Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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14 March 2022 |
Main ID: |
ACTRN12615000170527 |
Date of registration:
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20/02/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Speech Discrimination and Early Acquisition of Language in Infants with Hearing Loss
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Scientific title:
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Investigating the relationship between early auditory speech discrimination and later language skills in infants with hearing loss |
Date of first enrolment:
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10/08/2015 |
Target sample size:
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150 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12615000170527.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Vicky Zhang
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Address:
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National Acoustic Laboratories
Australian Hearing Hub
Level 5, 16 University Avenue,
Macquarie University,
Ryde, NSW 2109
Australia |
Telephone:
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+612 9412 6735 |
Email:
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vicky.zhang@nal.gov.au |
Affiliation:
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Name:
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Prof Teresa Ching
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Address:
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NextSense Institute, aff with Macquarie University, 361-365 North Rocks Road, North Rocks, NSW 2151, AU
Australia |
Telephone:
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+612 9412 6832 |
Email:
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teresayching@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Participants will be infants: (1) below 12 months of age, (2) detected with bilateral hearing loss, and (3) to be fitted with hearing aids or been fitted with hearing aids in the previous 3 months.
Exclusion criteria: The exclusion criteria are (1) parent indication that the family does not wish to be contacted for research purposes, (2) presence of any diagnosed disabilities in addition to hearing loss, (3) parents who are not willing to travel to the Australian Hearing Hub (in NSW) or Melbourne University (in VIC) for testing, and (4) children who use a cochlear implant.
Age minimum:
1 Months
Age maximum:
12 Months
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Hearing Loss; Hearing Loss
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Ear - Deafness
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Public Health - Health service research
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Intervention(s)
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Children with bilateral hearing loss, between ages 3 to 12 months in NSW and VIC, will be recruited through the national hearing service provider, Australian Hearing. Children will complete: 1) objective (cortical auditory evoked potentials in response to sound changes) assessment of speech discrimination at 6-8 weeks post hearing-aid fitting, and 2) objective and behavioural (head/eye movements in response to sound changes) assessments of speech discrimination at 7-12 months of age. They will return at chronological age of 3 years for repeat assessments of speech discrimination and additionally tests of their speech and language ability. In addition, data will be collected on the child's auditory behaviour in everyday life and family demographics from parent questionnaires. We also include a normative, comparison group of typically hearing infants who will complete the same assessments as the children with hearing loss. The findings will lead to novel clinical tools for assessing auditory discrimination in infants, early referral for cochlear implantation if necessary, and new evidence-based clinical guidelines for best practice management of children with hearing loss.
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Primary Outcome(s)
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Objective auditory discrimination - recording of cortical responses (i.e. auditory evoked potentials) to speech sound contrasts.[Evaluations will be made at three timepoints: within 3 months of initial fitting of hearing aids; and again at chronological ages of 12 months and 3 years. ]
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Speech and language ability - standardised tests of expressive and receptive language that involve direct administration and parent reports will be used. [Evaluations of speech and language ability will be made at chronological age of 3 years.]
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Behavioural auditory discrimination - recording of correct behavioural responses (i.e. head/eye movements) to changes in speech sound contrasts.[Evaluations will be made at two timepoints: 3 months after a child is fitted with hearing aids; and then again at chronological age of 3 years.]
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Secondary Outcome(s)
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Written parent questionnaires - The Parent’s evaluation of Aural/oral performance of children (PEACH) and a questionnaire on demographic details relating to parental education level, language and communication mode at home, and the child’s age at enrolment in early education (if applicable).[Evaluations will be made at two timepoints: 3 months after a child is fitted with hearing aids; and then again at chronological age of 3 years.]
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Source(s) of Monetary Support
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NHMRC
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Ethics review
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Status: Approved
Approval date: 22/01/2015
Contact:
Australian Hearing Human Research Ethics Committee (EC00109)
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Results
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Results available:
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Yes |
Date Posted:
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14/01/2019 |
Date Completed:
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03/02/2021 |
URL:
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