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Effect of Caffeine Intake in Vestibular Function

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ClinicalTrials.gov Identifier: NCT02825199
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Alleluia Lima Losno Ledesma, Instituto Brasiliense de Otorrinolaringologia

Brief Summary:

Objective: Assess the effect of caffeine in the following vestibular function tests: Cervical Vestibular Evoked Potential (cVEMP), Ocular Vestibular Evoked Potential(oVEMP) and Caloric Test.

Methods: Randomized, prospective triple-blind, placebo controlled clinical trial. All participants underwent otoscopy, tympanometry, responded to the Profile of Mood State (POMS), submitted to the cVEMP, oVEMP and caloric tests. After that they received placebo or caffeine capsule (300mg) and repeated the procedures 45 minutes after.


Condition or disease Intervention/treatment Phase
Vertigo Diseases, Vestibular Caffeine Dietary Supplement: Caffeine Dietary Supplement: Non caffeine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Caffeine Intake in Vestibular Function: A Randomized Triple-Blind Controlled Trial
Study Start Date : February 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Caffeine group
All participants underwent otoscopy and tympanometry, responded to the Profile of Mood State (POMS), submitted to the cVEMP, oVEMP and caloric tests in that order. After that they received caffeine capsule (300mg). After 45 minutes they again responded to the POMS, repeated the cVEMP, oVEMP and caloric test.
Dietary Supplement: Caffeine
capsule: 300mg caffeine

Placebo Comparator: Non caffeine group
All participants underwent otoscopy and tympanometry, responded to the Profile of Mood State (POMS), submitted to the cVEMP, oVEMP and caloric tests in that order. After that they received placebo capsule (maize starch). After 45 minutes they again responded to the POMS, repeated the cVEMP, oVEMP and caloric test.
Dietary Supplement: Non caffeine
capsule: placebo (maize starch)




Primary Outcome Measures :
  1. wave latency - VEMP [ Time Frame: through study completion, an average of 3 months ]
  2. asymmetry rate - VEMP [ Time Frame: through study completion, an average of 3 months ]
  3. Peak slow velocity (PSV) - Caloric test [ Time Frame: through study completion, an average of 3 months ]
  4. Unilateral weakness or directional preponderance - Caloric test [ Time Frame: through study completion, an average of 3 months ]

Secondary Outcome Measures :
  1. Questionnaire - POMS [ Time Frame: through study completion, an average of 3 months ]
    Total of Mood Sates - It is a numerical scale that describes the participant's mood at that moment



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medical students volunteers
  • Had no hearing and/or vestibular complaints

Exclusion Criteria:

  • Problems in the cervical spine
  • Cardiovascular problems
  • Migraine
  • Metabolic disorders
  • Hormonal changes
  • Psychiatric disorders
  • Neurological diseases
  • Use of prescription drugs continuously
  • Smokers
  • Alcoholics
  • Illegal drug users

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825199


Locations
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Brazil
Instituto Brasiliense de Otorrinolaringologia (IBORL)
Brasilia, Distrito Federal, Brazil, 70710-149
Sponsors and Collaborators
Instituto Brasiliense de Otorrinolaringologia
Investigators
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Principal Investigator: Alleluia Ledesma, Audiologist Instituto Brasiliense de Otorrinolaringologia

Publications:

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Responsible Party: Alleluia Lima Losno Ledesma, Audiologist, Instituto Brasiliense de Otorrinolaringologia
ClinicalTrials.gov Identifier: NCT02825199     History of Changes
Other Study ID Numbers: IBOtorrinolaringologia
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be published in full on the master's dissertation
Additional relevant MeSH terms:
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Vestibular Diseases
Central Nervous System Stimulants
Vertigo
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Caffeine
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents