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Trial registered on ANZCTR
Registration number
ACTRN12608000636358
Ethics application status
Approved
Date submitted
22/10/2008
Date registered
16/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Protocol to collect the late latency auditory evoked potentials in ten adults with normal hearing
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Scientific title
A comparison of the Subtraction of the Ocular´s Artifact and the Control of the Rejection´s Limit protocols, in the record of the late latency auditory evoked potentials in ten adults with normal hearing
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Universal Trial Number (UTN)
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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:
protocol to collect the late latency auditory evoked potentials
3856
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Condition category
Condition code
Ear
4050
4050
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0
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Normal ear development and function
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Neurological
4051
4051
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0
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Studies of the normal brain and nervous system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Comparison of two diagnostic´s protocols (subtraction of the ocular´s artifact and control of the rejection´s limit) to collect the late latency auditory evoked potentials. Both protocols are the intervention, which were compared for the selection of the greatest adequate to collect the late latency auditory evoked potentials. Prospective study by the aplication of these two methods in ten normally hearing adults, by the utilization of the equipment with two record´s channels, and controlling the artifact produced by the ocular´s movement. The subtraction of the ocular´s artifact protocol consist in the subtraction of the ocular´s movement registered in the captivating of the late latency auditory evoked potentials. Unfavourable, the control of the rejection´s limit protocol consist in the no captivating of the ocular´s movement while the record of the late latency auditory evoked potentials. The application of these protocols in the participants remained two months and both protocols were applied only one session in each participant, one followed another, in the same session. The application of each protocol remain about ten minutes.
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Intervention code [1]
3581
0
Diagnosis / Prognosis
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Comparator / control treatment
no treatment as applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The two methods were eficcient to control of the ocular movement's artifact while the collection of the late latency auditory evoked potentials. This is observed after the analysis of the latency and amplitude's values of the late latency auditory evoked potentials and the application of the paired test t statistical's method.
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Assessment method [1]
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Timepoint [1]
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Two months after the start of the study. Throughout the application of the two protocols and after the end of the whole sessions. Treatment wasn't used. Diagnostic's protocol was used.
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Secondary outcome [1]
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Higher amplitude's values were observed in the method of the control of the rejection's limit. This is checked by the analysis of the amplitude's values and the application of the paired test t statistical's method.
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Assessment method [1]
8345
0
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Timepoint [1]
8345
0
Two months after the start of the study. Throughout the application of the two protocols and after the end of the whole sessions. Treatment wasn't used. Diagnostic's protocol was used.
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Eligibility
Key inclusion criteria
Normal hearing and absence of neurologic´s complaints.
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Minimum age
20
Years
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Maximum age
31
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
Deafness hearing and presence of neurologic´s complaints.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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
6/05/2008
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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
10
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
1287
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Brazil
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State/province [1]
1287
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Funding & Sponsors
Funding source category [1]
4033
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Charities/Societies/Foundations
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Name [1]
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Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
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Address [1]
4033
0
Rua Pio XI, 1500. Alto da Lapa. Sao Paulo. CEP: 05468-901.
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Country [1]
4033
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Brazil
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Primary sponsor type
Individual
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Name
Luzia Maria Pozzobom Ventura
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Address
Al Dr Octávio Pinheiro Brizola, 9-75. Vl Universitária. Bauru/SP. CEP: 17012-901.
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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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Orozimbo Alves Costa Filho
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Address [1]
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Rua Silvio Marchione, 320. Vl Universitaria. Bauru/SP. CEP 17012-900.
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Country [1]
3626
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Brazil
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Other collaborator category [1]
452
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Individual
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Name [1]
452
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Katia de Freitas Alvarenga
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Address [1]
452
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Al Dr Octavio Pinheiro Brizola, 9-75. Vl Universitaria. Bauru/SP. CEP: 17012-901.
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Country [1]
452
0
Brazil
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Comite de Etica em Pesquisa da Faculdade de Odontologia de Bauru da Universidade de Sao Paulo (FOB - USP).
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Ethics committee address [1]
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Al Dr Octavio Pinheiro Brizola, 9-75. Vl Universitaria. Bauru/SP. CEP: 17012-901.
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Ethics committee country [1]
6117
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Brazil
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Date submitted for ethics approval [1]
6117
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01/04/2008
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Approval date [1]
6117
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05/05/2008
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Ethics approval number [1]
6117
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099/2006
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Summary
Brief summary
To compare two methods to collect the late latency auditory evoked potentials, by the utilization of equipment with two record´s channels and controlling the artifact produced by the ocular's movement.
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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
29060
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Phone
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Fax
29060
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Email
29060
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Contact person for public queries
Name
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Luzia Maria Pozzobom Ventura
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Address
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Al Dr Octávio Pinheiro Brizola, 9-75. Vl Universitária. Bauru/SP. CEP: 17012-901.
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Country
12217
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Brazil
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Phone
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55(14)3235-8332
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Fax
12217
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Orozimbo Alves Costa Filho
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Address
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Rua Silvio Marchione, 320. Vl Universitária. Bauru/SP. CEP 17012-900.
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Country
3145
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Brazil
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Phone
3145
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(5514)3234-2280
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Fax
3145
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Email
3145
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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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