Randomized Trial Of Tinnitus Retraining Therapy

Tinnitus Clinical Trial

Official title:

Randomized Trial Of Tinnitus Retraining Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578058
• Other study ID #: R01DC005972
• Secondary ID: R01DC005972
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2007
• Last updated: August 2, 2011
• Start date: January 2004
• Est. completion date: November 2009

Study information

• Verified date: August 2011
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Other:
• Counseling and Sound Therapy
Tinnitus counseling and sound therapy

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University at Buffalo, State University of New York	Buffalo	New York
United States	University of Iowa	Iowa City	Iowa
United States	East Tennessee State University	Johnson City	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iowa Tinnitus Handicap Questionnaire		18 months	No
Secondary	Tinnitus measures		18 months	No