Clinical trial NCT04449237: Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
Official title: The Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 18-30 years old, male or female;
2. PTA (0.5,1,2kHz) ≤25dB HL;
3. Tinnitus is a major problem faced by patients (except healthy volunteers);
4. tinnitus course \> for 3 months;
5. Healthy, no history of other ear diseases, no history of hearing impairment;
6. There are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment;
7. Voluntary tinnitus treatment, and have enough time to cooperate with treatment.

Exclusion Criteria:

1. Pulsatile tinnitus;
2. Acute tinnitus;
3. Tinnitus is associated with severe hearing loss;
4. Tinnitus accompanied by vertigo;
5. Tinnitus accompanied by headache;
6. Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder;
7. Post-traumatic tinnitus;
8. Tinnitus is associated with serious psychiatric complications;

Primary outcomes:
measure: electroencephalogram evaluation
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
measure: electroencephalogram evaluation
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
measure: electroencephalogram evaluation
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
measure: the loudness of tinnitus
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
measure: the frequency of tinnitus
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
measure: minimum masking level
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
measure: Tinnitus Handicapped Inventory
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
measure: Hospital Anxiety and Distress Scale
timeFrame: From date of randomization, assessed every 3 month, up to 24 month
Secondary outcomes:
Other outcomes:
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