The Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Hospital Anxiety and Distress Scale
研究概览
简要总结
This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.
详细描述
Tinnitus is one of the most common auditory disturbances in human. The treatment of tinnitus is always not effective, and the standardized treatment of tinnitus has been lacking. With the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the central mechanism of tinnitus has been gradually revealed. The possible mechanisms of tinnitus are the increase of spontaneous discharge rate and synchronization of auditory central neurons caused by hearing deprivation, the change of brain topological structure, the reorganization of auditory cortex, and the disorder of limbic system and auditory central regulation of tinnitus patients. EEG, as an important means to study the cerebral cortex, has become an important technical support for the research on the central mechanism of tinnitus. Changes in activity in auditory brain areas associated with tinnitus have been observed using EEG/ERPs, and non-auditory brain areas such as the limbic system and frontal cortices have also been associated with tinnitus mechanisms. This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-30 years old, male or female;
- •PTA (0.5,1,2kHz) ≤25dB HL;
- •Tinnitus is a major problem faced by patients (except healthy volunteers);
- •tinnitus course > for 3 months;
- •Healthy, no history of other ear diseases, no history of hearing impairment;
- •There are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment;
- •Voluntary tinnitus treatment, and have enough time to cooperate with treatment.
排除标准
- •Pulsatile tinnitus;
- •Acute tinnitus;
- •Tinnitus is associated with severe hearing loss;
- •Tinnitus accompanied by vertigo;
- •Tinnitus accompanied by headache;
- •Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder;
- •Post-traumatic tinnitus;
- •Tinnitus is associated with serious psychiatric complications;
结局指标
主要结局
Hospital Anxiety and Distress Scale
时间窗: From date of randomization, assessed every 3 month, up to 24 month
0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.
Tinnitus Handicapped Inventory
时间窗: From date of randomization, assessed every 3 month, up to 24 month
Tinnitus disability is divided into four levels, the first level: 0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.
the loudness of tinnitus
时间窗: From date of randomization, assessed every 3 month, up to 24 month
estimated by auditory facility, recorded by unit of dB
the frequency of tinnitus
时间窗: From date of randomization, assessed every 3 month, up to 24 month
estimated by auditory facility, recorded by unit of Hz
minimum masking level
时间窗: From date of randomization, assessed every 3 month, up to 24 month
the minimum volume to masking tinnitus, recorded by unit of dB
electroencephalogram evaluation
时间窗: From date of randomization, assessed every 3 month, up to 24 month
latency
次要结局
未报告次要终点