Multi-Site Randomized Clinical Study of Tinnitus Treatment Methods
Completed · Not applicable
Conditions studied: Tinnitus
In brief
The purpose of this multi-site randomized clinical study was to assess treatment outcomes for three forms of tinnitus treatment: Tinnitus Retraining Therapy (TRT), Tinnitus Masking, and Tinnitus Education (TED). There were four study sites: VAMC Audiology Clinics at Bay Pines, FL; Portland, OR; Seattle, WA; and San Diego, CA. Thirty-six subjects (Veterans) were enrolled into treatment at each site - 12 into each treatment group. Each subject received 18 months of treatment. Treatment appointments and outcome questionnaires occurred at 0, 3, 6, 12, and 18 months. Qualified subjects were initially randomized to one of the treatment groups or to a 6-month Waiting List group. Those in the Waiting List group completed outcome questionnaires at 3 and 6 months, and were randomized into one of the three treatment groups. They then received 18 months of treatment as above.
Key facts
- Study ID
- NCT00235807
- Run by
- US Department of Veterans Affairs
- People needed
- 144
- Starts
- 2004-06-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2011-03-24
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veterans with a) clinically significant tinnitus, and b) no significant language barrier.
You may not qualify if…
- 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; and patients with severe psychiatric disorders). Subjects must be free from such conditions and will be required to: (1) be between the ages of 2180; and (2) have a weighted error score of 10 or less on the Blessed Orientation-Memory Concentration Test.
Where it is running
- VA Medical Center, Portland — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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