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

September 23, 2009 updated by: Tinnitus Research Consortium
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62794
        • Southern Illinois University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in objective measure of tinnitus loudness using psychoacoustic matching task
Time Frame: 18 months
18 months
Change in subjective handicap rating of tinnitus using a standardized questionnaire
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in subjective ratings of tinnitus loudness, annoyance and awareness
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tinnitus Research Consortium

Investigators

  • Principal Investigator: Carol A Bauer, MD, Southern Illinois University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 27, 2005

First Submitted That Met QC Criteria

July 27, 2005

First Posted (Estimate)

July 28, 2005

Study Record Updates

Last Update Posted (Estimate)

September 24, 2009

Last Update Submitted That Met QC Criteria

September 23, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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