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Tinnitus and Arterial Hypertension

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Faculdade de Medicina de Valenca
ClinicalTrials.gov Identifier:
NCT01333683
First received: April 7, 2011
Last updated: April 11, 2011
Last verified: March 2011
History of Changes
  Purpose

Many authors link tinnitus to arterial hypertension. The aim of this study is to establish a possible relationship between them, analyze the severity of tinnitus related to arterial hypertension and analyze a possible influence of ototoxic drugs used to treat arterial hypertension


Condition
Tinnitus
Hearing Loss
Arterial Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tinnitus and Arterial Hypertension.is There Any Relationship?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Faculdade de Medicina de Valenca:

Primary Outcome Measures:
  • Incidence of tinnitus - have tinnitus x don't have tinnitus [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    The purpose of this study is to compare tinnitus incidence between patients with and without arterial hypertension.


Secondary Outcome Measures:
  • Severity of tinnitus - Tinnitus Handicap Inventory [ Time Frame: Up to 6 months ]
    Severity of tinnitus measured by Tinnitus Handicap Inventory, to evaluate differences between patients with and without arterial hypertension


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Normal subjects
AH
Arterial hypertension patients

Detailed Description:

Arterial hypertension has been cited as a possible tinnitus etiology. Vascular abnormalities associated with it may account for cochlear and central nervous system. However, a relationship between tinnitus and arterial hypertension has never been established. The aim of this study is to analyze this relationship, comparing groups with and without arterial hypertension and the incidence of tinnitus amongst them. Inclusion and exclusion criteria try to isolate arterial hypertension as the main etiological factor, as much as possible. Presbycusis, noise exposure, metabolical diseases and genetic factors will be ruled out. A comparison will be performed inside the arterial hypertension group between subgroups that use or not ototoxic medications, such as furosemide and beta-blockers

  Eligibility

Ages Eligible for Study:   40 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients agedd between 40 and 50

Criteria

Inclusion Criteria:

  • age between 40 and 50
  • arterial hypertension for group 1
  • at least 5 years standing arterial hypertension

Exclusion Criteria:

  • chronic noise exposure
  • metabolic diseases
  • family antecedents of hearing loss (except for presbycusis)
  • pregnant women
  • use of ototoxic drugs (except for anti-hypertensives)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333683

Locations
Brazil
Faculdade de Medicina de Valença
Valença, RJ, Brazil, 27660-000
Sponsors and Collaborators
Faculdade de Medicina de Valenca
Investigators
Principal Investigator: Ricardo R Figueiredo, MD,MSc Otosul, Valença Medical School
  More Information

No publications provided

Responsible Party: Ricardo Rodrigues Figueiredo,MD, OTOSUL
ClinicalTrials.gov Identifier: NCT01333683     History of Changes
Other Study ID Numbers: HAS
Study First Received: April 7, 2011
Last Updated: April 11, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Faculdade de Medicina de Valenca:
tinnitus
hearing loss
arterial hypertension
ototoxicity

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hypertension
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013