Evaluation of Auditory Mirror-therapy for Tinnitus

Study Overview
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Brief Summary
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The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. This procedure is called Auditory Mirror Therapy (AMT).

Detailed Description
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The goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (AMT) for chronic tinnitus. Hypothesis: AMT, as contrasted to a sham device, will significantly reduce symptom ratings on the Tinnitus Functional Index (TFI) scale. Along with TFI, additional measures will be collected every two days throughout the intervention; Tinnitus Handicap Index, Visual Analogue Scale, Minimum Masking Level (MML) and Residual Inhibition (RI), and Auditory Mirror Therapy Questionnaire.

Official Title
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Evaluation of Auditory Mirror-therapy for Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Auditory Mirror Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Ages 18-80 years old Chronic Tinnitus (> 3months) Exclusion Criteria: Use of hearing aids No history of significant drug or alcohol use No history of debilitating neurological or psychiatric illnesses No current or past history of balance-, vertigo- and/or vestibular- symptoms including Ménières disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auditory Mirror Therapy Device<br>Modified 3M Peltor Tactical 300 Electronic Hearing Protector. The modification consists of connecting the left microphone to the right microphone tab on the circuit board, and vice versa. | Device: Auditory Mirror Therapy<br>* 21 days, up to 3 hours per day intervention<br>|
| Sham Comparator: Sham Headphone Device<br>Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector | Device: Auditory Mirror Therapy<br>* 21 days, up to 3 hours per day intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Functional Index (TFI) | 25 question inventory that developed to provide a scaling of tinnitus severity, an identification of tinnitus domains with impact on the tinnitus severity, and a responsive measurement of change in tinnitus severity. The TFI will be used to determine the efficacy of a 21 day, 3 hours per day, intervention of auditory mirror-therapy (AMT) for chronic tinnitus | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Handicap Inventory (THI) | a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living. | 3 weeks | 
| Change in Visual Analogue Scale (VAS) | Scale from 0 to 100 for tinnitus awareness, loudness and annoyance, on separate VAS. VAS loudness and annoyance are valid and effective measurements for capturing reductions in tinnitus severity in patients with chronic tinnitus | 3 weeks | 
| Change in Minimum Masking Level (MML) and residual inhibition (RI) | MML is defined as the lowest tone intensity level required to cover or mask and individual's tinnitus. Correspondingly, the RI is considered the temporary decrease of tinnitus after a prolonged acoustic stimulation. | 3 weeks |