Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235807
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2005-10-06
Brief Title:
Multi-Site Randomized Clinical Study of Tinnitus Treatment Methods
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Multi-Site Randomized Clinical Study of Tinnitus Treatment Methods
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Although tinnitus is especially problematic for Veterans the DVA has no established protocol for tinnitus rehabilitation We recently completed a randomized clinical trial to evaluate the efficacy of tinnitus treatment for veterans Tinnitus Masking and Tinnitus Retraining Therapy TRT were both shown to be effective for the majority of Veterans treated with these methods by expert tinnitus clinicians The objective of the present study was to determine if the same level of treatment efficacy observed in the previous study could be obtained by typical VA audiologists in their clinical environment In addition a third group was added called Tinnitus Education TED which served as a control group for nonspecific effects of treatment using a standardized protocol of hearing aids and education
Veterans with clinically significant tinnitus were recruited to receive treatment with Masking TRT or TED in Audiology Clinics at the Bay Pines Portland San Diego and Seattle VAMCs There were three Treatment Audiologists at each of the sites one for each of the three treatment methods Each method uses a variation of sound therapy and of educational counseling Sound therapy involves the use of wearable ear-level devices including sound generators maskers hearing aids or combination devices hearing aid and masker combined Only the TED group was restricted to the use of hearing aids only note TED subjects who did not require hearing aids were the only subjects in this study who did not receive ear-level devices TRT uses a structured counseling protocol that teaches concepts that are unique to TRT The Masking protocol has been created to match the TRT counseling with respect to comparable formatting and length of counseling sessions but containing information specific to the concepts of Masking The TED counseling protocol is similarly matched in format and length but the information conveyed is of a more generic nature general audiologic counseling information Assessment of outcomes utilized questionnaires that were administered at intervals before during and after the 18 months of treatment
Potential participants at all sites were telephone-screened by the Project Audiologist in Portland to determine if the tinnitus is a clinically significant problem warranting 18 months of treatment Veterans who passed the screening were scheduled to meet with the Research Coordinator RC at the respective study site At this first visit Veterans were consented completed questionnaires and were then informed as to their group placement Per a randomization schedule they were placed into one of the three treatment groups or into the 6-month waiting list group with treatment starting 6 months later At the initial evaluation with the respective Treatment Audiologist a tinnitus verbal interview was administered hearing and tinnitus testing were performed and ear mold impressions were taken to order the custom ear-level devices The Veteran returned approximately 3-4 weeks later to be fitted with the devices and to receive the counselingeducation that initiates treatment Subjects returned for follow-up treatment at 3 6 12 and 18 months At the follow-up appointments the RC collected and checked the questionnaires and the Treatment Audiologist administered the follow-up verbal interview and repeated the counseling protocol
Veterans with clinically significant tinnitus were recruited to receive treatment with Masking TRT or TED in Audiology Clinics at the Bay Pines Portland San Diego and Seattle VAMCs There were three Treatment Audiologists at each of the sites one for each of the three treatment methods Each method uses a variation of sound therapy and of educational counseling Sound therapy involves the use of wearable ear-level devices including sound generators maskers hearing aids or combination devices hearing aid and masker combined Only the TED group was restricted to the use of hearing aids only note TED subjects who did not require hearing aids were the only subjects in this study who did not receive ear-level devices TRT uses a structured counseling protocol that teaches concepts that are unique to TRT The Masking protocol has been created to match the TRT counseling with respect to comparable formatting and length of counseling sessions but containing information specific to the concepts of Masking The TED counseling protocol is similarly matched in format and length but the information conveyed is of a more generic nature general audiologic counseling information Assessment of outcomes utilized questionnaires that were administered at intervals before during and after the 18 months of treatment
Potential participants at all sites were telephone-screened by the Project Audiologist in Portland to determine if the tinnitus is a clinically significant problem warranting 18 months of treatment Veterans who passed the screening were scheduled to meet with the Research Coordinator RC at the respective study site At this first visit Veterans were consented completed questionnaires and were then informed as to their group placement Per a randomization schedule they were placed into one of the three treatment groups or into the 6-month waiting list group with treatment starting 6 months later At the initial evaluation with the respective Treatment Audiologist a tinnitus verbal interview was administered hearing and tinnitus testing were performed and ear mold impressions were taken to order the custom ear-level devices The Veteran returned approximately 3-4 weeks later to be fitted with the devices and to receive the counselingeducation that initiates treatment Subjects returned for follow-up treatment at 3 6 12 and 18 months At the follow-up appointments the RC collected and checked the questionnaires and the Treatment Audiologist administered the follow-up verbal interview and repeated the counseling protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None