Evaluation of Treatment Methods for Clinically Significant Tinnitus

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 2

Conditions: Tinnitus

Treatments: Procedure: Tinnitus Masking; Procedure: Tinnitus Retraining Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00013390

C1995R

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with significant tinnitus

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1

Active Comparator group

Description:

Tinnitus Masking

Treatment:

Procedure: Tinnitus Masking

2

Other group

Description:

Tinnitus Retraining Therapy

Treatment:

Procedure: Tinnitus Retraining Therapy