市万州区新城路165号

Primary sponsor's address：

165 Xincheng Road, Wanzhou District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆市

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆大学附属三峡医院（重庆三峡中心医院）

具体地址：

重庆市万州区新城路165号

Institution
hospital：

Chongqing University Three Gorges Hospital（Chongqing Three Gorges Central Hospital）

Address：

165 Xincheng Road, Wanzhou District, Chongqing

经费或物资来源：

重庆海扶医疗科技股份有限公司

Source(s) of funding：

Chongqing Haifu Technology Co.,Ltd.

研究疾病：

慢性失眠症  

Target disease：

Sleep disorder

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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的： 评估超声颈部淋巴刺激辅助失眠患者苯二氮?类药物减量的安全性与有效性。 次要目的： 1.评估超声颈部淋巴刺激对睡眠结构与睡眠质量的改善作用； 2.评估超声颈部淋巴刺激对日间功能、情绪状态与生活质量的影响； 3.探索超声颈部淋巴刺激神经生物学标记的变化。  

Objectives of Study：

Main objective:To evaluate the safety and efficacy of ultrasonic neck lymph stimulation in reducing benzodiazepine dosage for patients with insomnia. Secondary objectives:1.To assess the improvement effect of ultrasonic neck lymph stimulation on sleep structure and sleep quality;2.To evaluate the impact of ultrasonic neck lymph stimulation on daytime function, emotional state and quality of life;3. To explore the changes in neurobiological markers of ultrasonic neck lymph stimulation.

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.年龄在18周岁至80周岁之间（含边界值），性别不限； 2.符合《国际睡眠障碍分类第三版（ICSD-3）》中失眠症的诊断标准： (1).主观体验到的睡眠困扰（主诉对夜间睡眠不满意，表现为入睡困难、睡眠维持困难、早醒、适宜时间不肯上床或没有看护难以入睡）； (2).常规卧床时间（睡眠或尝试入睡时间）在6-9小时之间，具有充足的睡眠时间和睡眠环境； (3).日间症状至少一项：疲倦、易怒、工作/学习/社交能力下降等。 3.针对当前睡眠障碍正在接受苯二氮卓类药物治疗，累计治疗周期≥3月，患者减药意愿强烈； 4.能够理解研究流程，愿意遵守研究方案要求，配合完成干预措施及随访评估； 5.自愿参加本研究，并签署书面知情同意书。

Inclusion criteria

1. Aged between 18 and 80 (inclusive), with no gender restrictions; 2. Meet the diagnostic criteria for insomnia as outlined in the International Classification of Sleep Disorders Third Edition (ICSD-3): (1). Subjective experience of sleep disturbance (reporting dissatisfaction with nighttime sleep, manifested as difficulty falling asleep, difficulty maintaining sleep, early awakening, unwillingness to go to bed at an appropriate time, or difficulty falling asleep without supervision); (2). Regular bedtime (sleep or attempted sleep time) between 6-9 hours, with adequate sleep duration and sleep environment; (3). At least one daytime symptom: fatigue, irritability, decreased work/study/social ability, etc. 3.Currently receiving benzodiazepine treatment for sleep disorders, with a cumulative treatment duration of >=3 months, and a strong willingness to reduce medication; 4. Able to understand the research process, willing to comply with the requirements of the research protocol, and cooperate in completing the intervention measures and follow-up assessments; 5. Volunteer to participate in this study and sign a written informed consent form.

排除标准：

1.神经系统疾病急性期：入组前3个月内（或研究期间）处于急性期的严重神经系统疾病，包括但不限于脑梗死、脑出血、癫痫持续状态、颅脑损伤等； 2.具有临床意义的神经系统疾病病史：经研究者判定可能影响研究执行或安全性评价的神经系统疾病史，包括但不限于：(1).既往有癫痫发作史（热性惊厥除外），因苯二氮?类药物减量可能诱发癫痫； (2).头部外伤史：入组前2年内有明确诊断的颅脑损伤、脑震荡后综合征或脑外伤后癫痫； (3).既往脑部手术史：包括开颅手术、脑深部电刺激植入等。 3.精神疾病急性期：目前处于严重精神疾病（如精神分裂症、双相情感障碍、重度抑郁症伴自杀风险、物质滥用依赖、严重焦虑障碍等）的急性发作期，或需要紧急精神科干预者； 4.具有临床意义的精神疾病病史：经研究者判定可能影响研究依从性或安全性的精神疾病史，包括但不限于： (1).任何既往诊断的精神分裂症或分裂情感性障碍； (2).任何既往诊断双相情感障碍； (3).重度抑郁症：既往有反复发作史、伴有自杀行为史或需要住院治疗史； (4).过去2年内有酒精、阿片类、可卡因等物质依赖史（尼古丁除外）； (5).严重焦虑障碍：包括惊恐障碍、广泛性焦虑障碍伴显著功能损害，且近期未得到稳定控制； (6).强迫障碍：目前或既往有严重强迫症状影响日常功能。 5.严重躯体疾病：存在严重或不稳定的系统性疾病，经研究者判断可能影响研究执行的，如不稳定型心绞痛、严重肝肾功能不全、呼吸衰竭等； 6.活动性感染/炎症：存在活动性感染或全身性炎症疾病，经研究者判断可能显著干扰实验室检测结果者； 7.设备使用禁忌证：存在本研究干预设备明确禁忌的情况，包括但不限于：(1).颈部皮肤破损、皮疹、过敏或感染者；(2).体内植入有源电子设备（如心脏起搏器、迷走神经刺激器等）；(3).处于妊娠期或备孕期女性。 8.重度睡眠呼吸暂停综合征：筛选期或既往诊断的重度睡眠呼吸暂停综合征。 9.围绝经期相关睡眠障碍：经研究者判定，睡眠障碍主要由围绝经期综合征引起； 10.已知人类免疫缺陷病毒（HIV）阳性、梅毒感染。 11.其他研究者判断：存在其他任何情况（如认知功能障碍、计划近期搬迁等），研究者认为可能使研究参与者面临风险、干扰研究结果或无法完成整个研究过程者。

Exclusion criteria：

1. Acute phase of neurological diseases: Patients with severe neurological diseases in the acute phase within 3 months before enrollment (or during the study period), including but not limited to cerebral infarction, cerebral hemorrhage, status epilepticus, and craniocerebral injury; 2.Clinically significant history of neurological diseases: History of neurological diseases that, as determined by the investigator, may affect the execution of the study or safety evaluation, including but not limited to: (1). Previous history of seizures (excluding febrile seizures), which may be induced by benzodiazepine withdrawal; (2). History of head trauma: having a clearly diagnosed cranial injury, post-concussion syndrome, or post-traumatic epilepsy within 2 years prior to enrollment; (3).Previous history of brain surgery: including craniotomy, deep brain stimulation implantation, etc; 3. Acute phase of mental illness: Currently experiencing an acute episode of severe mental illness (such as schizophrenia, bipolar disorder, major depressive disorder with suicide risk, substance abuse dependence, severe anxiety disorder, etc.), or requiring emergency psychiatric intervention; 4.Clinically significant history of psychiatric disorders: History of psychiatric disorders that, as determined by the investigator, may affect study compliance or safety, including but not limited to: (1). any previously diagnosed schizophrenia or schizoaffective disorder; (2). any previously diagnosed bipolar disorder; (3). major depressive disorder: history of recurrent episodes, accompanied by a history of suicidal behavior or requiring hospitalization; (4).history of dependence on substances such as alcohol, opioids, and cocaine (excluding nicotine) within the past 2 years; (5). severe anxiety disorder: including panic disorder, generalized anxiety disorder with significant functional impairment, and not having been stably controlled in the recent period; (6). obsessive-compulsive disorder: currently or previously experiencing severe obsessive-compulsive symptoms affecting daily functioning. 5. Severe physical illness: The presence of severe or unstable systemic diseases that, in the judgment of the researcher, may affect the execution of the study, such as unstable angina pectoris, severe hepatic and renal insufficiency, respiratory failure, etc; 6. Active infection/inflammation: Subjects with active infection or systemic inflammatory disease that, in the investigator's judgment, may significantly interfere with laboratory test results; 7.Contraindications for equipment use: There are clear contraindications for the intervention equipment in this study, including but not limited to: (1). individuals with damaged skin, rashes, allergies, or infections on the neck; (2). individuals with implanted active electronic devices (such as cardiac pacemakers, vagus nerve stimulators, etc.); (3). women who are pregnant or in the preparation phase for pregnancy; 8. Severe Obstructive Sleep Apnea Syndrome: Severe Obstructive Sleep Apnea Syndrome diagnosed during the screening period or previously; 9. Peri-menopausal-related sleep disorders: Researchers have determined that sleep disorders are primarily caused by peri-menopausal syndrome; 10. Known to be HIV-positive and infected with syphilis; 11.Other researchers' judgment: In any other circumstances (such as cognitive dysfunction, planning to relocate in the near future, etc.), researchers believe that it may put study participants at risk, interfere with study results, or prevent them from completing the entire study process.

研究实施时间：

Study execute time：

从 From 2026-05-09 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-16 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 45

Group：

Control Group

Sample size：

干预措施：

超声颈部淋巴刺激假干预

干预措施代码：

Intervention：

Ultrasonic cervical lymph node stimulation sham intervention

Intervention code：

组别：

试验组

样本量：

 45

Group：

Experimental Group

Sample size：

干预措施：

超声颈部淋巴刺激干预

干预措施代码：

Intervention：

Ultrasound-stimulated intervention of cervical lymph nodes

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 重庆大学附属三峡医院（重庆三峡中心医院） 

单位级别：

 三级甲等 

Institution
hospital：

Chongqing University Three Gorges Hospital（Chongqing Three Gorges Central Hospital）

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

日间功能

指标类型：

次要指标

Outcome：

Daytime function

Type：

Secondary indicator

测量时间点：

基线、干预与维持干预期每周

测量方法：

采用Epworth嗜睡量表（ESS）在基线、干预与维持干预期每周进行评估，对比两组总分差异及变化值。

Measure time point of outcome：

Baseline, intervention, and maintenance intervention period per week

Measure method：

The Epworth Sleepiness Scale (ESS) was used for weekly assessments at baseline, during the intervention, and during the maintenance intervention period to compare the total score differences and change values between the two groups.

指标中文名：

苯二氮?类药物减量成功率

指标类型：

主要指标

Outcome：

Success rate of benzodiazepine tapering

Type：

Primary indicator

测量时间点：

3个月

测量方法：

通过3个月苯二氮卓类药物减量干预，苯二氮卓类药物剂量减少（剂量减少25%及以上）或停药的患者比例，对比两组差异。

Measure time point of outcome：

three months

Measure method：

After a 3-month intervention involving benzodiazepine dosage reduction, the proportion of patients who either had a reduction in benzodiazepine dosage (by 25% or more) or discontinued the medication was compared between two groups.

指标中文名：

苯二氮?类药物停药率

指标类型：

次要指标

Outcome：

Benzodiazepine withdrawal rate

Type：

Secondary indicator

测量时间点：

不同干预周期

测量方法：

不同干预周期BZRA 停药率，对比两组差异。

Measure time point of outcome：

Different intervention periods

Measure method：

Compare the BZRA discontinuation rates across different intervention periods between the two groups.

指标中文名：

情绪状态

指标类型：

次要指标

Outcome：

Emotional state

Type：

Secondary indicator

测量时间点：

基线、干预与维持干预期每周

测量方法：

采用汉密尔顿焦虑量表（HAMA）和汉密尔顿抑郁量表（HAMD）在基线、干预与维持干预期每周进行评估，对比两组总分差异及变化值。

Measure time point of outcome：

Baseline, intervention, and maintenance intervention periods per week

Measure method：

The Hamilton Anxiety Scale (HAMA) and the Hamilton Depression Scale (HAMD) were used for weekly assessments at baseline, during the intervention, and during the maintenance intervention period, to compare the differences in total scores and changes between the two groups.

指标中文名：

不良事件发生率（%）和发生的频率（事件数目）

指标类型：

主要指标

Outcome：

Adverse event occurrence rate (%) and frequency of occurrence (number of events)

Type：

Primary indicator

测量时间点：

每次干预与维持干预期

测量方法：

临床医生按照不良事件通用术语评价标准，根据患者的临床表现和检验检查结果综合进行判断分级

Measure time point of outcome：

Each intervention and maintenance intervention period

Measure method：

Clinicians comprehensively judge and grade adverse events based on the patient's clinical manifestations and laboratory test results, in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

指标中文名：

苯二氮?类药物减量率

指标类型：

次要指标

Outcome：

Benzodiazepine reduction rate

Type：

Secondary indicator

测量时间点：

不同干预周期

测量方法：

不同干预周期BZRA剂量①减少25%及以上患者比例；②减少50%及以上患者比例；③减少75%及以上患者比例，对比各组差异。

Measure time point of outcome：

Different intervention periods

Measure method：

For different intervention periods, compare the differences in the proportions of patients with BZRA dosages: ① reduced by 25% or more; ② reduced by 50% or more; ③ reduced by 75% or more.

指标中文名：

减药反应发生率以及中重度减药反应的发生率

指标类型：

次要指标

Outcome：

The incidence of drug reduction reactions and the incidence of moderate to severe drug reduction reactions

Type：

Secondary indicator

测量时间点：

干预与维持干预期每周

测量方法：

采用苯二氮?类药物戒断症状问卷（BWSQ）在干预与维持干预期每周进行评估，在两组间进行比较。

Measure time point of outcome：

Intervention and maintenance intervention period per week

Measure method：

The Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) was used to assess weekly during the intervention and maintenance phase, and comparisons were made between the two groups.

指标中文名：

严重不良事件发生率（%）和发生的频率（事件数目）

指标类型：

次要指标

Outcome：

Incidence rate (%) and frequency (number of events) of serious adverse events

Type：

Secondary indicator

测量时间点：

每次干预与维持干预期

测量方法：

临床医生按照不良事件通用术语评价标准，根据患者的临床表现和检验检查结果综合进行判断分级

Measure time point of outcome：

Each intervention and maintenance intervention period

Measure method：

Clinicians comprehensively judge and grade adverse events based on the patient's clinical manifestations and laboratory test results, in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

指标中文名：

器械相关不良事件发生率（%）和发生的频率（事件数目）

指标类型：

次要指标

Outcome：

Incidence rate (%) and frequency (number of events) of device-related adverse events

Type：

Secondary indicator

测量时间点：

每次干预与维持干预期

测量方法：

临床医生按照不良事件通用术语评价标准，根据患者的临床表现和检验检查结果综合进行判断分级

Measure time point of outcome：

Each intervention and maintenance intervention period

Measure method：

Clinicians comprehensively judge and grade adverse events based on the patient's clinical manifestations and laboratory test results, in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

指标中文名：

器械缺陷的发生率（%）和发生的频率（事件数目）

指标类型：

次要指标

Outcome：

The occurrence rate (%) and frequency (number of events) of device defects

Type：

Secondary indicator

测量时间点：

每次干预与维持干预期

测量方法：

临床医生按照不良事件通用术语评价标准，根据患者的临床表现和检验检查结果综合进行判断分级

Measure time point of outcome：

Each intervention and maintenance intervention period

Measure method：

Clinicians comprehensively judge and grade adverse events based on the patient's clinical manifestations and laboratory test results, in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

指标中文名：

睡眠质量评分、失眠严重程度指数量表（ISI）、匹兹堡睡眠质量指数（PSQI）

指标类型：

次要指标

Outcome：

Sleep quality score, Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI)

Type：

Secondary indicator

测量时间点：

每日、每两周、每四周

测量方法：

睡眠日记问卷（SDQ）每日记录睡眠情况，以周均值形式呈现；对比两组干预与维持干预期睡眠质量评分。失眠严重程度指数量表（ISI）每两周进行评估，对比两组ISI总分差异、变化值及应答率。匹兹堡睡眠质量指数（PSQI）每四周进行评估，对比两组总分差异及变化值。

Measure time point of outcome：

Daily, every two weeks, every four weeks

Measure method：

The Sleep Diary Questionnaire (SDQ) records sleep conditions daily and presents them in the form of weekly averages. It compares the sleep quality scores of the two groups during the intervention and maintenance periods. The Insomnia Severity Index (ISI) is assessed every two weeks, and the differences in total ISI scores, change values, and response rates between the two groups are compared. The Pittsburgh Sleep Quality Index (PSQI) is assessed every four weeks, and the differences in total PSQ

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

基线、干预与维持干预期每月

测量方法：

采用SF12健康调查简表急性版在基线、干预与维持干预期每月进行评估，对比两组总分差异及变化值。

Measure time point of outcome：

Baseline, intervention, and maintenance intervention period per month

Measure method：

The SF12 Health Survey Short Form (acute version) was used for assessments at baseline, during the intervention, and at the end of the maintenance intervention period, with a focus on comparing the total score differences and changes between the two groups.

指标中文名：

器械相关严重不良事件发生率（%）和发生的频率（事件数目）

指标类型：

次要指标

Outcome：

Incidence rate of device-related serious adverse events (%) and Frequency of occurrence (number of events)

Type：

Secondary indicator

测量时间点：

每次干预与维持干预期

测量方法：

临床医生按照不良事件通用术语评价标准，根据患者的临床表现和检验检查结果综合进行判断分级

Measure time point of outcome：

Each intervention and maintenance intervention period

Measure method：

Clinicians comprehensively judge and grade adverse events based on the patient's clinical manifestations and laboratory test results, in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

指标中文名：

神经退行性相关生物标志物

指标类型：

次要指标

Outcome：

Neurodegenerative related biomarkers

Type：

Secondary indicator

测量时间点：

基线和干预期、干预结束（B/T4/W2）

测量方法：

于基线和干预期、干预结束（B/T4/W2）采集空腹静脉血，检测以下生物标志物：ptau217，tTau，Aβ42，Aβ40，NFL。探索超声颈部淋巴刺激是否通过增强类淋巴功能影响脑内Aβ和tau蛋白的清除效率，为机制研究提供生物学证据。

Measure time point of outcome：

Baseline, intervention period, and end of intervention (B/T4/W2)

Measure method：

Fasting venous blood was collected at baseline, during the intervention period, and at the end of the intervention (B/T4/W2) to detect the following biomarkers: ptau217, tTau, Aβ42, Aβ40, and NFL. The study explored whether ultrasound cervical lymph stimulation could affect the clearance efficiency of Aβ and tau proteins in the brain by enhancing lymphatic-like function, providing biological evidence for mechanism research.

指标中文名：

睡眠结构客观指标

指标类型：

次要指标

Outcome：

Objective indicators of sleep structure

Type：

Secondary indicator

测量时间点：

基线和末次干预结束后（B/W2）

测量方法：

基于多导睡眠监测（PSG）的监测结果，分析干预前后睡眠结构的变化。PSG监测于基线和末次干预结束后（B/W2）进行。客观评估干预对睡眠生理特征的影响，并与主观睡眠指标进行一致性分析。

Measure time point of outcome：

After the baseline and the end of the last intervention (B/W2)

Measure method：

Based on the monitoring results of polysomnography (PSG), analyze the changes in sleep structure before and after intervention. PSG monitoring was conducted at baseline and after the end of the last intervention (B/W2). Objectively evaluate the impact of intervention on sleep physiological characteristics and perform a consistency analysis with subjective sleep indicators.

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

按照1:1进行随机分组，随机步骤： （1）根据诊断及纳排标准，筛选病例进入试验； （2）登录随机系统网站，录入相关信息（如研究参与者姓名缩写、年龄、性别、联系方式等）后点击确定，系统生成病例的分组结果及相应的随机号； （3）按照分组结果执行方案，若研究参与者使用了错误的组别干预，则不进行纠正，继续原干预，在病历中记录干预的详细情况。

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

Randomly group in a 1:1 ratio. Random steps: (1) According to the diagnostic and inclusion/exclusion criteria, cases are screened to enter the trial. (2) Log in to the random system website, enter relevant information (such as the abbreviation of the research participant's name, age, gender, contact information, etc.) and click OK. The system will generate the grouping results of the cases and the corresponding random numbers. (3) Execute the plan according to the grouping results. If the research participants use the wrong group intervention, no correction will be made and the original intervention will continue. The detailed situation of the intervention will be recorded in the medical record.

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：

单盲，对评估者隐藏分组

Blinding：

Single blind study with blinded-evaluators

是否共享原始数据：

IPD sharing

否No

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）：

无数据共享

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

No data sharing

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：

本研究使用项目合作单位重庆医科大学超声医学工程国家重点实验室建立的真实世界数据管理平台（Real World Data Management Platform， RWDMP） 进行数据采集与管理。RWDMP是基于“治疗——让病人受伤害更少”的理念，覆盖临床科研至慢病管理全流程，支持多模态临床数据存储分析，有效整合纸质/电子病历、影像资料及随访数据，攻克了传统临床资料管理碎片化难题。通过建立标准化临床研究操作规范体系，平台实现数据全流程溯源、权限分级管理和实时备份，数据存储采用校内防火墙保护机制，全面保障医疗数据安全与可控性，显著提升临床研究质量与工作效率。 12.1数据录入 研究者根据研究参与者的原始记录，将数据及时、完整、正确、清晰地载入电子数据采集系统。 12.2数据核查 （1）数据质疑和修改研究中所有观察到的结果和异常发现，均应及时加以认真核实、记录，保证数据的可靠性。 （2）重点核查EDC录入数据与源文件是否一致，包括数值、单位、时间点等，任何修改都必须有痕迹且理由充分。 12.3数据处理 数据库锁定后提交统计分析人员进行统计分析。

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

This study utilizes the Real World Data Management Platform (RWDMP) established by the State Key Laboratory of Ultrasound Medical Engineering at Chongqing Medical University, a project collaborating institution, for data collection and management. RWDMP is based on the concept of "treatment - minimizing patient harm," covering the entire process from clinical research to chronic disease management. It supports multimodal clinical data storage and analysis, effectively integrates paper/electronic medical records, imaging data, and follow-up data, and has overcome the fragmentation challenge of traditional clinical data management. By establishing a standardized clinical research operational specification system, the platform achieves full-process data traceability, hierarchical permission management, and real-time backup. Data storage is protected by an internal firewall mechanism, fully ensuring the security and controllability of medical data, and significantly improving the quality and efficiency of clinical research.12.1 Data entryBased on the original records of the study participants, the researchers promptly, completely, accurately, and clearly entered the data into the electronic data collection system.12.2 Data verification(1) All observed results and abnormal findings in data questioning and modification research should be promptly and carefully verified and recorded to ensure the reliability of the data.(2) Focus on verifying whether the data entered into EDC is consistent with the source documents, including values, units, time points, etc. Any modifications must be traceable and justified.12.3 Data processingAfter the database is locked, submit it to statistical analysts for statistical analysis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-15 17:17:51