ChiCTR2600118376 版本V1.0 版本创建时间2026/02/04 16:41:05 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：

 ChiCTR2600118376 

最近更新日期：

Date of Last Refreshed on：

 2026-02-04 16:41:01 

注册时间：

Date of Registration：

 2026-02-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

中医综合干预联合数字随访失眠相关性研究

Public title：

Comprehensive Traditional Chinese Medicine Intervention Combined with Digital Follow-up: A Correlative Study on Insomnia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中医综合干预联合数字随访失眠相关性研究

Scientific title：

Comprehensive Traditional Chinese Medicine Intervention Combined with Digital Follow-up: A Correlative Study on 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：

孟意琳 

研究负责人：

孟意琳 

Applicant：

Yilin Meng 

Study leader：

Yilin Meng 

申请注册联系人电话：

Applicant telephone：

 +86 178 1686 2849

研究负责人电话：

Study leader's
telephone：

+86 178 1686 2849

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：

 402548973@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 402548973@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：

浙江省杭州市西湖区体育场路453号

研究负责人通讯地址：

浙江省杭州市西湖区体育场路453号

Applicant address：

No. 453, Stadium Road, Xihu District, Hangzhou City, Zhejiang Province

Study leader's address：

No. 453, Stadium Road, Xihu District, Hangzhou City, Zhejiang Province

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：

杭州市中医院

Applicant's institution：

Hangzhou Hospital of Traditional Chinese Medicine

研究负责人所在单位：

杭州市中医院

Affiliation of the Leader：

Hangzhou Hospital of Traditional Chinese Medicine

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：

 2025KLL294

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：

杭州市中医院科研伦理委员会

Name of the ethic committee：

Ethics Committee for Scientific Research, Hangzhou Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-29 00:00:00

伦理委员会联系人：

陈洪宇

Contact Name of the ethic committee：

Hongyu Chen

伦理委员会联系地址：

浙江省杭州市西湖区体育场路453号

Contact Address of the ethic committee：

No. 453, Stadium Road, Xihu District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 180 5712 9786

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：

杭州市中医院

Primary sponsor：

Hangzhou Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

浙江省杭州市西湖区体育场路453号

Primary sponsor's address：

No. 453, Stadium Road, Xihu District, Hangzhou City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

西湖区

Country：

China

Province：

Zhejiang

City：

Xihu

单位(医院)：

杭州市中医院

具体地址：

浙江省杭州市西湖区体育场路453号

Institution
hospital：

Hangzhou Hospital of Traditional Chinese Medicine

Address：

No. 453, Stadium Road, Xihu District, Hangzhou City, Zhejiang Province

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

失眠  

Target disease：

Insomnia

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

1.回顾性分析：梳理既往接受中医综合调摄（起居、情志、五音、导引、饮食、中药辨证）的慢性失眠患者数据，明确患者基本情况（年龄、学历、工作等）、个性特征、睡眠情绪情况等特征及治疗响应规律。 2.干预性研究：通过中医数字疗法（如天天好寐小程序、AI智能人）开展随访管理，验证中医综合调摄对慢性失眠患者睡眠改善、不良情绪缓解及疾病认知提升的长期疗效（随访周期12个月）。 3.方案优化：基于回顾性与干预性研究结果，构建“中医综合调摄+数字随访”的标准化干预流程，为慢性失眠的长期管理提供可推广的中医数字疗法方案。  

Objectives of Study：

1. Retrospective analysis: Data of patients with chronic insomnia who previously received comprehensive TCM regulation (including daily life management, emotional regulation, five-note music therapy, daoyin exercise, dietary adjustment, and TCM syndrome differentiation and treatment) were collated to clarify the patients’ basic characteristics (e.g., age, educational background, occupation), personality traits, sleep and emotional status, as well as the regularity of treatment response. 2. Interventional study: Follow-up management was conducted via TCM digital therapies (e.g., Tiantian Haomei Mini Program, AI intelligent assistant) to verify the long-term efficacy of comprehensive TCM regulation in improving sleep quality, alleviating negative emotions, and enhancing disease cognition among patients with chronic insomnia (12-month follow-up period). 3. Protocol optimization: Based on the results of the retrospective and interventional studies, a standardized intervention process integrating "comprehensive TCM regulation + digital follow-up" was established, aiming to provide a promotable TCM digital therapy scheme for the long-term management 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ICD-10中非器质性失眠症的诊断标准； 2.回顾性研究：有完整的中医综合调摄治疗记录（含干预方案、疗效评估）；干预性研究：匹兹堡睡眠质量指数量表（PSQI）总分>=8分，广泛性焦虑量表（GAD-7）评分≥5分或抑郁症筛查量表（PHQ-9）评分>=5分（存在轻中度焦虑/抑郁）； 3.年龄18-70岁，性别不限； 4.干预性研究：自愿参与数字随访，能熟练使用智能手机应用程序。

Inclusion criteria

1. Meets the diagnostic criteria for non-organic insomnia as defined in ICD-10; 2. Retrospective study: Complete records of comprehensive traditional Chinese medicine therapy (including intervention plan and efficacy assessment); Interventional study: Total score of Pittsburgh Sleep Quality Index (PSQI) >= 8 points, score of Generalized Anxiety Disorder Scale (GAD-7) >= 5 points, or score of Patient Health Questionnaire-9 (PHQ-9) >= 5 points (indicating mild to moderate anxiety/depression); 3. Age 18-70 years old, gender not restricted; 4. Interventional study: Voluntary participation in digital follow-up and proficient in using smartphone applications.

排除标准：

1.继发性失眠（如严重精神疾病、神经系统疾病、内分泌疾病等所致）； 2.重度焦虑/抑郁（GAD-7>=15分或PHQ-9>=15分）或有自杀风险； 3.妊娠期、哺乳期女性； 4.无法配合随访（如认知障碍、严重躯体疾病）者。

Exclusion criteria：

1. Secondary insomnia (caused by severe mental disorders, neurological diseases, endocrine disorders, etc.); 2. Severe anxiety/depression (GAD-7 score >= 15 or PHQ-9 score >= 15) or with suicidal risk; 3. Pregnant or lactating women; 4. Those who cannot cooperate with follow-up (such as cognitive impairment, severe physical diseases).

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-09 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 500

Group：

Experimental group

Sample size：

干预措施：

1.起居调摄：要求患者每日进行睡眠时间打卡，建议患者每晚22：00-23：00睡觉，早上6：00-7：00起床，每日进行睡眠时间打卡。若老年人或者有早醒习惯的人群，可适当提前1小时。此干预不同失眠证型人群都一样； 2.情志调摄：根据不同五志失眠证型设置相应的情志调摄古文各八篇，要求患者每天抄写两遍，阅读十分钟，并记录打卡上传。每篇文章连读三天，第四天按顺序进入下一篇文章（每逢周日停一天）； 3.音乐调摄：根据五行-五志-五音相生相克的关系设置不同音乐，例如针对“怒”性失眠的患者，给予角调阴韵与商调阳韵的音乐，要求患者聆听每日聆听1次，每次聆听15分钟，并打卡记录； 4.运动导引：根据五志-五脏的关系，推荐相应的五禽戏与六字气诀的功法，要求跟随视频，每日至少3次，每次10分钟，并打卡记录； 5.饮食调摄：根据五志-五脏的关系，推荐患者进食相应寒热温凉的食谱，以调节脏腑阴阳平衡，起到治疗效果； 6.中药辨证论治：以张永华情志辨证理论体系为指导，根据证型开具汤剂，每2周复诊调整处方。

干预措施代码：

Intervention：

1. Daily Life Regulation: Patients were required to clock in their sleep duration every day. They were advised to go to bed between 22:00 and 23:00 and get up between 6:00 and 7:00 daily. For elderly patients or those with the habit of early awakening, the schedule could be advanced by 1 hour appropriately. This intervention was uniformly applied to all patients regardless of their insomnia syndrome types. 2. Emotional Regulation: Eight ancient texts of emotional regulation were prepared respectively for insomnia patients with different five-emotion syndrome types. Patients were required to copy each text twice a day, read it for 10 minutes, and then upload the clock-in record. Each text was used continuously for 3 days, and the next text in sequence was adopted on the 4th day (with a one-day suspension every Sunday). 3. Music Regulation: Specific music tracks were configured based on the inter-promoting and inter-restraining relationships among the five elements, five emotions and five notes. For example, patients with insomnia induced by "anger" were provided with Jue-tone (the first note in the Chinese five-tone scale) of Yin rhyme and Shang-tone (the second note) of Yang rhyme. Patients were required to listen to the music once a day for 15 minutes each time and record the clock-in information. 4. Exercise Guidance (Daoyin): Corresponding routines of Wuqinxi (Five-Animal Exercises) and Liuzi Jue (Six-Character Health Preserving Formula) were recommended according to the correlation between the five emotions and five zang-organs. Patients were instructed to follow video tutorials to practice at least 3 times a day, 10 minutes each time, and complete the clock-in record. 5. Dietary Regulation: Diets with corresponding properties (cold, hot, warm, cool) were recommended to patients based on the relationship between the five emotions and five zang-organs, so as to regulate the Yin-Yang balance of zang-fu organs and achieve the therapeutic effect. 6. TCM Syndrome Differentiation and Treatment with Chinese Materia Medica: Guided by Zhang Yonghua’s theoretical system of emotional syndrome differentiation, herbal decoctions were prescribed according to different syndrome types. Patients were required to have a follow-up visit every 2 weeks for prescription adjustment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 杭州市中医院 

单位级别：

 三甲 

Institution
hospital：

Hangzhou Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

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

Type：

Primary indicator

测量时间点：

入组时、干预1个月、3个月、6个月、12个月

测量方法：

量表测评

Measure time point of outcome：

At baseline, 1 month, 3 months, 6 months, and 12 months after intervention

Measure method：

Scale Assessment

指标中文名：

广泛性焦虑障碍量表

指标类型：

主要指标

Outcome：

Generalized Anxiety Disorder-7

Type：

Primary indicator

测量时间点：

入组时、干预1个月、3个月、6个月、12个月

测量方法：

量表测评

Measure time point of outcome：

At baseline, 1 month, 3 months, 6 months, and 12 months after intervention

Measure method：

Scale Assessment

指标中文名：

抑郁筛查量表

指标类型：

主要指标

Outcome：

Patient Health Questiomnare-9

Type：

Primary indicator

测量时间点：

入组时、干预1个月、3个月、6个月、12个月

测量方法：

量表测评

Measure time point of outcome：

At baseline, 1 month, 3 months, 6 months, and 12 months after intervention

Measure method：

Scale Assessment

指标中文名：

睡眠个人信念与态度量表

指标类型：

主要指标

Outcome：

Dysfunctional Beliefs and Attitudes about Sleep Scale

Type：

Primary indicator

测量时间点：

入组时、干预1个月、3个月、6个月、12个月

测量方法：

量表测评

Measure time point of outcome：

At baseline, 1 month, 3 months, 6 months, and 12 months after intervention

Measure method：

Scale Assessment

指标中文名：

中医症候积分

指标类型：

主要指标

Outcome：

TCM Syndrome Score

Type：

Primary indicator

测量时间点：

入组时、干预1个月、3个月、6个月、12个月

测量方法：

量表测评

Measure time point of outcome：

At baseline, 1 month, 3 months, 6 months, and 12 months after intervention

Measure method：

Scale Assessment

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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 18 岁 years
最大 Max age 70 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）：

无

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

None

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：

无

Blinding：

None

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

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

None

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-02-04 16:41:01