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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
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Scientific title
Investigating the vestibular evoked myogenic potential in a young population with normal hearing in order to standardize frequency stimulations
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Secondary ID [1]
253594
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Nil
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Universal Trial Number (UTN)
U1111-1119-6613
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Trial acronym
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Linked study record
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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.
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Condition category
Condition code
Ear
259309
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0
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Normal ear development and function
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
258016
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Not applicable
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Comparator / control treatment
'Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Data analysis was performed within 6 months.
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Eligibility
Key inclusion criteria
Aged 18 to 35 years and normal hearing
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
medical history of hearing impairment or vestibular disorders
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/01/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3178
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Brazil
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State/province [1]
3178
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Alagoas
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Universidade de Sao Paulo
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Address [1]
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Av. Bandeirantes, 3900 - Monte Alegre - Zip Code: 14049-900 Ribeirao Preto/Sao Paulo
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Country [1]
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Brazil
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Primary sponsor type
Individual
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Name
Aline cabral de Oliveira
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Address
Rua G, number 38. Porto Sul. Aruana, Aracaju. SE. Zip Code: 49039-282
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Country
Brazil
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Secondary sponsor category [1]
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Individual
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Name [1]
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Pedro de Lemos Menezes
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Address [1]
257622
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Av. Bandeirantes, 3900 - Monte Alegre - Zip Code: 14049-900 Ribeirao Preto/Sao Paulo
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Country [1]
257622
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Brazil
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Other collaborator category [1]
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Individual
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Name [1]
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Jose Fernando Colafemina
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Address [1]
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Av. Bandeirantes, 3900 - Monte Alegre - Zip Code: 14049-900 Ribeirao Preto/Sao Paulo
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Country [1]
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Brazil
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics Committe of Estadual University of Alagoas
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Ethics committee address [1]
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Rua Jorge de Lima, 113. Trapiche da Barra. Maceio. Zip Code: 57010.200
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Ethics committee country [1]
260458
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Brazil
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Date submitted for ethics approval [1]
260458
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06/02/2009
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Approval date [1]
260458
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06/03/2009
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Ethics approval number [1]
260458
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1010
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
32202
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Email
32202
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Contact person for public queries
Name
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Aline Cabral de Oliveira
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Address
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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
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Country
15449
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Brazil
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Phone
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+55 79- 2105-6805
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Fax
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Email
15449
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[email protected]
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Contact person for scientific queries
Name
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Pedro de Lemos Menezes
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Address
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Rua Jorge de Lima, 113. Trapiche da Barra. maceio. Alagoas. Zip Code: 57010.200
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Country
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Brazil
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Phone
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+55 82 33156813
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Fax
6377
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Email
6377
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[email protected]
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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.
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