Evaluation of Treatment Methods for Clinically Significant Tinnitus
|ClinicalTrials.gov Identifier: NCT00013390|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : May 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Procedure: Tinnitus Masking Procedure: Tinnitus Retraining Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Treatment Methods for Clinically Significant Tinnitus|
|Study Start Date :||October 1999|
|Actual Primary Completion Date :||September 2002|
|Actual Study Completion Date :||September 2002|
Active Comparator: 1
Procedure: Tinnitus Masking
Tinnitus Masking is a widely-used method for providing relief of tinnitus. The central premise of Tinnitus Masking involves the use of wearable ear-level devices (hearing aids, maskers, or combination instruments) that deliver sound to a patient's ear(s). The primary purpose of the sound presentation is to produce a sense of relief from the annoyance caused by the tinnitus sound. The relief is accomplished by either obscuring, or "covering up" (masking) the tinnitus sound, or by changing the sound of the tinnitus in some way, usually by reducing its loudness (Vernon, Meikle).
Tinnitus Retraining Therapy
Procedure: Tinnitus Retraining Therapy
Tinnitus Retraining Therapy (TRT) was derived from a purely psychological approach for facilitating tinnitus habituation (Hallam et al). The current method is based on neurophysiological principles, and aims at "retraining" brain regions that are involved in processing the tinnitus signal, without attempting to suppress generation of the signal (Jastreboff). The retraining involves a systematic effort aimed at decreasing both the detectability of tinnitus and the transmission of the tinnitus "signal" to emotional centers of the brain. Habituation of tinnitus thus purportedly occurs at two levels: habituation of emotional reactions to the tinnitus and habituation of tinnitus perception. Habituation is achieved by utilizing directive counseling, along with the use of low-level broadband noise to reduce the detectability of tinnitus for patients with normal or near-normal hearing. When hearing loss is a significant problem to the patient, appropriate hearing aids are fitted.
Other Name: TRT
- Tinnitus Severity Index [ Time Frame: Baseline, 3 mo., 6 mo., 12 mo., 18 mo. ]A well-developed scale currently in use at the Oregon Tinnitus Clinic.
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): NCT00013390
|United States, Oregon|
|VA Medical Center, Portland|
|Portland, Oregon, United States, 97201|
|Principal Investigator:||James Henry, PhD||VA Medical Center, Portland|