Tinnitus and Arterial Hypertension

Tinnitus and Arterial Hypertension.is There Any Relationship?

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

Study Overview

• Status: Unknown
• Conditions: Hearing Loss; Tinnitus; 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
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Valença, RJ, Brazil, 27660-000
      • Faculdade de Medicina de Valenca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients agedd between 40 and 50

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Normal subjects
AH; Arterial hypertension patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of tinnitus - have tinnitus x don't have tinnitus	The purpose of this study is to compare tinnitus incidence between patients with and without arterial hypertension.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of tinnitus - Tinnitus Handicap Inventory	Severity of tinnitus measured by Tinnitus Handicap Inventory, to evaluate differences between patients with and without arterial hypertension	Up to 6 months

Collaborators and Investigators

• Sponsor: Faculdade de Medicina de Valenca
• Collaborators: Federal University of São Paulo
• Investigators: Principal Investigator: Ricardo R Figueiredo, MD,MSc, Otosul, Valença Medical School

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ANTICIPATED): April 1, 2015
• Study Completion (ANTICIPATED): October 1, 2015

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 11, 2011
• First Posted (ESTIMATE): April 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: arterial hypertension; tinnitus; hearing loss; ototoxicity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hypertension; Hearing Loss; Deafness; Tinnitus
• Other Study ID Numbers: HAS