Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000799055
Ethics application status
Approved
Date submitted
20/08/2010
Date registered
27/09/2010
Date last updated
27/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Speech recognition in right and left handers normal hearing: there is a difference?
Scientific title
Speech recognition in noise in right and left handers normal hearing: there is a difference?
Secondary ID [1] 252522 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evaluation of hearing loss 258013 0
Condition category
Condition code
Ear 258180 258180 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
The Portuguese Sentences Lists test to right and left handers was applied. With this test was obtained the speech recognition thresholds in noise and the signal to noise ratio to each ear.
The application was made in a single session of 20 minutes and was applied only once in each participant. The total study duration was 4 months.
Intervention code [1] 257054 0
Not applicable
Comparator / control treatment
Speech recognition thresholds for normal hearing - Uncontrolled.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259038 0
The Portuguese Sentences Lists test to right and left handers was applied. With this test was obtained the speech recognition thresholds in noise and the signal to noise ratio to each ear.
Timepoint [1] 259038 0
Immediate result
Secondary outcome [1] 265289 0
Signal to noise ratio.
From the average of the Speech recognition thresholds in noise was subtracted the noise intensity (fixed to 65 dBNA), obtaining the signal to noise ratio for each ear.
Timepoint [1] 265289 0
Immediate results

Eligibility
Key inclusion criteria
Hearing thresholds under 25 dB from 500 to 4000 Hz; no complaints of tinnitus and hyperacusis.
Minimum age
18 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hearing loss; complaints of tinnitus and hyperacusis.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 2824 0
Brazil
State/province [1] 2824 0
Rio Grande do Sul.

Funding & Sponsors
Funding source category [1] 257501 0
University
Name [1] 257501 0
Universidade Federal de Santa Maria
Country [1] 257501 0
Brazil
Primary sponsor type
Individual
Name
Karine Thais Becker
Address
Pedro Santini, 177/109 - Nossa Senhora de Lourdes, Santa Maria/RS. CEP: 97060-480.
Country
Brazil
Secondary sponsor category [1] 256734 0
Individual
Name [1] 256734 0
Maristela Julio Costa
Address [1] 256734 0
Professor Teixeira, 1284/403 - Centro, Santa Maria/RS. CEP: 97015-550
Country [1] 256734 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259529 0
Comite de Etica em Pesquisa da Universidade Federal de Santa Maria
Ethics committee address [1] 259529 0
Ethics committee country [1] 259529 0
Brazil
Date submitted for ethics approval [1] 259529 0
Approval date [1] 259529 0
Ethics approval number [1] 259529 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31549 0
Address 31549 0
Country 31549 0
Phone 31549 0
Fax 31549 0
Email 31549 0
Contact person for public queries
Name 14796 0
Karine Thais Becker
Address 14796 0
Pedo Santini, 177/109 - Nossa Senhora de Lourdes, Santa Maria/RS. CEP: 97060-480.
Country 14796 0
Brazil
Phone 14796 0
55-84063292
Fax 14796 0
Email 14796 0
[email protected]
Contact person for scientific queries
Name 5724 0
Karine Thais Becker
Address 5724 0
Pedo Santini, 177/109 - Nossa Senhora de Lourdes, Santa Maria/RS. CEP: 97060-480.
Country 5724 0
Brazil
Phone 5724 0
55-84063292
Fax 5724 0
Email 5724 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.