The Effects of Caffeine on Vestibular Evoked Myogenic Pot... | NCT01693809

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

NCT01693809

Sponsor

Hospital do Servidor Publico Estadual

Status

Unknown status

Last Update Posted

Oct 2, 2012Estimated

Enrollment

25Estimated

Phase

Phase 4

Conditions

Healthy Subjects

Interventions

Caffeine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Oct 2012Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Sep 20, 2012

First Submission Date that Met QC Criteria

Sep 24, 2012

First Posted Date

Sep 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2012

Last Update Posted Date

Oct 2, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ana Maria Almeida de Sousa, MD, Hospital do Servidor Publico EstadualPrincipal Investigator

Lead Sponsor

Hospital do Servidor Publico EstadualOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Caffeine	Experimental	Caffeine 420mg, one time	Drug: Caffeine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caffeine	Drug		Caffeine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabio Akira Suzuki, PhD	Hospital do Servidor Publico Estadual	Study Chair
Ana Maria Almeida Sousa, MD	Hospital do Servidor Publico Estadual	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital do Servidor Publico Estadual		São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D004244	Dizziness
D014717	Vertigo
D014012	Tinnitus

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002110	Caffeine

Ancestor Terms

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones

Browse Leaves

Not provided

Browse Branches

Not provided