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NCT01693809 Clinical Trial

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

Healthy Subjects Clinical Trial

Official title:
The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01693809
Other study ID # 0127/11
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received September 20, 2012
Last updated September 29, 2012
Start date January 2012
Est. completion date January 2013

Study information
Verified date September 2012
Source Hospital do Servidor Publico Estadual
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date January 2013
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility 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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• Caffeine

Locations
Country Name City State
Brazil Hospital do Servidor Publico Estadual São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Hospital do Servidor Publico Estadual

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake. 60 minutes No
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