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

March 6, 2008 updated by: Faculdade de Medicina de Valenca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Volta Redonda, RJ, Brazil, 27255-650
        • OTOSUL,Otorrinolaringologia Sul-Fluminense

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
THI - Tinnitus Handicap Inventory
Time Frame: Months 3 and 6
Months 3 and 6

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS - Visual Analog Scale
Time Frame: Months 3 and 6
Months 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTOSUL 01/2007
  • FMV 01/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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