Effects of Caffeine in Tinnitus
This study has been completed.
Sponsor:
Faculdade de Medicina de Valenca
Information provided by:
Faculdade de Medicina de Valenca
ClinicalTrials.gov Identifier:
NCT00628316
First received: February 25, 2008
Last updated: March 21, 2011
Last verified: February 2008
| Tracking Information | |||||
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| First Received Date ICMJE | February 25, 2008 | ||||
| Last Updated Date | March 21, 2011 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Tinnitus Handicap Inventory [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00628316 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Visual Analog Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Caffeine in Tinnitus | ||||
| Official Title ICMJE | Effects of Caffeine Consumption on Tinnitus Perception | ||||
| Brief Summary | Caffeine intake is reported by many authors to enhance the perception of tinnitus. The aim of this study is to determine the effects of 1 month caffeine intake reduction in the scores of validated questionnaire Tinnitus Handicap Inventory (THI) and in a visual-analog scale (VAS). |
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| Detailed Description | A group of 50 patients who takes more than 3 small cups (50 ml) of caffeine daily and have tinnitus will be asked to reduce caffeine intake for 1 month. Scores of THI and VAS will be taken before and after this period. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Tinnitus | ||||
| Intervention ICMJE | Dietary Supplement: caffeine
caffeine daily intake will be reduced form 150 ml per day |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00628316 | ||||
| Other Study ID Numbers ICMJE | FMV 001 2008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ricardo Rodrigues Figueiredo, MD, MSc, University of Valencia | ||||
| Study Sponsor ICMJE | Faculdade de Medicina de Valenca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Faculdade de Medicina de Valenca | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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