The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy Subjects

September 29, 2012 updated by: Ana Maria Almeida de Sousa, Hospital do Servidor Publico Estadual

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Hospital do Servidor Publico Estadual

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • hearing impairment
  • caffeine abuse 24 hours before the test
  • medication remains
  • hypertension, dyslipidemia, diabetes mellitus or sleep disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caffeine
Caffeine 420mg, one time
Drug: Caffeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake.
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Servidor Publico Estadual

Investigators

  • Study Chair: Fabio Akira Suzuki, PhD, Hospital do Servidor Publico Estadual
  • Principal Investigator: Ana Maria Almeida Sousa, MD, Hospital do Servidor Publico Estadual

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

September 29, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0127/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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