Healthy SubjectsPhase 4NCT01693809
The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy Subjects
A Phase 4 study testing Caffeine in people with Healthy Subjects, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
Trial summary
The principal aim of this study is to evaluate the presence of changes in cervical vestibular evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects. Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service of the hospital. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 4
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
Who cannot join
- hearing impairment
- caffeine abuse 24 hours before the test
- medication remains
- hypertension, dyslipidemia, diabetes mellitus or sleep disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy
The principal aim of this study is to evaluate the presence of changes in cervical vestibular evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.
Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service of the hospital.
- Conditions
- Healthy Subjects
- Being tested
- Caffeine
- Keywords
- Caffeine, Vestibular Evoked Myogenic Potentials, dizziness, vertigo, tinnitus
- Medical subject headings
- Dizziness, Vertigo, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Caffeine 420mg, one time Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Maria Almeida de Sousa, Hospital do Servidor Publico Estadual
- Investigators
- Fabio Akira Suzuki, PhD, Study chair, Hospital do Servidor Publico EstadualAna Maria Almeida Sousa, MD, Principal investigator, Hospital do Servidor Publico Estadual
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693809
- Sponsor's protocol ID
- 0127/11
- Status last verified
- Sep 2012
- First submitted
- 20 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy
- ClinicalTrials.gov ID
- NCT01693809
- Acronym / sponsor ID
- 0127/11
- Conditions
- Healthy Subjects
- Keywords
- Caffeine, Vestibular Evoked Myogenic Potentials, dizziness, vertigo, tinnitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 26 Sep 2012 (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.
The principal aim of this study is to evaluate the presence of changes in cervical vestibular evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.
Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service of the hospital.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: CaffeineCaffeine 420mg, one time |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (4 listed)
- hearing impairment
- caffeine abuse 24 hours before the test
- medication remains
- hypertension, dyslipidemia, diabetes mellitus or sleep disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine | Drug | Caffeine |
Primary outcome
Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake.
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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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.
Fabio Akira Suzuki, PhD study chair
Hospital do Servidor Publico Estadual
Ana Maria Almeida Sousa, MD principal investigator
Hospital do Servidor Publico Estadual
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caffeine in people with Healthy Subjects, run by Hospital do Servidor Publico Estadual 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 1 inclusion and 4 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 2 Oct 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake. (time frame: 60 minutes). 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 2 Oct 2012.