Randomized Trial Of Tinnitus Retraining Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00578058
First received: December 18, 2007
Last updated: August 2, 2011
Last verified: August 2011

December 18, 2007
August 2, 2011
January 2004
November 2009   (final data collection date for primary outcome measure)
Iowa Tinnitus Handicap Questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00578058 on ClinicalTrials.gov Archive Site
Tinnitus measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Trial Of Tinnitus Retraining Therapy
Randomized Trial Of Tinnitus Retraining Therapy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Tinnitus
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
  • 1
    Counseling plus everyday noise type 1
    Intervention: Other: Counseling and Sound Therapy
  • 2
    Counseling plus static noise type 2
    Intervention: Other: Counseling and Sound Therapy
  • 3
    Counseling plus static noise type 3
    Intervention: Other: Counseling and Sound Therapy
  • 4
    Hearing aid and counseling plus everyday noise type 1
    Intervention: Other: Counseling and Sound Therapy
  • 5
    Hearing aid and counseling plus static noise type 2
    Intervention: Other: Counseling and Sound Therapy
  • 6
    Hearing aid and counseling plus static noise type 3
    Intervention: Other: Counseling and Sound Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00578058
R01DC005972, R01DC005972
Yes
Richard S. Tyler, Ph.D., University of Iowa
University of Iowa
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Richard S Tyler, Ph.D. University of Iowa
University of Iowa
August 2011

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