Randomized Trial Of Tinnitus Retraining Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

December 11, 2008

Start Date ^ICMJE

January 2004

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Iowa Tinnitus Handicap Questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00578058 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tinnitus measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Randomized Trial Of Tinnitus Retraining Therapy

Official Title ^ICMJE

Randomized Trial Of Tinnitus Retraining Therapy

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Condition ^ICMJE

Tinnitus

Intervention ^ICMJE

Other: Counseling and Sound Therapy

Study Arms / Comparison Groups

Other: Counseling plus everyday noise type 1
Other: Counseling plus static noise type 2
Other: Counseling plus static noise type 3
Other: Hearing aid and counseling plus everyday noise type 1
Other: Hearing aid and counseling plus static noise type 2
Other: Hearing aid and counseling plus static noise type 3

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00578058

Responsible Party

Richard S. Tyler, Ph.D., University of Iowa

Study ID Numbers ^ICMJE

R01DC005972

Study Sponsor ^ICMJE

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Richard S Tyler, Ph.D.

University of Iowa

Information Provided By

National Institute on Deafness and Other Communication Disorders (NIDCD)

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP