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Trial registered on ANZCTR
Registration number
ACTRN12619000131156
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
30/01/2019
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Feasibility of intra-operative cochlear health monitoring to predict hearing preservation in cochlear implant recipients.
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Scientific title
Feasibility of intra-operative cochlear health monitoring to predict hearing preservation in cochlear implant recipients.
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Secondary ID [1]
296925
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None
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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 Loss
310876
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Condition category
Condition code
Ear
309551
309551
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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
False
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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
The loss of all natural hearing can occur immediately after cochlear implantation. In this study, the electrical response of the cochlea to acoustic tones will be measured 14 times per second during cochlear implantation (Intra-operative electrocochleography). This response will be monitored for sudden reductions in cochlear output, suggesting a reduction in hearing function. The electrical response will be monitored for the duration of the implantation, typically 5-10 minutes for a total surgical observation time of 3 hours. Audiometric hearing thresholds will be measure pre-operatively and 3-months post-surgery for sessions of 30 minutes each. Total observation time per patient is approximately 4 hours.
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Intervention code [1]
313196
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Not applicable
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Comparator / control treatment
no control Group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
318499
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Hearing level at 500-Hz, assessed by pure tone audiometry measured by a qualified audiologist pre-operatively, and again 3 months after surgery.
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Assessment method [1]
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Timepoint [1]
318499
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3 months
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Secondary outcome [1]
365169
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Hearing level at 500-Hz, assessed by pure tone audiometry measured by a qualified audiologist pre-operatively, and again 12 months after surgery.
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Assessment method [1]
365169
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Timepoint [1]
365169
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12 months
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Eligibility
Key inclusion criteria
Any child or adult capable of participating with an audiogram, in whom a clinical recommendation has been made to receive a cochlear implant.
Receiving a slim-straight Cochlear CI522 electrode array.
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Minimum age
1
Years
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Maximum age
No limit
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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
Deafness due to cochlear malformations, including ossification, confirmed by medical examination
Pre-existing cochlear implantation
Any medical or psychological conditions inappropriate for general anaesthesia or surgery
Any condition contraindicating cochlear implantation under current surgical guidelines
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
Non parametric comparison of median hearing loss
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
20/02/2015
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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
150
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Accrual to date
127
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
301499
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Commercial sector/Industry
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Name [1]
301499
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COCHLEAR LTD
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Address [1]
301499
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174 Victoria PArade East melbourne Victoria 3002
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Country [1]
301499
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
Level 5, Peter Howsen Building , 32 Gisborne Street, East Melbourne, 3002 Victoria
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Country
Australia
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Secondary sponsor category [1]
301192
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None
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Name [1]
301192
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none
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Address [1]
301192
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None
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Country [1]
301192
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302240
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The Royal Victorian Eye & Ear Hospital Human Research & Ethics Committee
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Ethics committee address [1]
302240
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32 Gisborne Street,East Melbourne, 3002 Victoria
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Ethics committee country [1]
302240
0
Australia
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Date submitted for ethics approval [1]
302240
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Approval date [1]
302240
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27/02/2014
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Ethics approval number [1]
302240
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Summary
Brief summary
A significant proportion of cochlear implant recipients lose all residual, natural hearing immediately after the surgery. The aim of this trial is to test the use of electrocochleography measured during implantation to estimate cochlear health, to predict the preservation of residual hearing.
Patients will be followed up for 12 months after surgery.
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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
89554
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Prof Stephen O'Leary
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Address
89554
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University of Melbourne, Department of Otolaryngology
Level 5
Peter Howsen Building
Gisborne Street
East Melbourne
3002
Victoria
Australia
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Country
89554
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Australia
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Phone
89554
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+61 399298366
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Fax
89554
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Email
89554
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[email protected]
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Contact person for public queries
Name
89555
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Dr Christo Bester
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Address
89555
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University of Melbourne, Department of Otolaryngology
Level 5
Peter Howsen Building
Gisborne Street
East Melbourne
3002
Victoria
Australia
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Country
89555
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Australia
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Phone
89555
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+61 399298485
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Fax
89555
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Email
89555
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[email protected]
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Contact person for scientific queries
Name
89556
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Dr Christo Bester
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Address
89556
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University of Melbourne, Department of Otolaryngology
Level 5
Peter Howsen Building
Gisborne Street
East Melbourne
3002
Victoria
Australia
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Country
89556
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Australia
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Phone
89556
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+61 399298485
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Fax
89556
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Email
89556
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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