ChiCTR2600116914 版本V1.0 版本创建时间2026/01/16 14:13:05 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：

ChiCTR2600116914 

最近更新日期：

Date of Last Refreshed on：

2026-01-16 14:12:59 

注册时间：

Date of Registration：

2026-01-16 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

认知行为疗法治疗突发性耳聋伴耳鸣患者的疗效分析

Public title：

Analysis of the therapeutic effect of Cognitive Behavioral therapy on Patients with Sudden deafness accompanied by Tinnitus

注册题目简写：

认知行为疗法治疗突发性耳聋伴耳鸣患者的疗效分析

English Acronym：

Analysis of the therapeutic effect of Cognitive Behavioral therapy on Patients with Sudden deafness accompanied by Tinnitus

研究课题的正式科学名称：

认知行为疗法治疗突发性耳聋伴耳鸣患者的疗效分析

Scientific title：

Analysis of the therapeutic effect of Cognitive Behavioral therapy on Patients with Sudden deafness accompanied by Tinnitus

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：

孟沙 

研究负责人：

孟沙 

Applicant：

Meng Sha 

Study leader：

Meng Sha 

申请注册联系人电话：

Applicant telephone：

+86 158 8146 1100

研究负责人电话：

Study leader's telephone：

+86 158 8146 1100

申请注册联系人传真 ：

Applicant Fax：

15881461100

研究负责人传真：

Study leader's fax：

15881461100

申请注册联系人电子邮件：

Applicant E-mail：

852267997@qq.com

研究负责人电子邮件：

Study leader's E-mail：

852267997@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：

中国四川省德阳市旌阳区泰山北路173号

研究负责人通讯地址：

中国四川省德阳市旌阳区泰山北路173号

Applicant address：

173 Taishan North Road, Jingyang District, Deyang , Sichuan , China

Study leader's address：

173 Taishan North Road, Jingyang District, Deyang , Sichuan , China

申请注册联系人邮政编码：

Applicant postcode：

618000

研究负责人邮政编码：

Study leader's postcode：

618000

申请人所在单位：

德阳市人民医院

Applicant's institution：

People's Hospital of Deyang city

研究负责人所在单位：

德阳市人民医院

Affiliation of the Leader：

People's Hospital of Deyang city

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-04-131-K01

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：

德阳市人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of People's Hospital of Deyang city

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-12 00:00:00

伦理委员会联系人：

赵小军

Contact Name of the ethic committee：

Zhao Xiaojun

伦理委员会联系地址：

中国四川省德阳市旌阳区泰山北路173号

Contact Address of the ethic committee：

173 Taishan North Road, Jingyang District, Deyang , Sichuan , China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 838 241 5060

伦理委员会联系人邮箱：

Contact email of the ethic committee：

lunli2312773@163.com

研究实施负责（组长）单位：

德阳市人民医院

Primary sponsor：

People's Hospital of Deyang city

研究实施负责（组长）单位地址：

四川省德阳市旌阳区泰山北路173号

Primary sponsor's address：

173 Taishan North Road, Jingyang District, Deyang , Sichuan , 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)：

四川

市(区县)：

德阳

Country：

China

Province：

Sichuan

City：

Deyang

单位(医院)：

德阳市人民医院

具体地址：

中国四川省德阳市旌阳区泰山北路173号

Institution
hospital：

People's Hospital of Deyang city

Address：

173 Taishan North Road, Jingyang District, Deyang , Sichuan , China

经费或物资来源：

自筹

Source(s) of funding：

Self-collected

Target disease：

Sudden deafness accompanied by tinnitus

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：

随机平行对照 

Study design：

Parallel 

研究目的：

1.主要目的：探究突发性耳聋伴耳鸣患者心理情绪变化特征及经认知行为治疗后患者的生活质量变化及其对心理健康的影响；探究认知行为疗法对突聋伴耳鸣患者病情恢复、生活质量、心理健康是否有改善作用； 2.次要目的：针对突聋伴耳鸣患者，提出有针对性、易实施的治疗方案，从而改善患者生活质量及心理健康，促进家庭和谐，减少医疗负担。  

Objectives of Study：

1. Main objective: To explore the characteristics of psychological and emotional changes in patients with sudden deafness accompanied by tinnitus, as well as the changes in their quality of life after cognitive behavioral therapy and its impact on mental health; To explore whether cognitive behavioral therapy has an improving effect on the recovery, quality of life and mental health of patients with sudden deafness accompanied by tinnitus; 2. A secondary purpose: for patients with sudden deafness with tinnitus, put forward the treatment of targeted, easy to implement, improve patient's quality of life and mental health, promote family harmony, reduce the medical burden.

药物成份或治疗方案详述：

该研究为随机对照实验，随机化分组方法为随机数字表法，盲法设计为单盲设计。该实验分为甲乙两组，甲组为实验组即标准治疗＋认知行为疗法组，乙组为对照组即标准治疗组。 所有通过纳入标准的突发性耳聋伴耳鸣的在院患者均统一按2015版突聋指南推荐的金纳多87.5mg静滴1次/天、巴曲酶(首日1ml，后隔天1次0.5ml即第三、五、七、九天0.5ml）静滴、强的松（40mg3天+30mg3天+20mg3天+10mg1天）口服1次/天等药物治疗+高压氧1次/天+中医针灸1次/天等治疗一疗程即住院10天，耳鸣消失者则退出研究，耳鸣持续存在者将被选为研究对象。 通过随机数字表随机分为甲乙两组即实验组和对照组。在取得患者知情同意后，采用问卷形式收集每位研究对象的流行病学资料，并进行耳鸣程度评估、耳鸣疼痛程度评估、焦虑程度评估和睡眠质量评估及进行听力测试。 甲组在出院时由专业心理治疗师带领进行第一次CBT治疗，然后间隔2周进行下一次CBT访谈治疗，第四次访谈及以后可酌情因病人情况变为电话会谈，总共治疗6次，需时3个月，若耳鸣痊愈可提前结束疗程。完成历时3个月CBT治疗后需再次进行耳鸣程度评估、耳鸣疼痛程度评估、焦虑程度评估和睡眠质量评估及进行听力测试。 而乙组只需在出院时完成耳鸣程度评估、耳鸣疼痛程度评估、焦虑程度评估和睡眠质量评估及进行听力测试，3个月后再次回医院进行上述评估及听力测试即可。通过对比各量表即出院时及治疗末（出院3个月时）的分数变化来综合评估CBT疗法对耳鸣的疗效及分析该病患者的生活质量是否得到提高。 

Description for medicine or protocol of treatment in detail：

This study was a randomized controlled experiment. The randomization grouping method was the random number table method, and the blinding design was a single-blind design. This experiment was divided into two groups, Group A and Group B. Group A was the experimental group, namely the standard treatment + cognitive behavioral therapy group, and Group B was the control group, namely the standard treatment group. All inpatients with sudden deafness accompanied by tinnitus who passed the inclusion criteria were uniformly treated with intravenous infusion of Kinadol 87.5mg once a day and batroxobin (1ml on the first day) as recommended in the 2015 version of the sudden deafness guidelines. After that, 0.5ml was administered intravenously every other day, that is, 0.5ml on the third, fifth, seventh and ninth days. Prednisone (40mg for 3 days +30mg for 3 days +20mg for 3 days +10mg for 1 day) was taken orally once a day. One course of treatment included hyperbaric oxygen once a day and traditional Chinese acupuncture once a day. The patient was hospitalized for 10 days. Those whose tinnitus disappeared were withdrawn from the study. Those with persistent tinnitus will be selected as research subjects. They were randomly divided into Group A and Group B, namely the experimental group and the control group, through a random number table. After obtaining the informed consent of the patients, epidemiological data of each research subject were collected in the form of questionnaires, and tinnitus degree assessment, tinnitus pain degree assessment, anxiety degree assessment, sleep quality assessment and hearing test were conducted. Group A was led by a professional psychotherapist for the first CBT treatment upon discharge. Then, the next CBT interview treatment was conducted two weeks later. The fourth interview and subsequent sessions could be changed to telephone talks as appropriate based on the patient's condition. A total of six treatments were carried out, which took three months. If tinnitus was cured, the treatment could be ended earlier. After completing a 3-month CBT treatment, it is necessary to reassess the degree of tinnitus, the degree of tinnitus pain, the degree of anxiety, sleep quality and conduct a hearing test. Group B only needs to complete the assessment of tinnitus degree, tinnitus pain degree, anxiety degree and sleep quality at discharge and undergo a hearing test. Three months later, they can return to the hospital for the above assessment and hearing test again. By comparing each quantity. 

纳入标准：

1.18-75岁且能配合完成所有测试项目者；2.符合突发性耳聋伴耳鸣的诊断标准者参考《突发性聋诊断和治疗指南2015》；3.资料完整；4.入组时认功能正常者（简明精神量表（MMSE）得分文盲组＞17分、小学组＞20分、中学或以上组＞24分）；5.患者及家属自愿签订知情同意书；6.能接受本研究，并能长期坚持的患者。

Inclusion criteria

1.Those aged 18 to 75 who can cooperate to complete all test items; 2.Those who meet the diagnostic criteria for sudden deafness accompanied by tinnitus should refer to the "Guidelines for the Diagnosis and Treatment of Sudden Deafness 2015"; 3. Complete data; 4. Those with normal cognitive function at the time of enrollment (Brief Mental State Examination (MMSE) score > 17 points for the illiterate group, > 20 points for the primary school group, and > 24 points for the secondary school or above group); 5.Patients and their families voluntarily sign the informed consent form; 6. Patients who can accept this study and persist in it for a long time.

排除标准：

1.外伤及其他全身性疾病引起的听力下降或耳鸣者；2.耳道堵塞或引起外耳道堵塞的疾病、耳部生理解剖异常、内耳占位病变、听神经瘤等；3.医学上不稳定的（如癌症、中风、心血管疾病、慢性阻塞性肺疾病和严重精神病）疾病；4.精神障碍或认知障碍者，耳鸣发生前诊断为焦虑抑郁等及使用相关药物者；5.最近有严重头晕发作史者；6.一般资料不完整或中途退出本研究者；7.参加任何其他心理干预试验者。

Exclusion criteria：

1.Those with hearing loss or tinnitus caused by trauma or other systemic diseases; 2.Ear canal obstruction or diseases causing external auditory canal obstruction, physiological and anatomical abnormalities of the ear, space-occupying lesions in the inner ear, acoustic neuroma, etc; 3. Medically unstable diseases (such as cancer, stroke, cardiovascular disease, chronic obstructive pulmonary disease and severe mental illness); 4.People with mental disorders or cognitive impairments, those diagnosed with anxiety, depression, etc. before tinnitus occurs, and those using related medications; 5.Those who have recently experienced severe dizziness attacks; 6. Incomplete general information or withdrawal from this researcher halfway; 7. Participants in any other psychological intervention trials.

研究实施时间：

Study execute time：

从 From 2025-11-24 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-11-25 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

标准治疗＋认知行为疗法组

样本量：

60

Group：

Standard Treatment plus Cognitive Behavioral Therapy Group

Sample size：

干预措施：

标准治疗方案包括：金纳多87.5mg静滴1次/天、巴曲酶（首日1ml，之后于第3、5、7、9天各0.5ml）静滴、强的松口服（40mg×3天→30mg×3天→20mg×3天→10mg×1天），联合高压氧1次/天及中医针灸1次/天，疗程为住院10天；出院时由专业心理治疗师启动首次认知行为疗法（CBT），后续每2周进行一次面对面访谈，共6次，第四次起可根据情况转为电话会谈，总治疗周期为3个月，若耳鸣痊愈可提前终止疗程。

干预措施代码：

Intervention：

The standard treatment regimen includes: intravenous infusion of Jinnado 87.5 mg once daily, Batroxobin (1 mL on day 1, followed by 0.5 mL on days 3, 5, 7, and 9), and oral prednisone (40 mg for 3 days → 30 mg for 3 days → 20 mg for 3 days → 10 mg for 1 day), combined with hyperbaric oxygen therapy once daily and traditional Chinese acupuncture once daily, over a 10-day hospitalization course. Upon discharge, the patient receives the first session of cognitive behavioral therapy (CBT) led by a professional therapist, followed by biweekly in-person sessions for a total of six sessions; starting from the fourth session, follow-ups may be conducted by phone based on the patient’s condition. The total treatment duration is three months, but may be terminated early if tinnitus resolves completely.

Intervention code：

组别：

标准治疗组

样本量：

60

Group：

Standard Treatment Group

Sample size：

干预措施：

金纳多87.5mg静滴1次/天、巴曲酶(首日1ml，后隔天1次0.5ml即第三、五、七、九天0.5ml）静滴、强的松（40mg3天+30mg3天+20mg3天+10mg1天）口服1次/天等药物治疗+高压氧1次/天+中医针灸1次/天等治疗一疗程即住院10天

干预措施代码：

Intervention：

Jinnado 87.5 mg IV once daily, Batroxobin 1 mL IV on day 1 followed by 0.5 mL every other day (on days 3, 5, 7, and 9), oral prednisone (40 mg for 3 days → 30 mg for 3 days → 20 mg for 3 days → 10 mg for 1 day), plus hyperbaric oxygen therapy once daily and traditional Chinese acupuncture once daily, for a 10-day hospitalization course.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 德阳 

Country：

China 

Province：

Sichuan  

City：

Deyang 

单位(医院)：

德阳市人民医院 

单位级别：

三甲 

Institution
hospital：

People's Hospital of Deyang city

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

简易精神状态检查量表

指标类型：

主要指标

Outcome：

Mini-Mental State Examination (MMSE)

Type：

Primary indicator

测量时间点：

试验开始时（出院时）

测量方法：

量表填写

Measure time point of outcome：

At the beginning of the trial (at discharge)

Measure method：

Scale filling

指标中文名：

耳鸣残疾评估量表

指标类型：

主要指标

Outcome：

Tinnitus Disability Scale (TDS)

Type：

Primary indicator

测量时间点：

试验开始时（出院时）及治疗末（出院3个月时）

测量方法：

量表填写

Measure time point of outcome：

At the beginning of the trial (at discharge) and at the end of treatment (3 months after discharge)

Measure method：

Scale filling

指标中文名：

视觉模拟评分表

指标类型：

主要指标

Outcome：

Visual Analog Scale (VAS)

Type：

Primary indicator

测量时间点：

试验开始时（出院时）及治疗末（出院3个月时）

测量方法：

量表填写

Measure time point of outcome：

At the beginning of the trial (at discharge) and at the end of treatment (3 months after discharge)

Measure method：

Scale filling

指标中文名：

焦虑自评量表

指标类型：

主要指标

Outcome：

Self-Rating Anxiety Scale (SAS)

Type：

Primary indicator

测量时间点：

试验开始时（出院时）及治疗末（出院3个月时）

测量方法：

量表填写

Measure time point of outcome：

At the beginning of the trial (at discharge) and at the end of treatment (3 months after discharge)

Measure method：

Scale filling

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：

试验开始时（出院时）及治疗末（出院3个月时）

测量方法：

量表填写

Measure time point of outcome：

At the beginning of the trial (at discharge) and at the end of treatment (3 months after discharge)

Measure method：

Scale filling

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

Nothing

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

Nothing

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

由研究者用随机数字表法即将120个样本进行统一编号，在随机数表中，随机选择一个起始位置（例如，闭眼随机指认一个位置），并预先确定一个固定的读数方向，如从左到右、从上到下，或从右到左等?。从选定的起始位置开始，按照预先确定的方向，每次读取3位数字。将读取的数字与总体编号（000至119）进行比对：?若数字在编号范围内且未被选中?，则记录该数字对应的样本，并根据其奇偶性或顺序分配到实验组或对照组。例如，前60个有效编号为实验组，后60个为对照组。?若数字超出范围（如000或120及以上）或已重复?，则跳过该数字，继续读取下一个3位数?。根据上述步骤记录下的120个有效编号，将前60个编号对应的样本作为实验组，后60个编号对应的样本作为对照组。确保每个样本只被分配到一个组别?。

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

The researchers uniformly numbered 120 samples and randomly selected a starting position from a random number table (for example, randomly pointing to a position with eyes closed), and pre-determined a fixed reading direction, such as from left to right, from top to bottom, or from right to left, etc. Youdaoplaceholder0. Starting from the selected starting position, read three digits each time in the pre-determined direction. Compare the read number with the population number (000 to 119) : ? if the number is within the number range and is not selected ?, record the sample corresponding to that number and assign it to the experimental group or the control group according to its parity or order. For example, the first 60 valid numbers are the experimental group, and the last 60 are the control group. Youdaoplaceholder0 If the number is out of range (such as 000 or 120 and above) or has repeated ?, skip that number and proceed to read the next three-digit number ?. Based on the 120 valid numbers recorded in the above steps, the samples corresponding to the first 60 numbers were taken as the experimental group, and the samples corresponding to the last 60 numbers were taken as the control group. Make sure that each sample is assigned to only one group ?.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

单盲，即研究者根据试验需求将研究对象随机分配至实验组或对照组，但不向研究对象透露分组结果，研究对象对自身所属组别完全不知情。

Blinding：

Single-blind, that is, the researcher randomly assigns the research subjects to the experimental group or the control group according to the experimental requirements, but does not disclose the grouping results to the research subjects. The research subjects have no knowledge of their own group at all.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

研究结束半年；Resman平台

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

Six months after study completion; Resman 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：通过详细的病史问卷收集患者耳鸣的特征（如响度、音调、持续时间）、对生活的影响程度、伴随的神经心理症状（如焦虑、睡眠）等信息。并进行规范的听力检查（如纯音测听）和耳鸣检查，以客观评估听力损失和耳鸣情况。检查需遵循标准操作，确保数据的可靠性和可比性。在出院时（研究开始时）及治疗末（出院3个月时）分别进行耳鸣程度评估、耳鸣疼痛程度评估、焦虑程度评估和睡眠质量评估及进行听力测试，通过对比治疗前后各量表的分数变化来综合评估CBT疗法对耳鸣的疗效及分析该病患者的生活质量是否得到提高，以评估疗效的持续性和转归。 数据管理：1. 标准化与一致性：在同一机构内，耳鸣检查的方法应力求一致，以保证数据的可用性与可比性。 2. 动态更新：根据实际应用中发现的问题，及时对数据采集的各个环节（如问卷设计、接诊流程）进行必要的修改和完善。 3. 连续性与核实：随访资料应保持与初诊问卷内容的连贯性，对于有疑问的随访数据，应通过直接接触进行核实与修正。

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

Data collection: Through detailed medical history questionnaires, information on the characteristics of tinnitus in patients (such as loudness, pitch, duration), the degree of impact on life, and accompanying neuropsychological symptoms (such as anxiety, sleep) was collected. And conduct standardized hearing tests (such as pure tone audiometry) and tinnitus tests to objectively assess the condition of hearing loss and tinnitus. Inspections must follow standard operations to ensure the reliability and comparability of the data. Tinnitus degree assessment, tinnitus pain degree assessment, anxiety degree assessment, sleep quality assessment and hearing test were conducted respectively at discharge (at the beginning of the study) and at the end of treatment (3 months after discharge). By comparing the score changes of each scale before and after treatment, the efficacy of CBT therapy on tinnitus was comprehensively evaluated and whether the quality of life of patients with this disease was improved To evaluate the sustainability and outcome of the therapeutic effect. Data management: 1. Standardization and consistency: Within the same institution, the methods for tinnitus examination should be as consistent as possible to ensure the availability and comparability of the data. 2. Dynamic update: Based on the problems identified in practical applications, timely make necessary modifications and improvements to each link of data collection (such as questionnaire design and consultation process). 3. Continuity and verification: Follow-up data should maintain consistency with the content of the initial questionnaire. For questionable follow-up data, verification and correction should be carried out through direct contact.

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：

  2026-01-16 14:12:59