Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date † | July 27, 2005 | ||||||||
Last Updated Date | February 10, 2009 | ||||||||
Start Date † | November 2005 | ||||||||
Current Primary Outcome Measures † |
|
||||||||
Original Primary Outcome Measures † |
|
||||||||
Change History | Complete list of historical versions of study NCT00124800 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
Change in subjective ratings of tinnitus loudness, annoyance and awareness [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus | ||||||||
Official Title † | The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus | ||||||||
Brief Summary | The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT. |
||||||||
Detailed Description | The specific aims of the study are to:
|
||||||||
Study Phase | Phase I | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † | Tinnitus | ||||||||
Intervention † |
|
||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 40 | ||||||||
Estimated Completion Date | June 2009 | ||||||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts †† |
|
||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00124800 | ||||||||
Responsible Party | Carol Bauer, Professor of Otolaryngology, SIU School of Medicine | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Tinnitus Research Consortium | ||||||||
Collaborators †† | |||||||||
Investigators † |
|
||||||||
Information Provided By | Tinnitus Research Consortium | ||||||||
Verification Date | February 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |