The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

Tinnitus Research Consortium

Status and phase: Completed; Phase 1

Conditions: Tinnitus

Treatments: Device: Sound therapy; Behavioral: Tinnitus retraining therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00124800

05-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind