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Evaluation of Treatment Methods for Clinically Significant Tinnitus

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ClinicalTrials.gov Identifier: NCT00013390
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
VA Office of Research and Development

Brief Summary:
The investigators propose to evaluate two different approaches to the alleviation of tinnitus symptoms by comparing changes from baseline performance on the Tinnitus Severity Index. They propose to provide an unbiased evaluation of competing methodologies. The design is one in which pairs of prospective subjects are randomly assigned to one of two treatment groups. Changes in group performance will be compared for selected measures.

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Active Comparator: 1
Tinnitus Masking
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).

2
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




Primary Outcome Measures :
  1. 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.



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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:

Patients with significant tinnitus

Exclusion Criteria:


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): NCT00013390


Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: James Henry, PhD VA Medical Center, Portland

Responsible Party: Henry, James - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013390     History of Changes
Other Study ID Numbers: C1995R
First Posted: March 16, 2001    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011

Keywords provided by VA Office of Research and Development:
Auditory, tinnitus

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