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Evaluation of Treatment Methods for Clinically Significant Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tinnitus Masking
Tinnitus Retraining Therapy
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Auditory, tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with significant tinnitus Exclusion Criteria:

Sites / Locations

  • VA Medical Center, Portland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

Tinnitus Masking

Tinnitus Retraining Therapy

Outcomes

Primary Outcome Measures

Tinnitus Severity Index
A well-developed scale currently in use at the Oregon Tinnitus Clinic.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2001
Last Updated
May 17, 2011
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00013390
Brief Title
Evaluation of Treatment Methods for Clinically Significant Tinnitus
Official Title
Evaluation of Treatment Methods for Clinically Significant Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
September 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Auditory, tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Tinnitus Masking
Arm Title
2
Arm Type
Other
Arm Description
Tinnitus Retraining Therapy
Intervention Type
Procedure
Intervention Name(s)
Tinnitus Masking
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Tinnitus Retraining Therapy
Other Intervention Name(s)
TRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Severity Index
Description
A well-developed scale currently in use at the Oregon Tinnitus Clinic.
Time Frame
Baseline, 3 mo., 6 mo., 12 mo., 18 mo.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with significant tinnitus Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Henry, PhD
Organizational Affiliation
VA Medical Center, Portland
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

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Evaluation of Treatment Methods for Clinically Significant Tinnitus

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