Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography (piribedil)

Faculdade de Medicina de Valenca

Status: Completed

Conditions: Tinnitus

Treatments: Drug: piribedil

Study type: Interventional

Funder types: Other

Identifiers

NCT00591994

OTOSUL 01/2007

FMV 01/2006

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind