Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention (EEG-RCT)

Eye & ENT Hospital of Fudan University

Status: Unknown

Conditions: Tinnitus, Subjective

Treatments: Other: music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04449237

sunshan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups, including a placebo group

volunteer

Other group

Description:

40 volunteer will not accept any treatment

Treatment:

Other: music therapy

patients with unmodified music group

Placebo Comparator group

Description:

40 participants in this group will listen to music without any modification

Treatment:

Other: music therapy

patients with modified tinnitus relieving music

Experimental group

Description:

40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch

Treatment:

Other: music therapy