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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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
protocol to collect the late latency auditory evoked potentials 3856 0
Condition category
Condition code
Ear 4050 4050 0 0
Normal ear development and function
Neurological 4051 4051 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3581 0
Diagnosis / Prognosis
Comparator / control treatment
no treatment as applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4949 0
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.
Timepoint [1] 4949 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.
Secondary outcome [1] 8345 0
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.
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.

Eligibility
Key inclusion criteria
Normal hearing and absence of neurologic´s complaints.
Minimum age
20 Years
Maximum age
31 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Deafness hearing and presence of neurologic´s complaints.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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] 1287 0
Brazil
State/province [1] 1287 0

Funding & Sponsors
Funding source category [1] 4033 0
Charities/Societies/Foundations
Name [1] 4033 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Address [1] 4033 0
Rua Pio XI, 1500. Alto da Lapa. Sao Paulo. CEP: 05468-901.
Country [1] 4033 0
Brazil
Primary sponsor type
Individual
Name
Luzia Maria Pozzobom Ventura
Address
Al Dr Octávio Pinheiro Brizola, 9-75. Vl Universitária. Bauru/SP. CEP: 17012-901.
Country
Brazil
Secondary sponsor category [1] 3626 0
Individual
Name [1] 3626 0
Orozimbo Alves Costa Filho
Address [1] 3626 0
Rua Silvio Marchione, 320. Vl Universitaria. Bauru/SP. CEP 17012-900.
Country [1] 3626 0
Brazil
Other collaborator category [1] 452 0
Individual
Name [1] 452 0
Katia de Freitas Alvarenga
Address [1] 452 0
Al Dr Octavio Pinheiro Brizola, 9-75. Vl Universitaria. Bauru/SP. CEP: 17012-901.
Country [1] 452 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6117 0
Comite de Etica em Pesquisa da Faculdade de Odontologia de Bauru da Universidade de Sao Paulo (FOB - USP).
Ethics committee address [1] 6117 0
Al Dr Octavio Pinheiro Brizola, 9-75. Vl Universitaria. Bauru/SP. CEP: 17012-901.
Ethics committee country [1] 6117 0
Brazil
Date submitted for ethics approval [1] 6117 0
01/04/2008
Approval date [1] 6117 0
05/05/2008
Ethics approval number [1] 6117 0
099/2006

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29060 0
Address 29060 0
Country 29060 0
Phone 29060 0
Fax 29060 0
Email 29060 0
Contact person for public queries
Name 12217 0
Luzia Maria Pozzobom Ventura
Address 12217 0
Al Dr Octávio Pinheiro Brizola, 9-75. Vl Universitária. Bauru/SP. CEP: 17012-901.
Country 12217 0
Brazil
Phone 12217 0
55(14)3235-8332
Fax 12217 0
Email 12217 0
luziampv@hotmail.com
Contact person for scientific queries
Name 3145 0
Dr Orozimbo Alves Costa Filho
Address 3145 0
Rua Silvio Marchione, 320. Vl Universitária. Bauru/SP. CEP 17012-900.
Country 3145 0
Brazil
Phone 3145 0
(5514)3234-2280
Fax 3145 0
Email 3145 0
cpa@centrinho.usp.br

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