Randomized Trial Of Tinnitus Retraining Therapy

August 2, 2011 updated by: University of Iowa
Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will investigate the contributions of counseling, the use of hearing aids and sound generators, and the importance of setting masking noise to a particular level. All groups will receive the same Counseling. In pilot studies we have developed a picture-based counseling protocol. The results of this study will determine if TRT is more effective than masking or counseling alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

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
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo, State University of New York
    • Tennessee
      • Johnson City, Tennessee, United States, 37614
        • East Tennessee State University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have experienced tinnitus for at least 4 months.
  • Have the ability to participate in research.

Exclusion Criteria:

  • Have a treatable otological disorder.
  • Are involved in litigation.
  • Have or are suspected of having a serious psychiatric problem.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Counseling plus everyday noise type 1
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
Other: 2
Counseling plus static noise type 2
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
Other: 3
Counseling plus static noise type 3
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
Other: 4
Hearing aid and counseling plus everyday noise type 1
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
Other: 5
Hearing aid and counseling plus static noise type 2
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
Other: 6
Hearing aid and counseling plus static noise type 3
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Iowa Tinnitus Handicap Questionnaire
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tinnitus measures
Time Frame: 18 months
18 months

Collaborators and Investigators

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

Sponsor

University of Iowa

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Richard S Tyler, Ph.D., University of Iowa

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

January 1, 2004

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DC005972 (U.S. NIH Grant/Contract)

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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