Tinnitus and Arterial Hypertension

• Sponsor: Faculdade de Medicina de Valenca (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01333683
• Collaborator: Federal University of São Paulo (Other)
• Enrollment: 100
• Location: 1
• Duration (Months): 54
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tinnitus; Hearing Loss; 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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Tinnitus and Arterial Hypertension.is There Any Relationship?
• Study Start Date: Apr 1, 2011
• Anticipated Primary Completion Date: Apr 1, 2015
• Anticipated Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Control Normal subjects
AH Arterial hypertension patients

Outcome Measures

Primary Outcome Measures

1. Incidence of tinnitus - have tinnitus x don't have tinnitus [Up to 6 months]

   The purpose of this study is to compare tinnitus incidence between patients with and without arterial hypertension.

Secondary Outcome Measures

1. Severity of tinnitus - Tinnitus Handicap Inventory [Up to 6 months]

   Severity of tinnitus measured by Tinnitus Handicap Inventory, to evaluate differences between patients with and without arterial hypertension

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ricardo Rodrigues Figueiredo, M.D, MSc, Faculdade de Medicina de Valenca
• ClinicalTrials.gov Identifier: NCT01333683
• Other Study ID Numbers: HAS
• First Posted: Apr 12, 2011
• Last Update Posted: Mar 6, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Ricardo Rodrigues Figueiredo, M.D, MSc, Faculdade de Medicina de Valenca: tinnitus; hearing loss; arterial hypertension; ototoxicity
• Additional relevant MeSH terms: Hearing Loss; Deafness; Tinnitus; Hypertension

Study Results

No Results Posted as of Mar 6, 2015