Effects of Caffeine in Tinnitus - Full Text View

Sponsored by:	Faculdade de Medicina de Valenca
Information provided by:	Faculdade de Medicina de Valenca
ClinicalTrials.gov Identifier:	NCT00628316

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

MedlinePlus related topics: Caffeine Tinnitus Toe Injuries and Disorders

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Effects of Caffeine Consumption on Tinnitus Perception

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
Estimated Study Completion Date:	December 2008
Estimated 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628316

Locations

Brazil, RJ
OTOSUL Otorrinolaringologia Sul-Fluminense
Volta Redonda, RJ, Brazil, 27255-650
Faculdade de Medicina de Valença
Valença, RJ, Brazil, 27600-000

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

No publications provided

Responsible Party:	University of Valencia ( Ricardo Rodrigues Figueiredo, MD, MSc )
Study ID Numbers:	FMV 001 2008
Study First Received:	February 25, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00628316 History of Changes
Health Authority:	Brazil: Ministry of Health

Keywords provided by Faculdade de Medicina de Valenca:

tinnitus, caffeine

Study placed in the following topic categories:

Caffeine citrate
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Phosphodiesterase Inhibitors
Otorhinolaryngologic Diseases

Citric Acid
Neurologic Manifestations
Central Nervous System Stimulants
Caffeine
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Caffeine citrate
Sensation Disorders
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Stimulants
Enzyme Inhibitors
Tinnitus

Ear Diseases
Pharmacologic Actions
Signs and Symptoms
Hearing Disorders
Phosphodiesterase Inhibitors
Therapeutic Uses
Neurologic Manifestations
Caffeine
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009