Trial Review

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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.
Scientific title
Feasibility of intra-operative cochlear health monitoring to predict hearing preservation in cochlear implant recipients.
Secondary ID [1] 296925 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 310876 0
Condition category
Condition code
Ear 309551 309551 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 313196 0
Not applicable
Comparator / control treatment
no control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318499 0
Hearing level at 500-Hz, assessed by pure tone audiometry measured by a qualified audiologist pre-operatively, and again 3 months after surgery.
Timepoint [1] 318499 0
3 months
Secondary outcome [1] 365169 0
Hearing level at 500-Hz, assessed by pure tone audiometry measured by a qualified audiologist pre-operatively, and again 12 months after surgery.
Timepoint [1] 365169 0
12 months

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.
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Non parametric comparison of median hearing loss

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
127
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301499 0
Commercial sector/Industry
Name [1] 301499 0
COCHLEAR LTD
Country [1] 301499 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Level 5, Peter Howsen Building , 32 Gisborne Street, East Melbourne, 3002 Victoria
Country
Australia
Secondary sponsor category [1] 301192 0
None
Name [1] 301192 0
none
Address [1] 301192 0
None
Country [1] 301192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302240 0
The Royal Victorian Eye & Ear Hospital Human Research & Ethics Committee
Ethics committee address [1] 302240 0
32 Gisborne Street,East Melbourne, 3002 Victoria
Ethics committee country [1] 302240 0
Australia
Date submitted for ethics approval [1] 302240 0
Approval date [1] 302240 0
27/02/2014
Ethics approval number [1] 302240 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89554 0
Prof Stephen O'Leary
Address 89554 0
University of Melbourne, Department of Otolaryngology
Level 5
Peter Howsen Building
Gisborne Street
East Melbourne
3002
Victoria
Australia
Country 89554 0
Australia
Phone 89554 0
+61 399298366
Fax 89554 0
Email 89554 0
sjoleary@unimelb.edu.au
Contact person for public queries
Name 89555 0
Dr Christo Bester
Address 89555 0
University of Melbourne, Department of Otolaryngology
Level 5
Peter Howsen Building
Gisborne Street
East Melbourne
3002
Victoria
Australia
Country 89555 0
Australia
Phone 89555 0
+61 399298485
Fax 89555 0
Email 89555 0
christofer.bester@unimelb.edu.au
Contact person for scientific queries
Name 89556 0
Dr Christo Bester
Address 89556 0
University of Melbourne, Department of Otolaryngology
Level 5
Peter Howsen Building
Gisborne Street
East Melbourne
3002
Victoria
Australia
Country 89556 0
Australia
Phone 89556 0
+61 399298485
Fax 89556 0
Email 89556 0
christofer.bester@unimelb.edu.au

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.