Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

NCT ID: NCT04449237

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-06-30

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.

Conditions

Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

volunteer

40 volunteer will not accept any treatment

Group Type: OTHER

music therapy

Intervention Type: OTHER

music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.

patients with unmodified music group

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

Group Type: PLACEBO_COMPARATOR

music therapy

Intervention Type: OTHER

music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.

patients with modified tinnitus relieving music

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

Group Type: EXPERIMENTAL

music therapy

Intervention Type: OTHER

music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.

Interventions

music therapy

music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

sunshan

Identifier Type: -

Identifier Source: org_study_id