Tinnitus and Arterial Hypertension

Hearing Loss Clinical Trial

Official title:

Tinnitus and Arterial Hypertension.is There Any Relationship?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01333683
• Other study ID #: HAS
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 7, 2011
• Last updated: March 4, 2015
• Start date: April 2011
• Est. completion date: October 2015

Study information

• Verified date: March 2015
• Source: Faculdade de Medicina de Valenca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 49 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Hypertension
• Deafness
• Hearing Loss
• Hypertension
• Tinnitus

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Valença	Valença	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Faculdade de Medicina de Valenca	Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No