NCT00013390CompletedPhase 2
Evaluation of Treatment Methods for Clinically Significant Tinnitus
US Department of Veterans Affairs1 site in 1 country200 target enrollmentStarted: October 1, 1999Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Tinnitus Severity Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with significant tinnitus
Exclusion Criteria
- Not provided
Arms & Interventions
1
Active Comparator
Tinnitus Masking
Intervention: Tinnitus Masking (Procedure)
2
Other
Tinnitus Retraining Therapy
Intervention: Tinnitus Retraining Therapy (Procedure)
Outcomes
Primary Outcomes
Tinnitus Severity Index
Time Frame: Baseline, 3 mo., 6 mo., 12 mo., 18 mo.
A well-developed scale currently in use at the Oregon Tinnitus Clinic.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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