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Tinnitus and Arterial Hypertension

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01333683
First Posted: April 12, 2011
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca
  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:


Further study details as provided by Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca:

Primary Outcome Measures:
  • Incidence of tinnitus - have tinnitus x don't have tinnitus [ Time Frame: Up to 6 months ]
    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: October 2015
Estimated Primary Completion Date: April 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333683


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

Responsible Party: Ricardo Rodrigues Figueiredo, M.D, MSc, Faculdade de Medicina de Valenca
ClinicalTrials.gov Identifier: NCT01333683     History of Changes
Other Study ID Numbers: HAS
First Submitted: April 7, 2011
First Posted: April 12, 2011
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca:
tinnitus
hearing loss
arterial hypertension
ototoxicity

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