Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000408280
Ethics application status
Approved
Date submitted
23/05/2009
Date registered
2/06/2009
Date last updated
26/08/2024
Date data sharing statement initially provided
26/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Neural Processing of Speech Sounds in Hearing Impaired Children
Scientific title
The sensitivity of cortical evoked auditory potentials to speech sounds in hearing impaired children
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Impairment 4842 0
Condition category
Condition code
Ear 237185 237185 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
cortical evoked potentials will be performed while speech sounds are played via a loud speaker. This will be performed once, in a 30 minute session.
Intervention code [1] 236622 0
Not applicable
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238003 0
To show that acoustic changes in the spectral and temporal characteristics of speech (e.g., change in formant frequency or voice onset time) can be measured acoustically at the eardrum. a probe microphone and real ear measurement system will be used to record the sound at the ear drum.
Timepoint [1] 238003 0
This will be measured at the time of the research appointment, immediately prior to the measurement of the cortical evoked potentials (CAEPs)
Secondary outcome [1] 242268 0
To show that acoustical changes in speech sounds measured at the eardrum correlate with changes in the speech-evoked cortical auditory evoked potentials (CAEP). the CAEP will be measured via surface electrodes on the scalp
Timepoint [1] 242268 0
the speech-evoked cortical auditory evoked potentials (CAEP) will be measured at the time of the research appointment

Eligibility
Key inclusion criteria
Hearing loss
English speaking
Minimum age
3 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any individuals with known central nervous system (CNS) dysfunction, autism or attention deficit hyperactivity disorder (ADHD) will be excluded from the study.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
31/01/2010
Date of last data collection
Anticipated
Actual
31/01/2010
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 1802 0
New Zealand
State/province [1] 1802 0

Funding & Sponsors
Funding source category [1] 5005 0
University
Name [1] 5005 0
University of Auckland
Country [1] 5005 0
New Zealand
Primary sponsor type
University
Name
university of auckland
Address
261 Morrin Road,
Glen Innes
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 4525 0
Hospital
Name [1] 4525 0
Auckland Distract Health Board (ADHB) Audiology
Address [1] 4525 0
ADHB Audiology
Green Lane Clinical Centre
One Tree Hill
Auckland 1051
Country [1] 4525 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7106 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 7106 0
Ethics committee country [1] 7106 0
New Zealand
Date submitted for ethics approval [1] 7106 0
09/06/2009
Approval date [1] 7106 0
30/07/2009
Ethics approval number [1] 7106 0
4417
Ethics committee name [2] 315991 0
Ethics committee address [2] 315991 0
Ethics committee country [2] 315991 0
New Zealand
Date submitted for ethics approval [2] 315991 0
01/07/2009
Approval date [2] 315991 0
30/07/2009
Ethics approval number [2] 315991 0
4417

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

Contacts
Principal investigator
Name 29637 0
David Welch
Address 29637 0
M&HS BUILDING 507 - Bldg 507, 28 PARK AVE, GRAFTON, AUCKLAND, 1023, New Zealand
Country 29637 0
New Zealand
Phone 29637 0
+6493737599
Fax 29637 0
Email 29637 0
[email protected]
Contact person for public queries
Name 12884 0
Genevieve Mercer
Address 12884 0
26 Claremont St
Grafton
Auckland 1023
Country 12884 0
New Zealand
Phone 12884 0
+64 27 634 0438
Fax 12884 0
Email 12884 0
[email protected]
Contact person for scientific queries
Name 3812 0
Genevieve Mercer
Address 3812 0
26 Claremont St
Grafton
Auckland 1023
Country 3812 0
New Zealand
Phone 3812 0
+64 27 634 0438
Fax 3812 0
Email 3812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.