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Trial registered on ANZCTR


Registration number
ACTRN12611000231943
Ethics application status
Approved
Date submitted
12/02/2011
Date registered
3/03/2011
Date last updated
4/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the potential of the organ of balance in a young population with normal hearing
Scientific title
Investigating the vestibular evoked myogenic potential in a young population with normal hearing in order to standardize frequency stimulations
Secondary ID [1] 253594 0
Nil
Universal Trial Number (UTN)
U1111-1119-6613
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 prevented is healthy balance changes. 261150 0
Condition category
Condition code
Ear 259309 259309 0 0
Normal ear development and function

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 80 young adults. All data collection will take place over 1-year period. The vestibular evoked myogenic potentials will be captured in 160 ears of young adults with normal hearing, in the sternocleidomastoid muscle, the ipsilateral way through the averaging of 200 stimuli-tone bursts, frequency of 250 Hz, intensity 95 dB HLN. We used a specific equipment for capture potentials named EP25 of interacoustics.
Intervention code [1] 258016 0
Not applicable
Comparator / control treatment
'Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262113 0
Normative values for test of balance. Audiometric examinations were performed to assess the presence of changes in hearing. Thus, we selected subjects with normal hearing for their consideration of vestibular evoked myogenic potential. These studies were performed in just one day, for each subject.
Timepoint [1] 262113 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.
Secondary outcome [1] 273188 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] 273188 0
Data analysis was performed within 6 months.

Eligibility
Key inclusion criteria
Aged 18 to 35 years and normal hearing
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
medical history of hearing impairment or vestibular disorders

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3178 0
Brazil
State/province [1] 3178 0
Alagoas

Funding & Sponsors
Funding source category [1] 258481 0
University
Name [1] 258481 0
Universidade de Sao Paulo
Address [1] 258481 0
Av. Bandeirantes, 3900 - Monte Alegre - Zip Code: 14049-900 Ribeirao Preto/Sao Paulo
Country [1] 258481 0
Brazil
Primary sponsor type
Individual
Name
Aline cabral de Oliveira
Address
Rua G, number 38. Porto Sul. Aruana, Aracaju. SE. Zip Code: 49039-282
Country
Brazil
Secondary sponsor category [1] 257622 0
Individual
Name [1] 257622 0
Pedro de Lemos Menezes
Address [1] 257622 0
Av. Bandeirantes, 3900 - Monte Alegre - Zip Code: 14049-900 Ribeirao Preto/Sao Paulo
Country [1] 257622 0
Brazil
Other collaborator category [1] 251814 0
Individual
Name [1] 251814 0
Jose Fernando Colafemina
Address [1] 251814 0
Av. Bandeirantes, 3900 - Monte Alegre - Zip Code: 14049-900 Ribeirao Preto/Sao Paulo
Country [1] 251814 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260458 0
Ethics Committe of Estadual University of Alagoas
Ethics committee address [1] 260458 0
Rua Jorge de Lima, 113. Trapiche da Barra. Maceio. Zip Code: 57010.200
Ethics committee country [1] 260458 0
Brazil
Date submitted for ethics approval [1] 260458 0
06/02/2009
Approval date [1] 260458 0
06/03/2009
Ethics approval number [1] 260458 0
1010

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

Contacts
Principal investigator
Name 32202 0
Address 32202 0
Country 32202 0
Phone 32202 0
Fax 32202 0
Email 32202 0
Contact person for public queries
Name 15449 0
Aline Cabral de Oliveira
Address 15449 0
Universidade Federal de Sergipe, Centro de Ciencias Biologicas e da Saude.
Av. Marechal Rondon, s/n Jd Rosa Elze
Sao Cristovao
49100-000 - Aracaju, SE - Brasil
Country 15449 0
Brazil
Phone 15449 0
+55 79- 2105-6805
Fax 15449 0
Email 15449 0
alinecabralbarreto@gmail.com
Contact person for scientific queries
Name 6377 0
Pedro de Lemos Menezes
Address 6377 0
Rua Jorge de Lima, 113. Trapiche da Barra. maceio. Alagoas. Zip Code: 57010.200
Country 6377 0
Brazil
Phone 6377 0
+55 82 33156813
Fax 6377 0
Email 6377 0
pedrodelemosmenezes@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary