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Effects of Caffeine in Tinnitus

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ClinicalTrials.gov Identifier: NCT00628316
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 22, 2011
Sponsor:
Information provided by:
Faculdade de Medicina de Valenca

Study Description
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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).

Condition or disease Intervention/treatment Phase
Tinnitus Dietary Supplement: caffeine Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Caffeine Consumption on Tinnitus Perception
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Tinnitus
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Dietary Supplement: caffeine
    caffeine daily intake will be reduced form 150 ml per day

Outcome Measures
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Primary Outcome Measures :
  1. Tinnitus Handicap Inventory [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 30 days ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ricardo Rodrigues Figueiredo, MD, MSc, University of Valencia
ClinicalTrials.gov Identifier: NCT00628316     History of Changes
Other Study ID Numbers: FMV 001 2008
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: February 2008

Keywords provided by Faculdade de Medicina de Valenca:
tinnitus
caffeine

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Caffeine
 Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents