Randomized Trial Of Tinnitus Retraining Therapy

Phase 2

Completed

• Conditions: Tinnitus
• Interventions: Other: Counseling and Sound Therapy

• Registration Number: NCT00578058
• Lead Sponsor: University of Iowa

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Counseling and Sound Therapy	Hearing aid and counseling plus everyday noise type 1
1	Counseling and Sound Therapy	Counseling plus everyday noise type 1
2	Counseling and Sound Therapy	Counseling plus static noise type 2
3	Counseling and Sound Therapy	Counseling plus static noise type 3
5	Counseling and Sound Therapy	Hearing aid and counseling plus static noise type 2
6	Counseling and Sound Therapy	Hearing aid and counseling plus static noise type 3

Primary Outcome Measures

Name	Time	Method
Iowa Tinnitus Handicap Questionnaire	18 months

Secondary Outcome Measures

Name	Time	Method
Tinnitus measures	18 months

Trial Locations

Locations (4)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

East Tennessee State University; 🇺🇸 Johnson City, Tennessee, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University at Buffalo, State University of New York; 🇺🇸 Buffalo, New York, United States