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

History of Changes

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:

MedlinePlus related topics: Caffeine Tinnitus

U.S. FDA Resources

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:

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 (Adult, Senior)
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:

Tinnitus Center Homepage This link exits the ClinicalTrials.gov site


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 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

ClinicalTrials.gov processed this record on September 26, 2016

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