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Observation on the characteristics and therapeutic effects of infrared thermography in people with different characteristics of insomnia

注册号：

Registration number：

ITMCTR2025001186

最近更新日期：

Date of Last Refreshed on：

2025-06-16

注册时间：

Date of Registration：

2025-06-16

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

失眠不同特征人群红外热成像特点及治疗效应观察

Public title：

Observation on the characteristics and therapeutic effects of infrared thermography in people with different characteristics of insomnia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

失眠不同特征人群红外热成像特点及治疗效应观察

Scientific title：

Observation on the characteristics and therapeutic effects of infrared thermography in people with different characteristics of insomnia

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：

申雨川

研究负责人：

杨志敏

Applicant：

Yuchuan Shen

Study leader：

Zhimin Yang

申请注册联系人电话：

Applicant telephone：

17665003130

研究负责人电话：

Study leader's telephone：

13822296363

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：

3299688419@qq.com

研究负责人电子邮件：

Study leader's E-mail：

yangyoVIP@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：

广东省广州市白云区广州中医药大学三元里校区

研究负责人通讯地址：

广东省广州市越秀区大德路广东省中医院治未病科

Applicant address：

Sanyuanli Campus Guangzhou University of Traditional Chinese Medicine Baiyun District Guangzhou City Guangdong Province China

Study leader's address：

No.111 Dade Road Yuexiu District Guangzhou City Guangdong Province 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：

广东省广州市越秀区大德路111号

Applicant's institution：

No.111 Dade Road Yuexiu District Guangzhou City Guangdong Province China

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：

YE2025-161-01

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：

广东省中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/5/8 0:00:00

伦理委员会联系人：

李晓彦

Contact Name of the ethic committee：

Li Xiao Yan

伦理委员会联系地址：

广东省中医院

Contact Address of the ethic committee：

Guangdong Hospital of Traditional Chinese Medicine

伦理委员会联系人电话：

Contact phone of the ethic committee：

02081887233

伦理委员会联系人邮箱：

Contact email of the ethic committee：

llbgs@gzucm.edu.cn

研究实施负责（组长）单位：

广东省中医院

Primary sponsor：

Guangdong Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

广东省广州市越秀区大德路111号广东省中医院研修楼七楼

Primary sponsor's address：

No.111 Dade Road Yuexiu District Guangzhou City Guangdong 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)：

广东

市(区县)：

广州

Country：

China

Province：

Guang Dong

City：

Guangzhou

单位(医院)：

广东省中医院

具体地址：

广东省广州市越秀区大德路111号广东省中医院研修楼七楼

Institution
hospital：

Guangdong Hospital of Traditional Chinese Medicine

Address：

No.111 Dade Road Yuexiu District Guangzhou City Guangdong Province China

经费或物资来源：

广东省中医院

Source(s) of funding：

Guangdong Hospital of Traditional Chinese Medicine

研究疾病：

失眠

研究疾病代码：

G47.001

Target disease：

insomnia

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

病例对照研究

Case-Control study

研究所处阶段：

Study phase：

其它

Others

研究目的：

1.建立失眠热化人群与失眠寒化人群的红外热成像数据库，探索各组人群之间的红外热成像差异。 2.基于红外热成像技术，揭示中药治疗对失眠不同特征人群体表热力学分布的影响规律，探索红外热成像特征参数作为中医"气-血"状态可视化表征的客观证据。通过建立动态热图与治疗效应的定量关系，为阐明中药作用机制提供生物物理学依据，同时研发基于红外热成像的疗效动态监测技术体系，推动中医药疗效评价向客观化、数字化方向发展。

Objectives of Study：

1. To establish infrared thermography databases of people with insomnia heat and people with insomnia cold and to explore the differences in infrared thermography between the groups. 2. Based on infrared thermography reveal the influence of Chinese medicine treatment on the thermodynamic distribution of the body surface of people with different characteristics of insomnia and explore the characteristic parameters of infrared thermography as the objective evidence of the visualization of "qi-blood" state of traditional Chinese medicine. By establishing the quantitative relationship between dynamic thermograms and therapeutic effects we can provide a biophysical basis for elucidating the mechanism of action of traditional Chinese medicines and at the same time we can develop a dynamic monitoring technology system of therapeutic efficacy based on infrared thermography so as to promote the evaluation of the therapeutic efficacy of traditional Chinese medicines in the direction of objectivity and digitalization.

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 18岁-60 岁。 ② 符合西医慢性失眠诊断标准。 ③ 符合中医不寐诊断和失眠寒化人群及失眠热化人群中的任意一种（见后附1）。 ④ 失眠严重程度指数(ISI)总分>7 分。 ⑤ 签署知情同意书。 附1：中医诊断标准：参照中华人民共和国中医药行业标准《中医内科病证诊断疗效标准》(ZY/T001.1-94)中有关不寐的诊断标准。 ① 失眠寒化人群诊断标准 主症：神疲乏力。 次症：畏冷或怕风，肢凉，心悸，头晕，自汗，月经量少，下眼睑淡白或淡白夹边红。 舌脉：舌质淡，脉弱或细或沉。 主症必备，次症具备2项及以上，舌象、脉象具备，不具备以下症状中的2项及以上:明显的口干、口苦或口臭，易咽喉肿痛或易口腔溃疡，易紧张焦虑，手心潮热，大便灼热干结，下眼睑偏红。即可诊断。 ② 失眠热化人群诊断标准 主症：易咽痛或易口腔溃疡或痤疮或发热。 次症：手心潮热，口干、口臭或口苦，易紧张或易焦虑，大便灼热或干结，小便灼热，下眼睑偏红或唇色暗红或唇偏干，脉息比>5。 舌脉：舌质红、苔少或苔黄，脉动或浊或弦或数。 主症必备，次症具备2项及以上，舌象、脉象具备，不具备以下症状中的2项及以上:口淡乏味，受凉后易腹泻、便溏，下肢水肿触诊手脚冰凉，刻下喷嚏流清涕，下眼睑淡白或淡白夹边红。即可诊断。

Inclusion criteria

① 18-60 years old. ② Meet the diagnostic criteria of chronic insomnia in Western medicine. ③ Meet the diagnosis of insomnia in Chinese medicine and any one of the insomnia chilling and insomnia heating groups (see Attachment 1). ④ Insomnia Severity Index (ISI) score >7. ⑤ Signed informed consent. Attachment 1: Diagnostic criteria of Chinese medicine: refer to the diagnostic criteria of insomnia in the standard of Chinese medicine industry of the People's Republic of China "Diagnostic and therapeutic efficacy criteria of Chinese medicine internal medicine illnesses" (ZY/T001.1-94). ① Diagnostic Criteria for Insomnia in Cold-Chemical Population Primary symptom: fatigue. Secondary symptoms: fear of cold or wind cold limbs palpitation dizziness spontaneous sweating scanty menstruation pale lower eyelids or pale white with red edges. Tongue and pulse: pale tongue weak or fine or dull pulse. The primary symptom must be present two or more of the secondary symptoms are present the tongue and pulse are present but two or more of the following symptoms are not present: obvious dry mouth bitter mouth or halitosis easy to sore throat or easy to mouth ulcers easy to be nervous and anxious hot flashes in the palms of the hands burning and dry stools and redness in the lower eyelids. The diagnosis can be made. ② Diagnostic Criteria for Insomnia Heating People Primary symptoms: easy sore throat or easy mouth ulcers or acne or fever. Secondary symptoms: hot flashes on the palms of the hands dry mouth bad breath or bitter taste in the mouth easy to be nervous or anxious burning or dry stools burning urine reddish lower eyelids or dark red lips or dry lips pulse rate >5. Tongue and pulse: red tongue scanty or yellowish coating moving or cloudy or stringy or numbered pulse. The primary symptom must be present the secondary symptom has 2 or more the tongue and pulse are present and 2 or more of the following symptoms are not present: pale and insipid mouth easy diarrhea and loose stools after being cold oedema of the lower limbs cold hands and feet on palpation sneezing and sneezing under the carving and the lower eyelids are pale white or pale white with red edges. It can be diagnosed.

排除标准：

① 准备怀孕或孕期或哺乳期或需要陪伴小孩一起睡觉的人群; ② 根据病史与问诊，医生确认由其它疾病引起的继发性失眠。例如:局部的疼痛、不安腿综合征、睡眠呼吸暂停综合征、急慢性心力衰竭、慢性阻塞性肺病、急慢性支气管炎等; ③ 根据患者抑郁自评工具(PHQ-9)诊断为中、重度抑郁患者(总分>10); ④ 根据广泛性焦虑量表(GAD-7)诊断中、重度焦虑患者(总分>10); ⑤ 合并有心脑血管、肺、肝、肾和内分泌系统等严重疾病者; ⑥ 精神发育迟滞者、酒精或物质滥用或依赖、自杀倾向者; ⑦ 过去 30 天内参加过其它药物临床试验者; ⑧ 合并其他精神疾病者; ⑨ 排除其他不能长期合作者; ⑩ 根据病史与问诊，医生确认为需要按照疾病管理方式管理的患者。

Exclusion criteria：

①Preparing to become pregnant or during pregnancy or breastfeeding or those who need to sleep with their children. ② Secondary insomnia caused by other illnesses as confirmed by the doctor based on medical history and consultation. For example: localized pain restless leg syndrome sleep apnea syndrome acute and chronic heart failure chronic obstructive pulmonary disease acute and chronic bronchitis etc.; ③ According to the patient's depression self-assessment tool the patient may be suffering from insomnia. (iii) Patients diagnosed as moderately or severely depressed (total score >10) according to the Patient Depression Self-Assessment Tool (PHQ-9). ④ Patients with moderate or severe anxiety (total score >10) according to the Generalized Anxiety Disorder Scale (GAD-7); ⑤ Patients with a combination of cardiovascular and cerebrovascular disease (GVD); ⑤ Patients with a combination of cardiovascular and cerebrovascular disease (GVD). ⑤ Patients with a combination of cardiovascular cerebrovascular pulmonary hepatic renal and endocrine system and other serious diseases; ⑥ Patients with mental retardation mental retardation and other serious diseases. (6) Persons with mental retardation alcohol or substance abuse or dependence or suicidal tendency. (vii) Those who have participated in clinical trials of other drugs within the past 30 days; (viii) Those with other mental illnesses. (viii) Those who have participated in clinical trials of other drugs within the past 30 days; (ix) Those who have a combination of other mental illnesses (ix) Exclude those who are unable to cooperate for a long period of time; (x) Exclude those who are unable to cooperate for a long time. ⑩ Patients who are recognized by the physician as requiring disease management based on medical history and consultation.

研究实施时间：

Study execute time：

从From 2025-05-08

至To      2027-05-08

征募观察对象时间：

Recruiting time：

从From 2025-07-25

至To      2025-10-01

干预措施：

Interventions：

组别：

失眠寒化人群

样本量：

60

Group：

Insomnia chilling people

Sample size：

干预措施：

红外热成像检测

干预措施代码：

Intervention：

Infrared Thermal Imaging Inspection

Intervention code：

组别：

失眠热化人群

样本量：

60

Group：

Insomnia Thermalized People

Sample size：

干预措施：

红外热成像检测

干预措施代码：

Intervention：

Infrared Thermal Imaging Inspection

Intervention code：

样本总量 Total sample size ： 120

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广东省中医院

单位级别：

3A

Institution/hospital：

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution：

3A

测量指标：

Outcomes：

指标中文名：

失眠严重指数量表（ISI）

指标类型：

主要指标

Outcome：

Insomnia Severity Index

Type：

Primary indicator

测量时间点：

0w，4w

测量方法：

Measure time point of outcome：

0w,4w

Measure method：

指标中文名：

脉息比

指标类型：

次要指标

Outcome：

Pulse to Respiration Ratio

Type：

Secondary indicator

测量时间点：

0w，4w

测量方法：

Measure time point of outcome：

0w4w

Measure method：

指标中文名：

抑郁症筛查工具

指标类型：

次要指标

Outcome：

Patient Health QuestionnairePHQ-9

Type：

Secondary indicator

测量时间点：

0w,4w

测量方法：

Measure time point of outcome：

0w,4w

Measure method：

指标中文名：

广泛性焦虑障碍量表

指标类型：

次要指标

Outcome：

Generalized Anxiety Disorder Scale

Type：

Secondary indicator

测量时间点：

0w，4w

测量方法：

Measure time point of outcome：

0w4w

Measure method：

指标中文名：

红外热成像检测

指标类型：

主要指标

Outcome：

Infrared Thermal Imaging Inspection

Type：

Primary indicator

测量时间点：

0w，4w

测量方法：

Measure time point of outcome：

0w4w

Measure method：

指标中文名：

匹兹堡睡眠质量指数表

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality IndexPSQI

Type：

Secondary indicator

测量时间点：

0w,4w

测量方法：

Measure time point of outcome：

0w,4w

Measure method：

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

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 60 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）：

无

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

none

盲法：

Blinding：

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）：

无

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

No data availablen

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：

数据录入采用Epidata数据库，采用SPSS Statistics 24.0软件进行统计分析。计量资料符合正态分布以均数±标准差( x±SD ) 描述，不符合正态分布以中位数和四分位数描述，对于正态分布资料，两组独立样本组间比较采用两独立样本t检验或t’检验（方差不齐时）（Independent－Samples T Test），对于非正态分布资料，两组独立样本组间比较采用秩和检验（Non-parametric Tests 2 Independent-sample）（Wilcoxon法）。所有的统计检验均采用双侧检验，P值＜0.05被认为有统计学差异。

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

Data entry was performed using the Epidata database and SPSS Statistics 24.0 software was used for statistical analysis. Measurement data conforming to normal distribution were described by mean±standard deviation ( x±SD ) and those not conforming to normal distribution were described by median and quartiles. For normally distributed data comparisons between two independent samples were performed using the two independent samples t-test or the t'test (in case of heteroscedasticity) (Independent-Samples T Test) and for non-normally distributed data comparisons between two independent-sample groups were made using the rank-sum test (Non-parametric Tests 2 Independent-sample) (Wilcoxon method). All statistical tests were two-sided and a P value <0.05 was considered statistically different.

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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