Randomized Trial Of Tinnitus Retraining Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00578058

Enrollment

180

Registered

2007-12-20

Start date

2004-01-31

Completion date

2009-11-30

Last updated

2011-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

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.

Interventions

OTHERCounseling and Sound Therapy

Tinnitus counseling and sound therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Iowa Tinnitus Handicap Questionnaire	18 months

Secondary

Measure	Time frame
Tinnitus measures	18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026