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

July 2, 2020 updated by: Eye & ENT Hospital of Fudan University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: volunteer
40 volunteer will not accept any treatment
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.
Placebo Comparator: patients with unmodified music group
40 participants in this group will listen to music without any modification
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.
Experimental: patients with modified tinnitus relieving music
40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electroencephalogram evaluation
Time Frame: From date of randomization, assessed every 3 month, up to 24 month
latency
From date of randomization, assessed every 3 month, up to 24 month
electroencephalogram evaluation
Time Frame: From date of randomization, assessed every 3 month, up to 24 month
peak
From date of randomization, assessed every 3 month, up to 24 month
electroencephalogram evaluation
Time Frame: From date of randomization, assessed every 3 month, up to 24 month
amplitude
From date of randomization, assessed every 3 month, up to 24 month
the loudness of tinnitus
Time Frame: From date of randomization, assessed every 3 month, up to 24 month
estimated by auditory facility, recorded by unit of dB
From date of randomization, assessed every 3 month, up to 24 month
the frequency of tinnitus
Time Frame: From date of randomization, assessed every 3 month, up to 24 month
estimated by auditory facility, recorded by unit of Hz
From date of randomization, assessed every 3 month, up to 24 month
minimum masking level
Time Frame: From date of randomization, assessed every 3 month, up to 24 month
the minimum volume to masking tinnitus, recorded by unit of dB
From date of randomization, assessed every 3 month, up to 24 month
Tinnitus Handicapped Inventory
Time Frame: 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.
From date of randomization, assessed every 3 month, up to 24 month
Hospital Anxiety and Distress Scale
Time Frame: 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.
From date of randomization, assessed every 3 month, up to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sunshan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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