Cochleural Alternating Acoustic Beam Therapy (CAABT) Versus Masking Intervention for Tinnitus

Study Overview
=================
Brief Summary
-----------------
This study is to compare the effectiveness of CAABT and masking therapy in the management of subjective tinnitus in adults.Half of participants will receive CAABT, while the other half will receive masking therapy.

Detailed Description
-----------------
Masking intervention was a standard monophone tinnitus masking therapy. It was usually a narrow-band noise matched with tinnitus frequency (Tf). CAABT was 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.

Official Title
-----------------
Cochleural Alternating Acoustic Beam Therapy Versus Masking Intervention for Tinnitus: A Randomised Controlled Trial

Conditions
-----------------
Tinnitus, Subjective

Intervention / Treatment
-----------------
* Device: CAABT
* Device: masking therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral tinnitus Ages between 18-80 years Tinnitus undergone for more than 6 months Hearing loss of the tinnitus ear not affect communication The main tinnitus frequency is less than 8 KHz Primary tinnitus Exclusion Criteria: Secondary tinnitus Hyperacusis Patients were accepting any therapy about tinnitus Those who have serious mental illness Patients who can't fit the audiological examination and tinnitus tests Most of the hearing loss in the middle and severe hearing loss of the tinnitus ear Any MRI contraindications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: masking therapy<br>Masking intervention was a standard monophone tinnitus masking therapy. | Device: masking therapy<br>* Masking intervention was a standard monophone tinnitus masking therapy.<br>|
| Experimental: CAABT<br>CAABT was 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>* CAABT was 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry |  | baseline and 12 weeks | 
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness |  | baseline and 12 weeks | 
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level |  | baseline and 12 weeks | 
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale |  | baseline and 12 weeks | 
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale |  | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI) |  | baseline and 12 weeks |