Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000106831
Ethics application status
Approved
Date submitted
13/12/2011
Date registered
23/01/2012
Date last updated
23/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vestibular evoked myogenic potentials in young adults
Scientific title
Investigating the vestibular evoked myogenic potential in a young population with normal hearing in order to standardize frequency stimulations
Secondary ID [1] 273609 0
NIL
Universal Trial Number (UTN)
U1111-1126-4050
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the study is conducted in healthy human volunteers belonging to the target population of the intervention. The problem(s) being investigated is healthy balance changes. 285396 0
The problem(s) being investigated is healthy balance changes. 285600 0
Condition category
Condition code
Ear 285576 285576 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study was performed the investigation of vestibular evoked myogenic potential in a young population with normal hearing. The examinations was conducted in only one day for each participant. The sample consists of 78 young adults. All data collection will take place over 1-year period. The vestibular evoked myogenic potentials will be captured in 156 ears of young adults with normal hearing, in the sternocleidomastoid muscle, the ipsilateral way through the averaging of 100 stimuli-tone bursts, frequency of 1000 Hz, intensity 95 dB HLN approximately for two hours. We used a specific equipment for capture potentials named EP25 of interacoustics.
Intervention code [1] 283886 0
Not applicable
Comparator / control treatment
'Not applicable'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286135 0
Normative values for test of balance. Audiometry tests were conducted to assess the presence of changes in hearing. Thus, we selected subjects with normal hearing to be submitted to the examination of vestibular evoked myogenic potential. These tests were done in one day.
Timepoint [1] 286135 0
The tonal audiometry and vestibular evoked myogenic potentials were performed on only one day for approximately two hours. The examinations of 78 patients, ie the complete sample was conducted during one year.
Secondary outcome [1] 295217 0
The analysis of the audiometry and potencial evoked myogenic potential were performed after data collection. Thus, the audiometry was carried out only to select the sample of normal individuals. So, after this, the subject was submitted to the vestibular evoked myogenic potentials exame. The potential was analyzed by tracing the demarcation of waves on the computer screen. Thus, we observe the parameters of latency and amplitude of these waves.
Timepoint [1] 295217 0
The tonal audiometry and vestibular evoked myogenic potentials were performed on only one day for approximately two hours. The examinations of 80 patients, ie the complete sample was conducted during one year.

Eligibility
Key inclusion criteria
Age between 18 and 55 years and normal hearing
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
exposure to noise or leisure, ear surgery, more than three ear infections in the current year, use of ototoxic medication, tinnitus, vertigo, dizziness or other changes cochleovestibular, presence of systemic changes that may contribute to pathologies cochleovestibular such as diabetes, hypertension, and / or hormonal changes

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment outside Australia
Country [1] 4016 0
Brazil
State/province [1] 4016 0
Alagoas

Funding & Sponsors
Funding source category [1] 284370 0
University
Name [1] 284370 0
Federal University of Sergipe
Country [1] 284370 0
Brazil
Primary sponsor type
Individual
Name
Aline Cabral de Oliveira Barreto
Address
G Street, number 38, Porto Sul, Aruana, aracaju, Sergipe, Brazil. Zip Code: 49039-282
Country
Brazil
Secondary sponsor category [1] 283308 0
Individual
Name [1] 283308 0
Pedro de Lemos Menezes
Address [1] 283308 0
Street Jorge de Lima, 113. Trapiche da Barra. Maceio, alagoas. Zip Code: 57010.200
Country [1] 283308 0
Brazil
Other collaborator category [1] 260395 0
Individual
Name [1] 260395 0
Nastassia Santos
Address [1] 260395 0
Street Jorge de Lima, 113. Trapiche da Barra. Maceio, alagoas. Zip Code: 57010.200
Country [1] 260395 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286331 0
Research Ethics Committee of the State University of Health Sciences of Alagoas
Ethics committee address [1] 286331 0
Street Jorge de Lima, 113. Trapiche da Barra. Maceio, alagoas. Zip Code: 57010.200
Ethics committee country [1] 286331 0
Brazil
Date submitted for ethics approval [1] 286331 0
20/01/2009
Approval date [1] 286331 0
06/03/2009
Ethics approval number [1] 286331 0
1010

Summary
Brief summary
This study aims to obtain data from subjects with normal hearing to allow the use of a new survey in the Brazilian population. This examination to evaluate the organ of balance and makes the diagnosis of diseases such as dizziness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33530 0
Address 33530 0
Country 33530 0
Phone 33530 0
Fax 33530 0
Email 33530 0
Contact person for public queries
Name 16777 0
aline Cabral de Oliveira Barreto
Address 16777 0
Street G, number 38, Porto Sul, Aruana, Aracaju, Sergipe, Brazil. Zip Code: 49039-282
Country 16777 0
Brazil
Phone 16777 0
+55 7999211700
Fax 16777 0
Email 16777 0
[email protected]
Contact person for scientific queries
Name 7705 0
aline Cabral de Oliveira Barreto
Address 7705 0
Street G, number 38, Porto Sul, Aruana, Aracaju, Sergipe, Brazil. Zip Code: 49039-282
Country 7705 0
Brazil
Phone 7705 0
+55 7999211700
Fax 7705 0
Email 7705 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.