Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Other: music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: volunteer<br>40 volunteer will not accept any treatment | Other: music therapy<br>* music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.<br>|
| Placebo Comparator: patients with unmodified music group<br>40 participants in this group will listen to music without any modification | Other: music therapy<br>* music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.<br>|
| Experimental: patients with modified tinnitus relieving music<br>40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch | Other: music therapy<br>* music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electroencephalogram evaluation | latency | From date of randomization, assessed every 3 month, up to 24 month | 
| electroencephalogram evaluation | peak | From date of randomization, assessed every 3 month, up to 24 month | 
| electroencephalogram evaluation | amplitude | From date of randomization, assessed every 3 month, up to 24 month | 
| the loudness of tinnitus | estimated by auditory facility, recorded by unit of dB | From date of randomization, assessed every 3 month, up to 24 month | 
| the frequency of tinnitus | estimated by auditory facility, recorded by unit of Hz | From date of randomization, assessed every 3 month, up to 24 month | 
| minimum masking level | the minimum volume to masking tinnitus, recorded by unit of dB | From date of randomization, assessed every 3 month, up to 24 month | 
| Tinnitus Handicapped Inventory | 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. | From date of randomization, assessed every 3 month, up to 24 month | 
| Hospital Anxiety and Distress Scale | 0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist. | From date of randomization, assessed every 3 month, up to 24 month |