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Clinical Trials/NCT00013390
NCT00013390CompletedPhase 2

Evaluation of Treatment Methods for Clinically Significant Tinnitus

US Department of Veterans Affairs2 sites in 1 country200 target enrollmentStarted: October 1999Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
200
Locations
2
Primary Endpoint
Tinnitus Severity Index
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

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

Sponsor Class
Fed

Study Sites (2)

Loading locations...

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