Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Not Applicable

Completed

• Conditions: Tinnitus

• Registration Number: NCT00591994
• Lead Sponsor: Faculdade de Medicina de Valenca

Brief Summary

Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Status Verified: 2007-12
• Primary Completion: 2007-12
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-11
• Last Update Submitted: 2008-03-06
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• tinnitus for more than 6 months
• THI > 38
• no central acting drugs in the last 6 months
• tympanogram type A-n

Exclusion Criteria

• vascular and muscular tinnitus
• concomitant TMJ disorders
• abnormal otoscopy
• mixed and conductive hearing losses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
THI - Tinnitus Handicap Inventory	Months 3 and 6

Secondary Outcome Measures

Name	Time	Method
VAS - Visual Analog Scale	Months 3 and 6

Trial Locations

Locations (1)

OTOSUL,Otorrinolaringologia Sul-Fluminense; 🇧🇷 Volta Redonda, RJ, Brazil