Evaluation of Treatment Methods for Clinically Significant Tinnitus

Phase 2

Completed

• Conditions: Tinnitus
• Interventions: Procedure: Tinnitus Masking; Procedure: Tinnitus Retraining Therapy

• Registration Number: NCT00013390
• Lead Sponsor: US Department of Veterans Affairs

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 available

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2001-03-14
• Study First Submitted QC: 2001-03-15
• Study First Posted: 2001-03-16
• Primary Completion: 2002-09
• Study Completion: 2002-09
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-17
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients with significant tinnitus

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Tinnitus Masking	Tinnitus Masking
2	Tinnitus Retraining Therapy	Tinnitus Retraining Therapy

Primary Outcome Measures

Name	Time	Method
Tinnitus Severity Index	Baseline, 3 mo., 6 mo., 12 mo., 18 mo.	A well-developed scale currently in use at the Oregon Tinnitus Clinic.

Trial Locations

Locations (1)

VA Medical Center, Portland; 🇺🇸 Portland, Oregon, United States