Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

Tinnitus, Subjective Clinical Trial

— EEG-RCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04449237
• Other study ID #: sunshan
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2020
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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;

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electroencephalogram evaluation	latency	From date of randomization, assessed every 3 month, up to 24 month
Primary	electroencephalogram evaluation	peak	From date of randomization, assessed every 3 month, up to 24 month
Primary	electroencephalogram evaluation	amplitude	From date of randomization, assessed every 3 month, up to 24 month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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