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Effects of Caffeine in Tinnitus

This study has been completed.
Sponsor:
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
  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:
    Dietary Supplement: caffeine
    caffeine daily intake will be reduced form 150 ml per day
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 November 20, 2014