Tinnitus
Conditions
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).
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.
Interventions
DEVICEAuditory Mirror Therapy
21 days, up to 3 hours per day intervention
Sponsors
Spaulding Rehabilitation Hospital
Harvard University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Concealment of treatment allocation is not possible
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Functional Index (TFI) | 3 weeks | The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress. The change in TFI score between baseline and follow up is reported, with negative numbers indicating a decrease in tinnitus severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 17 Participants |
| Tinnitus functional index | 40.8 units on a scale STANDARD_DEVIATION 19.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 23 |
| other Total, other adverse events | 0 / 33 | 0 / 23 |
| serious Total, serious adverse events | 0 / 33 | 0 / 23 |
Outcome results
None listed