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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hospital do Servidor Publico Estadual.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ana Maria Almeida de Sousa, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier:
NCT01693809
First received: September 20, 2012
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Caffeine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy

Resource links provided by NLM:


Further study details as provided by Hospital do Servidor Publico Estadual:

Primary Outcome Measures:
  • Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caffeine
Caffeine 420mg, one time
Drug: Caffeine

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • hearing impairment
  • caffeine abuse 24 hours before the test
  • medication remains
  • hypertension, dyslipidemia, diabetes mellitus or sleep disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693809

Locations
Brazil
Hospital do Servidor Publico Estadual
São Paulo, Brazil
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Ana Maria Almeida de Sousa, MD, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier: NCT01693809     History of Changes
Other Study ID Numbers: 0127/11
Study First Received: September 20, 2012
Last Updated: September 29, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital do Servidor Publico Estadual:
Caffeine
Vestibular Evoked Myogenic Potentials
dizziness
vertigo
tinnitus

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014