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| Sponsor: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
|---|---|
| Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
| ClinicalTrials.gov Identifier: | NCT00578058 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
| Official Title: | Randomized Trial Of Tinnitus Retraining Therapy |
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | November 2009 |
| Estimated 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Richard S Tyler, Ph.D. | University of Iowa |
More Information
| Responsible Party: | University of Iowa ( Richard S. Tyler, Ph.D. ) |
| Study ID Numbers: | R01DC005972 |
| Study First Received: | December 18, 2007 |
| Last Updated: | December 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00578058 History of Changes |
| Health Authority: | United States: Federal Government |
|
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Nervous System Diseases Neurologic Manifestations Ear Diseases Tinnitus |
