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Clinical Trials/NCT00124800
NCT00124800
Completed
Phase 1

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

Tinnitus Research Consortium1 site in 1 country41 target enrollmentNovember 2005
ConditionsTinnitus

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Tinnitus
Sponsor
Tinnitus Research Consortium
Enrollment
41
Locations
1
Primary Endpoint
Change in objective measure of tinnitus loudness using psychoacoustic matching task
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
June 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tinnitus Research Consortium

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in objective measure of tinnitus loudness using psychoacoustic matching task

Time Frame: 18 months

Change in subjective handicap rating of tinnitus using a standardized questionnaire

Time Frame: 18 months

Secondary Outcomes

  • Change in subjective ratings of tinnitus loudness, annoyance and awareness(18 months)

Study Sites (1)

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