NCT01693809

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 2, 2012

Status Verified

September 1, 2012

Enrollment Period

9 months

First QC Date

September 20, 2012

Last Update Submit

September 29, 2012

Conditions

Healthy Subjects

Keywords

CaffeineVestibular Evoked Myogenic Potentialsdizzinessvertigotinnitus

Outcome Measures

Primary Outcomes (1)

  • Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake.

    60 minutes

Study Arms (1)

Caffeine

EXPERIMENTAL

Caffeine 420mg, one time

Drug: Caffeine

Interventions

CaffeineDRUG
Caffeine

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Servidor Publico Estadual

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

DizzinessVertigoTinnitus

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNervous System DiseasesHearing Disorders

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Fabio Akira Suzuki, PhD

    Hospital do Servidor Publico Estadual

    STUDY CHAIR

  • Ana Maria Almeida Sousa, MD

    Hospital do Servidor Publico Estadual

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

October 2, 2012

Record last verified: 2012-09

Locations

BR(1)