NCT01333683

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

April 7, 2011

Last Update Submit

March 4, 2015

Conditions

TinnitusHearing LossArterial Hypertension

Keywords

tinnitushearing lossarterial hypertensionototoxicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Severity of tinnitus - Tinnitus Handicap Inventory

    Up to 6 months

Study Arms (2)

Control

Normal subjects

AH

Arterial hypertension patients

Eligibility Criteria

Age40 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients agedd between 40 and 50

You may qualify if:

  • age between 40 and 50
  • arterial hypertension for group 1
  • at least 5 years standing arterial hypertension

You may not qualify if:

  • chronic noise exposure
  • metabolic diseases
  • family antecedents of hearing loss (except for presbycusis)
  • pregnant women
  • use of ototoxic drugs (except for anti-hypertensives)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina de Valença

Valença, Rio de Janeiro, 27660-000, Brazil

Location

MeSH Terms

Conditions

TinnitusHearing LossHypertensionOtotoxicity

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesPathologic ProcessesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Officials

  • Ricardo R Figueiredo, MD,MSc

    Otosul, Valença Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, MSc

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 12, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

BR(1)