Evaluation of Treatment Methods for Clinically Significant Tinnitus

NCT00013390 | Completed Phase 2

• 1 other identifier: C1995R
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Auditory, tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Severity Index

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

  Baseline, 3 mo., 6 mo., 12 mo., 18 mo.

Study Arms (2)

1

ACTIVE COMPARATOR

Tinnitus Masking

Procedure: Tinnitus Masking

2

OTHER

Tinnitus Retraining Therapy

Procedure: Tinnitus Retraining Therapy

Interventions

Tinnitus Masking PROCEDURE

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).

1

Tinnitus Retraining Therapy PROCEDURE

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.

Also known as: TRT

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with significant tinnitus

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Henry, PhD

  VA Medical Center, Portland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 14, 2001
• First Posted: March 16, 2001
• Study Start: October 1, 1999
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: May 18, 2011

Record last verified: 2011-05

Locations

US (1)