Effect of Caffeine Intake in Vestibular Function

NCT02825199 | Completed Phase 4

• 1 other identifier: IBOtorrinolaringologia
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertigo; Diseases, Vestibular; Caffeine

Outcome Measures

Primary Outcomes (4)

• wave latency - VEMP

  through study completion, an average of 3 months

• asymmetry rate - VEMP

  through study completion, an average of 3 months

• Peak slow velocity (PSV) - Caloric test

  through study completion, an average of 3 months

• Unilateral weakness or directional preponderance - Caloric test

  through study completion, an average of 3 months

Secondary Outcomes (1)

• Questionnaire - POMS

  through study completion, an average of 3 months

Study Arms (2)

Caffeine group

EXPERIMENTAL

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

Non caffeine group

PLACEBO COMPARATOR

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

Interventions

Caffeine DIETARY_SUPPLEMENT

capsule: 300mg caffeine

Caffeine group

Non caffeine DIETARY_SUPPLEMENT

capsule: placebo (maize starch)

Non caffeine group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Brasiliense de Otorrinolaringologia: lead

Study Sites (1)

Instituto Brasiliense de Otorrinolaringologia (IBORL)

Brasília, Federal District, 70710-149, Brazil

Location

Related Publications (10)

• Akin FW, Murnane OD, Proffitt TM. The effects of click and tone-burst stimulus parameters on the vestibular evoked myogenic potential (VEMP). J Am Acad Audiol. 2003 Nov;14(9):500-9; quiz 534-5. doi: 10.3766/jaaa.14.9.5.

  PMID: 14708838 BACKGROUND

• Akin FW, Murnane OD, Panus PC, Caruthers SK, Wilkinson AE, Proffitt TM. The influence of voluntary tonic EMG level on the vestibular-evoked myogenic potential. J Rehabil Res Dev. 2004 May;41(3B):473-80. doi: 10.1682/jrrd.2003.04.0060.

  PMID: 15543465 BACKGROUND

• Felipe L, Santos MA, Goncalves DU. Vestibular evoked myogenic potential (Vemp): evaluation of responses in normal subjects. Pro Fono. 2008 Oct-Dec;20(4):249-54. doi: 10.1590/s0104-56872008000400008.

  PMID: 19142468 BACKGROUND

• Carnauba AT, Lins OG, Soares Ido A, Andrade KC, Menezes Pde L. The impact of stimulation rates in vestibular evoked myogenic potential testing. Braz J Otorhinolaryngol. 2013 Sep-Oct;79(5):594-8. doi: 10.5935/1808-8694.20130106.

  PMID: 24141674 BACKGROUND

• Lim CL, Clouston P, Sheean G, Yiannikas C. The influence of voluntary EMG activity and click intensity on the vestibular click evoked myogenic potential. Muscle Nerve. 1995 Oct;18(10):1210-3. doi: 10.1002/mus.880181021. No abstract available.

  PMID: 7659119 BACKGROUND

• Wu CH, Young YH, Murofushi T. Tone burst-evoked myogenic potentials in human neck flexor and extensor. Acta Otolaryngol. 1999;119(7):741-4. doi: 10.1080/00016489950180351.

  PMID: 10687928 BACKGROUND

• Welgampola MS, Colebatch JG. Characteristics and clinical applications of vestibular-evoked myogenic potentials. Neurology. 2005 May 24;64(10):1682-8. doi: 10.1212/01.WNL.0000161876.20552.AA.

  PMID: 15911791 BACKGROUND

• Blakley BW, Wong V. Normal Values for Cervical Vestibular-Evoked Myogenic Potentials. Otol Neurotol. 2015 Jul;36(6):1069-73. doi: 10.1097/MAO.0000000000000752.

  PMID: 25839981 BACKGROUND

• Rosengren SM, Govender S, Colebatch JG. Ocular and cervical vestibular evoked myogenic potentials produced by air- and bone-conducted stimuli: comparative properties and effects of age. Clin Neurophysiol. 2011 Nov;122(11):2282-9. doi: 10.1016/j.clinph.2011.04.001. Epub 2011 May 6.

  PMID: 21550301 BACKGROUND

• Chihara Y, Iwasaki S, Ushio M, Murofushi T. Vestibular-evoked extraocular potentials by air-conducted sound: another clinical test for vestibular function. Clin Neurophysiol. 2007 Dec;118(12):2745-51. doi: 10.1016/j.clinph.2007.08.005. Epub 2007 Oct 1.

  PMID: 17905655 BACKGROUND

MeSH Terms

Conditions

Vertigo; Vestibular Diseases

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alleluia Ledesma, Audiologist

  Instituto Brasiliense de Otorrinolaringologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Audiologist

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: July 7, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)