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
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Tinnitus |
Dietary Supplement: caffeine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Caffeine Consumption on Tinnitus Perception |
Resource links provided by NLM:
Further study details as provided by Faculdade de Medicina de Valenca:
Primary Outcome Measures:
- Tinnitus Handicap Inventory [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual Analog Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Dietary Supplement: caffeine
caffeine daily intake will be reduced form 150 ml per day
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- tinnitus for more than 6 months
- THI > 38
- no central acting drugs in the last 6 months
- tympanogram type A-n
- daily intake of caffeine greater than 150 ml
Exclusion Criteria:
- vascular and muscular tinnitus
- concomitant TMJ disorders
- abnormal otoscopy
- mixed and conductive hearing losses
- Ménière disease
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628316
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628316
Locations
| Brazil | |
| Faculdade de Medicina de Valença | |
| Valença, RJ, Brazil, 27600-000 | |
| OTOSUL Otorrinolaringologia Sul-Fluminense | |
| Volta Redonda, RJ, Brazil, 27255-650 | |
Sponsors and Collaborators
Faculdade de Medicina de Valenca
Investigators
| Study Chair: | Ricardo R Figueiredo, MD,MSc | Faculdade de Medicina de Valença |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ricardo Rodrigues Figueiredo, MD, MSc, University of Valencia |
| ClinicalTrials.gov Identifier: | NCT00628316 History of Changes |
| Other Study ID Numbers: | FMV 001 2008 |
| Study First Received: | February 25, 2008 |
| Last Updated: | March 21, 2011 |
| Health Authority: | Brazil: Ministry of Health |
Keywords provided by Faculdade de Medicina de Valenca:
|
tinnitus caffeine |
Additional relevant MeSH terms:
|
Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Sensation Disorders Signs and Symptoms Caffeine Central Nervous System Agents Central Nervous System Stimulants |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Phosphodiesterase Inhibitors Physiological Effects of Drugs Purinergic Agents Purinergic Antagonists Purinergic P1 Receptor Antagonists Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015