N/A N=181 Randomized Treatment

Progressive Intervention Program for Tinnitus Management

Hearing Loss · Tinnitus

Bottom Line

View on ClinicalTrials.gov: NCT00371436 ↗

Enrolled (actual)

181

Serious AEs

—

Results posted

Apr 2015

Primary outcome: Primary: THI (Tinnitus Handicap Inventory) — 37.0; 43.0; 33.0; 40.0 scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Progressive Audiologic Tinnitus Management (Procedure); Usual Care (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY THI (Tinnitus Handicap Inventory)	37.0; 43.0; 33.0; 40.0	—

Summary

The purpose of this multi-site randomized clinical study is to test a model treatment program in a VA Audiology clinic, to evaluate its efficacy, ease of implementation, and acceptability to audiologists.

Eligibility Criteria

Inclusion Criteria

Veterans who:

Are outpatients at VA clinics in the vicinity of the James A. Haley VA Medical Center in Tampa, FL
Have clinically significant tinnitus
Have no significant language barrier
Are capable of and willing to fulfill all study requirements

Exclusion Criteria

Subjects must be free from any medical conditions that would interfere with study participation, e.g. medically or surgically treatable otologic disease; end-stage renal, pulmonary, or cardiovascular disease
Patients undergoing chemotherapy or radiation treatment
Patients with severe psychiatric disorders

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00371436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.