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Randomized Trial Of Tinnitus Retraining Therapy

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ClinicalTrials.gov Identifier: NCT00578058
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : August 3, 2011
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
University of Iowa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tinnitus Other: Counseling and Sound Therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Trial Of Tinnitus Retraining Therapy
Study Start Date : January 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Iowa Tinnitus Handicap Questionnaire [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Tinnitus measures [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578058


Locations
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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
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Richard S Tyler, Ph.D. University of Iowa
More Information
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Responsible Party: Richard S. Tyler, Ph.D., University of Iowa
ClinicalTrials.gov Identifier: NCT00578058    
Other Study ID Numbers: R01DC005972 ( U.S. NIH Grant/Contract )
R01DC005972 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases