piribedil: Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Sponsor

Faculdade de Medicina de Valenca (Other)

Overall Status

Completed

CT.gov ID

NCT00591994

Collaborator

(none)

100

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tinnitus	Drug: piribedil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

THI - Tinnitus Handicap Inventory [Months 3 and 6]

Secondary Outcome Measures

VAS - Visual Analog Scale [Months 3 and 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OTOSUL,Otorrinolaringologia Sul-Fluminense	Volta Redonda	RJ	Brazil	27255-650

Sponsors and Collaborators

Faculdade de Medicina de Valenca

Investigators

Study Chair: Ricardo R Figueiredo, M.D.,M.Sc, Faculdade de Medicina de Valença
Principal Investigator: Andréia A Azevedo, M.D., Otosul -Otorrinolaringologia Sul-Fluminense