Multi-Site Randomized Clinical Study of Tinnitus Treatment Methods
1 other identifier
interventional
144
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 6, 2005
CompletedFirst Posted
Study publicly available on registry
October 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedMarch 24, 2011
March 1, 2011
2.4 years
October 6, 2005
March 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tinnitus Handicap Inventory (THI)
Baseline, 3 months, 6 months, 12 months, 18 months
Secondary Outcomes (1)
Tinnitus Severity Index (TSI)
Baseline, 3 months, 6 months, 12 months, 18 months
Study Arms (3)
1
OTHERshould contain an explanation of the nature of the study group (e.g., those with a condition and those without a condition; those with an exposure and those without an exposure).
2
OTHERshould contain an explanation of the nature of the study group (e.g., those with a condition and those without a condition; those with an exposure and those without an exposure).
3
OTHERshould contain an explanation of the nature of the study group (e.g., those with a condition and those without a condition; those with an exposure and those without an exposure).
Interventions
Sound therapy with Tinnitus Masking is intended to produce immediate relief from the discomfort caused by tinnitus (Vernon, 1977; 1987; Vernon, 1988). If maskers or combination units are used, the masking sound can be set at any level the patient chooses to attain maximum relief. Relief using masking noise can be accomplished using the external sound of the masker, which is generally a more acceptable sound than the tinnitus.
The TRT procedure adheres as closely as possible to the methodology described by Dr. Pawel Jastreboff. For TRT, sound therapy is used to facilitate long-term habituation to tinnitus (Jastreboff, 1999b).
TED represents tinnitus treatment that would typically be provided by audiologists using hearing aids and counseling (although for this study the counseling has been structured and expanded to be equivalent in length to the other two groups).
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Portland
Portland, Oregon, 97201, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Henry, PhD
VA Medical Center, Portland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
October 6, 2005
First Posted
October 10, 2005
Study Start
June 1, 2004
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
March 24, 2011
Record last verified: 2011-03