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
  Purpose

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.


Condition Intervention Phase
Tinnitus
Other: Counseling and Sound Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Trial Of Tinnitus Retraining Therapy

Resource links provided by NLM:


Further study details as provided by University of Iowa:

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

Secondary Outcome Measures:
  • Tinnitus measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Counseling plus everyday noise type 1
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
2
Counseling plus static noise type 2
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
3
Counseling plus static noise type 3
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
4
Hearing aid and counseling plus everyday noise type 1
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
5
Hearing aid and counseling plus static noise type 2
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy
6
Hearing aid and counseling plus static noise type 3
Other: Counseling and Sound Therapy
Tinnitus counseling and sound therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578058

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
University at Buffalo, State University of New York
Buffalo, New York, United States, 14214
United States, Tennessee
East Tennessee State University
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Richard S Tyler, Ph.D. University of Iowa
  More Information

No publications provided

Responsible Party: Richard S. Tyler, Ph.D., University of Iowa
ClinicalTrials.gov Identifier: NCT00578058     History of Changes
Other Study ID Numbers: R01DC005972, R01DC005972
Study First Received: December 18, 2007
Last Updated: August 2, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014