Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

Not Applicable

• Conditions: Tinnitus, Subjective
• Interventions: Other: music therapy

• Registration Number: NCT04449237
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-26
• Status Verified: 2020-07
• Study Start: 2020-07-01
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with modified tinnitus relieving music	music therapy	40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch
patients with unmodified music group	music therapy	40 participants in this group will listen to music without any modification
volunteer	music therapy	40 volunteer will not accept any treatment

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Distress Scale	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	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	From date of randomization, assessed every 3 month, up to 24 month	estimated by auditory facility, recorded by unit of dB
electroencephalogram evaluation	From date of randomization, assessed every 3 month, up to 24 month	amplitude
the frequency of tinnitus	From date of randomization, assessed every 3 month, up to 24 month	estimated by auditory facility, recorded by unit of Hz
minimum masking level	From date of randomization, assessed every 3 month, up to 24 month	the minimum volume to masking tinnitus, recorded by unit of dB