Evaluation of Treatment Methods for Clinically Significant Tinnitus - Full Text View

Purpose

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	Intervention	Phase
Tinnitus	Procedure: Tinnitus Masking Procedure: Tinnitus Retraining Therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Treatment Methods for Clinically Significant Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

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.

Estimated Enrollment:	200
Study Start Date:	October 1999
Study Completion Date:	September 2002
Primary Completion Date:	September 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with significant tinnitus

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013390

Locations

United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

James Henry, PhD

VA Medical Center, Portland

More Information

No publications provided

Responsible Party:	Henry, James - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00013390 History of Changes
Other Study ID Numbers:	C1995R
Study First Received:	March 14, 2001
Last Updated:	May 17, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Auditory, tinnitus

Additional relevant MeSH terms:

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013