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

Phase 1

Completed

• Conditions: Tinnitus

• Registration Number: NCT00124800
• Lead Sponsor: Tinnitus Research Consortium

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.

Study Timeline

• Study First Submitted: 2005-07-27
• Study First Submitted QC: 2005-07-27
• Study First Posted: 2005-07-28
• Study Start: 2005-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in subjective ratings of tinnitus loudness, annoyance and awareness	18 months

Trial Locations

Locations (1)

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States