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Tinnitus and Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01333683
Recruitment Status : Unknown
Verified March 2015 by Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca.
Recruitment status was:  Enrolling by invitation
First Posted : April 12, 2011
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca

Tracking Information
First Submitted Date April 7, 2011
First Posted Date April 12, 2011
Last Update Posted Date March 6, 2015
Study Start Date April 2011
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2011)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 11, 2011)		 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tinnitus and Arterial Hypertension
Official Title Tinnitus and Arterial Hypertension.is There Any Relationship?
Brief Summary 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
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients agedd between 40 and 50
Condition
  • Tinnitus
  • Hearing Loss
  • Arterial Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • Control
    Normal subjects
  • AH
    Arterial hypertension patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 11, 2011)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 49 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01333683
Other Study ID Numbers HAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca
Original Responsible Party Ricardo Rodrigues Figueiredo,MD, OTOSUL
Current Study Sponsor Faculdade de Medicina de Valenca
Original Study Sponsor Same as current
Collaborators Federal University of São Paulo
Investigators
Principal Investigator: Ricardo R Figueiredo, MD,MSc Otosul, Valença Medical School
PRS Account Faculdade de Medicina de Valenca
Verification Date March 2015