Evaluation of Auditory Mirror-therapy for Tinnitus
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Auditory Mirror Therapy Device 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
21 days, up to 3 hours per day intervention
|
| Sham Comparator: Sham Headphone Device Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector |
Device: Auditory Mirror Therapy
21 days, up to 3 hours per day intervention
|
Outcome Measures
Primary Outcome Measures
- Change in Tinnitus Functional Index (TFI) [3 weeks]
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
Secondary Outcome Measures
- Change in Tinnitus Handicap Inventory (THI) [3 weeks]
a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.
- Change in Visual Analogue Scale (VAS) [3 weeks]
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
- Change in Minimum Masking Level (MML) and residual inhibition (RI) [3 weeks]
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.
Other Outcome Measures
- Auditory Mirror Therapy Questionnaire [3 weeks]
developed to qualitatively analyze how AMT is affecting participants' tinnitus throughout the intervention study. here
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female
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Ages 18-80 years old
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Chronic Tinnitus (> 3months)
Exclusion Criteria:
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Use of hearing aids
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No history of significant drug or alcohol use
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No history of debilitating neurological or psychiatric illnesses
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No current or past history of balance-, vertigo- and/or vestibular- symptoms including Ménières disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spaulding Rehabilitation Hospital | Charlestown | Massachusetts | United States | 02129 |
Sponsors and Collaborators
- Spaulding Rehabilitation Hospital
- Harvard University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016P000820