Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000822088
Ethics application status
Approved
Date submitted
27/09/2010
Date registered
1/10/2010
Date last updated
1/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of speech recognition in individuals with and without speech recognition difficulties in noise.
Scientific title
Evaluation of speech recognition in individuals of normal hearing with and without speech recognition difficulty in noise, using sentences as stimulus.
Secondary ID [1] 252769 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Speech recognition. 258270 0
Condition category
Condition code
Ear 258461 258461 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 the individuals was applied. With this test was obtained the speech recognition thresholds in noise and the signal to noise ratio to each ear, using earphone TDH-39P.
This is a monaural test and consists of sentences that the individuals should repeat. The sentences and noise were presented using a Toshiba Digital Compact Disc Player - 4149 coupled to the audiometer Fonix (FA-12).
The noise intensity was fixed at 65 dB HL.
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] 257285 0
Not applicable
Comparator / control treatment
Speech recognition thresholds for normal hearing - Uncontrolled.

Two groups were studied: Group 1: individuals with clinical symptoms of difficulty to understand the speech in noise; Group 2: individuals without the clinical symptoms.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259305 0
The Portuguese Sentences Lists test to individuals with and without clinical symptoms of difficulty to understand the speech in noise was applied. With this test was obtained the speech recognition thresholds in noise and the signal to noise ratio to each ear.
For each ear was presented a list with 10 sentences. When the subject repeated the sentence correctly the intensity of the next sentence was reduced, if the answer was incorrect the following stimulus intensity was increased. With these values was calculated the average, resulting in speech recognition thresholds in noise.
Timepoint [1] 259305 0
Immediate results
Primary outcome [2] 259334 0
Signal to noise ratio.
From the average of the Speech recognition thresholds in noise was subtracted the noise intensity (fixed to 65 dB HL), obtaining the signal to noise ratio for each ear.
Timepoint [2] 259334 0
Immediate results
Secondary outcome [1] 265784 0
Nil
Timepoint [1] 265784 0
Nil

Eligibility
Key inclusion criteria
Hearing thresholds under 25 dB from 500 to 4000 Hz; no complaints of tinnitus and hyperacusis, with clinical symptoms of difficulty to understand the speech in noise for the Group 1, and without the clinical symptoms for the Group 2.
Minimum age
19 Years
Maximum age
32 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
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2939 0
Brazil
State/province [1] 2939 0

Funding & Sponsors
Funding source category [1] 257722 0
University
Name [1] 257722 0
Universidade Federal de Santa Maria
Country [1] 257722 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] 256938 0
Individual
Name [1] 256938 0
Maristela Julio Costa
Address [1] 256938 0
Professor Teixeira, 1284/403 - Centro, Santa Maria/RS. CEP: 97015-550
Country [1] 256938 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259771 0
Comite de Etica em Pesquisa da Universidade Federal de Santa Maria
Ethics committee address [1] 259771 0
Ethics committee country [1] 259771 0
Brazil
Date submitted for ethics approval [1] 259771 0
Approval date [1] 259771 0
Ethics approval number [1] 259771 0

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

Contacts
Principal investigator
Name 31705 0
Address 31705 0
Country 31705 0
Phone 31705 0
Fax 31705 0
Email 31705 0
Contact person for public queries
Name 14952 0
Karine Thais Becker
Address 14952 0
Pedo Santini, 177/109 - Nossa Senhora de Lourdes, Santa Maria/RS. CEP: 97060-480.
Country 14952 0
Brazil
Phone 14952 0
55-84063292
Fax 14952 0
Email 14952 0
[email protected]
Contact person for scientific queries
Name 5880 0
Karine Thais Becker
Address 5880 0
Pedo Santini, 177/109 - Nossa Senhora de Lourdes, Santa Maria/RS. CEP: 97060-480.
Country 5880 0
Brazil
Phone 5880 0
55-84063292
Fax 5880 0
Email 5880 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.