Tinnitus
Conditions
Keywords
tinnitus
Brief summary
The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.
Detailed description
The specific aims of the study are to: * Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus. * Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus. * Determine the therapeutic time course of improvement in tinnitus. * Determine the long-term improvement in tinnitus derived from TRT.
Interventions
BEHAVIORALTinnitus retraining therapy
Sound therapy and counseling
DEVICESound therapy
sound therapy and counselling
Sponsors
Tinnitus Research Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Chronic non-pulsatile tinnitus
Exclusion criteria
* Hyperacusis * Subjective hearing loss * Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL) * Evidence of significant depression or suicidal ideation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in objective measure of tinnitus loudness using psychoacoustic matching task | 18 months |
| Change in subjective handicap rating of tinnitus using a standardized questionnaire | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in subjective ratings of tinnitus loudness, annoyance and awareness | 18 months |
Countries
United States
Outcome results
None listed