Evaluation of Treatment Methods for Clinically Significant Tinnitus

This study has been completed.

Sponsor:

Information provided by:

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00013390

First received: March 14, 2001

Last updated: May 17, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 14, 2001

Last Updated Date

May 17, 2011

Start Date ^ICMJE

October 1999

Primary Completion Date

September 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tinnitus Severity Index [ Time Frame: Baseline, 3 mo., 6 mo., 12 mo., 18 mo. ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00013390 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Treatment Methods for Clinically Significant Tinnitus

Official Title ^ICMJE

Evaluation of Treatment Methods for Clinically Significant Tinnitus

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Tinnitus

Intervention ^ICMJE

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).
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

Study Arm (s)

Active Comparator: 1
Tinnitus Masking

Intervention: Procedure: Tinnitus Masking
2
Tinnitus Retraining Therapy

Intervention: Procedure: Tinnitus Retraining Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

September 2002

Primary Completion Date

September 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with significant tinnitus

Exclusion Criteria:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00013390

Other Study ID Numbers ^ICMJE

C1995R

Has Data Monitoring Committee

Responsible Party

Henry, James - Principal Investigator, Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

James Henry, PhD

VA Medical Center, Portland

Information Provided By

Department of Veterans Affairs

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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