Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

December 8, 2018 updated by: Shu-sheng Gong, Beijing Friendship Hospital
This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The patients with tinnitus will be collected with medical history, ear examination ,auditory function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected as the research object.This study will be developed in the form of a blind randomized clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50 cases in each group. Psychological acoustic test, Resting-state function magnetic resonance imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively, followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the treatment will be compared. For those cases with poor results, the exchanged treatment will be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI, and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases will be followed up for 1 year, and questionnaire survey will be conducted again.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100031
        • Recruiting
        • Beijing Friendship Hospital,Capital Medical University
        • Contact:
          • Shu-Sheng Gong, MD
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages between 18-75 years
  • Tinnitus undergone for more than 6 months
  • Continuous attack, single tone dominated, annoying tinnitus
  • Able to cooperate with auditory function test and psychoacoustic test
  • The main tinnitus frequency is from 125Hz to 8000Hz
  • Willing to use the equipment daily during the test
  • Willing and able to follow up regularly
  • Ability to read and write Chinese, able to understand and complete questionnaires

Exclusion Criteria:

  • Secondary tinnitus
  • Pure tone audiometry shows conduction deafness or mixed deafness
  • Tinnitus main frequency threshold >60dB
  • Receiving treatment for other tinnitus
  • MRI contraindications
  • Feeling uncomfortable with the treatment equipment or not being accepted

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
Experimental: CAABT
CAABT(Cochleural Alternating Acoustic Beam Therapy) is an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.
Device: CAABT
The sound generators with CAABT will be used 15 min each session, three times a day
Active Comparator: TMT
TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.
Device: TMT
The sound generators with TMT will be used 15 min each session, three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory ( THI)
Time Frame: baseline, 2 months, 4 months, 6 months

Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale.

Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased < 17 points or even increased.Efficiency is the sum of cure and effect.
baseline, 2 months, 4 months, 6 months
Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
Time Frame: baseline, 6 months
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
baseline, 6 months
Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
Time Frame: baseline, 6 months
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
baseline, 6 months
Visual Analogue Scale(VAS)
Time Frame: baseline, 2 months, 4 months, 6 months

Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS).

The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe
baseline, 2 months, 4 months, 6 months

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Director: Shu-Sheng Gong, MD, Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2018

Primary Completion (Anticipated)

June 8, 2019

Study Completion (Anticipated)

December 8, 2019

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 8, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-P2-182-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be made available within 6 months of study completion

IPD Sharing Time Frame

Data access requests will be reviewed by an external Independent Review Panel.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Independent Review Panel

IPD Sharing Supporting Information Type

  • Study Protocol

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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