Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Device: CAABT
* Device: TMT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAABT<br>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<br>* The sound generators with CAABT will be used 15 min each session, three times a day<br>|
| Active Comparator: TMT<br>TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus. | Device: TMT<br>* The sound generators with TMT will be used 15 min each session, three times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory ( THI) | 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 | 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) | Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF | baseline, 6 months | 
| Visual Analogue Scale(VAS) | 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 |