Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

Last updated: December 8, 2018
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tinnitus

Treatment

N/A

Clinical Study ID

NCT03764826
2018-P2-182-01
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 100
Study Start date:
December 01, 2018
Estimated Completion Date:
December 08, 2019

Study 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.

Connect with a study center

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, Beijing 100031
    China

    Active - Recruiting

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