TinnitusNCT01333683
Tinnitus and Arterial Hypertension
An observational study of Tinnitus and Hearing Loss, run by Faculdade de Medicina de Valenca at 1 site in Brazil.
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 Read more about this study
- Who is it for?
- Ages 40 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Hearing Loss, Arterial Hypertension
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients agedd between 40 and 50
Who may be able to join
- age between 40 and 50
- arterial hypertension for group 1
- at least 5 years standing arterial hypertension
Who cannot join
- chronic noise exposure
- metabolic diseases
- family antecedents of hearing loss (except for presbycusis)
- pregnant women
- use of ototoxic drugs (except for anti-hypertensives)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina de Valença
Valença, Rio de Janeiro, 27660-000
About this study
Official title: 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
Read the 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
- Conditions
- Tinnitus, Hearing Loss, Arterial Hypertension
- Keywords
- tinnitus, hearing loss, arterial hypertension, ototoxicity
- Medical subject headings
- Tinnitus, Hearing Loss, Hypertension, Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Normal subjects | |
| AH | Arterial hypertension patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (1)
Severity of tinnitus - Tinnitus Handicap Inventory
Severity of tinnitus measured by Tinnitus Handicap Inventory, to evaluate differences between patients with and without arterial hypertension
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina de Valenca
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Ricardo Rodrigues Figueiredo, Faculdade de Medicina de Valenca
- Investigators
- Ricardo R Figueiredo, MD,MSc, Principal investigator, Otosul, Valença Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333683
- Sponsor's protocol ID
- HAS
- Status last verified
- Mar 2015
- First submitted
- 7 Apr 2011
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinnitus and Arterial Hypertension.is There Any Relationship?
- ClinicalTrials.gov ID
- NCT01333683
- Acronym / sponsor ID
- HAS
- Conditions
- Tinnitus, Hearing Loss, Arterial Hypertension
- Keywords
- tinnitus, hearing loss, arterial hypertension, ototoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Faculdade de Medicina de ValencaUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Apr 2011
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Normal subjects |
| AH | – | –Arterial hypertension patients |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients agedd between 40 and 50
Key inclusion criteria (3 listed)
- age between 40 and 50
- arterial hypertension for group 1
- at least 5 years standing arterial hypertension
Key exclusion criteria (5 listed)
- chronic noise exposure
- metabolic diseases
- family antecedents of hearing loss (except for presbycusis)
- pregnant women
- use of ototoxic drugs (except for anti-hypertensives)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Severity of tinnitus - Tinnitus Handicap Inventory
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo R Figueiredo, MD,MSc principal investigator
Otosul, Valença Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus and Hearing Loss, run by Faculdade de Medicina de Valenca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of tinnitus - have tinnitus x don't have tinnitus (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.