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Trial registered on ANZCTR
Registration number
ACTRN12609000408280
Ethics application status
Not yet submitted
Date submitted
23/05/2009
Date registered
2/06/2009
Date last updated
2/06/2009
Type of registration
Prospectively registered
Titles & IDs
Public title
The Neural Processing of Speech Sounds in Hearing Impaired Children
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Scientific title
The sensitivity of cortical evoked auditory potentials to speech sounds in hearing impaired children
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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:
Hearing Impairment
4842
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Condition category
Condition code
Ear
237185
237185
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0
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Deafness
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
236622
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Not applicable
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Comparator / control treatment
no control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
238003
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Timepoint [1]
238003
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This will be measured at the time of the research appointment, immediately prior to the measurement of the cortical evoked potentials (CAEPs)
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Secondary outcome [1]
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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
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Assessment method [1]
242268
0
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Timepoint [1]
242268
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the speech-evoked cortical auditory evoked potentials (CAEP) will be measured at the time of the research appointment
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Eligibility
Key inclusion criteria
Hearing loss
English speaking
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Minimum age
3
Months
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Maximum age
15
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2009
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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]
1802
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New Zealand
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State/province [1]
1802
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Funding & Sponsors
Funding source category [1]
5005
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University
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Name [1]
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University of Auckland
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Address [1]
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261 Morrin Road,
Glen Innes
Auckland 1072
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Country [1]
5005
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New Zealand
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Primary sponsor type
University
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Name
university of auckland
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Address
261 Morrin Road,
Glen Innes
Auckland 1072
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Country
New Zealand
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Auckland Distract Health Board (ADHB) Audiology
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Address [1]
4525
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ADHB Audiology
Green Lane Clinical Centre
One Tree Hill
Auckland 1051
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Country [1]
4525
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
7106
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Ethics committee address [1]
7106
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Ethics committee country [1]
7106
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Date submitted for ethics approval [1]
7106
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09/06/2009
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Approval date [1]
7106
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Ethics approval number [1]
7106
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Summary
Brief summary
Research has shown that cortical auditory evoked potentials (CAEPs) can be used to objectively verify neural processing of speech sounds and to show that hearing aids provide speech detection in very young infants who cannot be tested using behavioural or observational methods. It is not possible to determine by simple observation whether a young infant who is deaf or hearing impaired is successfully processing speech sounds and hence an objective method to determine both detection and discrimination is required. The aim of the study is to determine whether changes in spectral and temporal characteristics of speech sounds, as measured using a probe microphone at the eardrum, are reflected in the CAEP characteristics measured from scalp surface electrodes. If CAEPs are sensitive to speech changes, this technique can be used as an objective indicator of speech discrimination. This technique has potential for early detection of auditory processing disorder, as well as hearing aid evaluation in young infants found to have a hearing loss as a result of newborn hearing screening.
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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
29637
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Country
29637
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Phone
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Fax
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Email
29637
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Contact person for public queries
Name
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Genevieve Mercer
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Address
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26 Claremont St
Grafton
Auckland 1023
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Country
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New Zealand
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Phone
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+64 27 634 0438
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Fax
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Email
12884
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[email protected]
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Contact person for scientific queries
Name
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Genevieve Mercer
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Address
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26 Claremont St
Grafton
Auckland 1023
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Country
3812
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New Zealand
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Phone
3812
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+64 27 634 0438
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Fax
3812
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Email
3812
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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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