Randomized Trial Of Tinnitus Retraining Therapy

University of Iowa

Status and phase: Completed; Phase 2

Conditions: Tinnitus

Treatments: Other: Counseling and Sound Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00578058

R01DC005972 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

180 participants in 6 patient groups

1

Other group

Description:

Counseling plus everyday noise type 1

Treatment:

Other: Counseling and Sound Therapy

2

Other group

Description:

Counseling plus static noise type 2

Treatment:

Other: Counseling and Sound Therapy

3

Other group

Description:

Counseling plus static noise type 3

Treatment:

Other: Counseling and Sound Therapy

4

Other group

Description:

Hearing aid and counseling plus everyday noise type 1

Treatment:

Other: Counseling and Sound Therapy

5

Other group

Description:

Hearing aid and counseling plus static noise type 2

Treatment:

Other: Counseling and Sound Therapy

6

Other group

Description:

Hearing aid and counseling plus static noise type 3

Treatment:

Other: Counseling and Sound Therapy