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Trial registered on ANZCTR
Registration number
ACTRN12619000666123
Ethics application status
Approved
Date submitted
11/04/2019
Date registered
3/05/2019
Date last updated
27/09/2021
Date data sharing statement initially provided
3/05/2019
Date results information initially provided
27/09/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Usability and effectiveness of next generation sound processor used in adult hearing impaired population
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Scientific title
A pre-market, prospective, single-site, open-label, within-subject, interventional study of usability and speech perception with the CP1150 sound processor in the adult hearing impaired population
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Secondary ID [1]
297925
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CLTD5754
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Universal Trial Number (UTN)
U1111-1231-4424
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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:
Post Lingual hearing Loss
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Condition category
Condition code
Ear
310877
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0
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All participants will be fitted with an investigational sound processor (CP1150) for use with 1 or 2 ears by a qualified audiologist. It will take approximately 30 minutes to fit a sound processor (connect to the existing cochlear implant).
The study will run over 3 phases for a total of 9 months. In phase 1, only one ear will be fitted. If the subject has 2 implants, the second will not be used. In phases 2 and 3, if the subject has two compatible implants, then both will be used.
Phase 1 is usability and speech testing conducted on a single day.
Phase 2 includes a 2-4 week take-home period reviewing the usability of the CP1150. Phase 3 includes a 2-4 week take-home period reviewing the usability of the device and speech testing.
There may be up to 4 months between phases; during this time you will not be using the CP1150 sound processor.
Device use will be monitored through questionnaires, diaries, data logs from the sound processor and usability testing scenarios to be completed during periods of at-home use.
A total of 5 clinical visits will be required over the 3 phases. Each clinic visit will take approximately 3 hours. Usability testing is reviewing a list of activities to determine if the subject can complete them. Speech testing is completed in a sound booth. All the procedures are conducted by an investigator who is a trained audiologist.
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Intervention code [1]
314148
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Treatment: Devices
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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]
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Speech Perception (word detection in a noise-controlled environment using AuSTIN adaptive sentences)
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Assessment method [1]
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Timepoint [1]
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Completion of Phase 3
Phase 1 will take 1 day for each subject to complete – all subjects will subjects will proceed to Phase 2 after completion of all subjects. It is estimated that this will take approximately 4 weeks to complete.
Phase 2 will take 4 weeks to complete for each subject – subjects will proceed to Phase 3 after completion of all subjects. It is estimated that this will take approximately 2 months to complete.
Phase 3 will take 4 weeks to complete for each subject – phase 3 will take about 2 months to complete.
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Secondary outcome [1]
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Usability of the CP1150 sound processor and accessories through analysis of usability questionnaire and usability task lists. These questionnaires and task lists are specifically designed for testing the CP1150 sound processor.
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Assessment method [1]
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Timepoint [1]
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Completion of Phases 1 and 2,
Phase 1 will take 1 day for each subject to complete – all subjects will subjects will proceed to Phase 2 after completion of all subjects. It is estimated that this will take approximately 4 weeks to complete.
Phase 2 will take 4 weeks to complete for each subject – subjects will proceed to Phase 3 after completion of all subjects. It is estimated that this will take approximately 2 months to complete.
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Secondary outcome [2]
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Subjective ratings of functional hearing in different environments through analysis of take-home questionnaires and diaries. These questionnaires and diary are specifically designed for testing the CP1150 sound processor.
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Assessment method [2]
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Timepoint [2]
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Completion of Phases 2 and 3
Phase 2 will take 4 weeks to complete for each subject – subjects will proceed to Phase 3 after completion of all subjects. It is estimated that this will take approximately 2 months to complete.
Phase 3 will take 4 weeks to complete for each subject – phase 3 will take about 2 months to complete.
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Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI500 series or Freedom series in at least one ear
4. At least 3 months experience with a cochlear implant
5. Able to complete open set speech perception tests as determined by the investigator
6. Willingness to participate in and to comply with all requirements of the protocol
7. Fluent speaker in the language used to assess speech perception performance as determined by the investigator
8. Willing and able to provide written informed consent
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Minimum age
18
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
1. Additional disabilities that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding possible benefits, risks and limitation that are inherent to the procedures
3. Implant location that would result in undesirable hearing performance or discomfort, as determined by the investigator
4. Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the investigator
5. Investigator site personnel directly affiliated with this this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
6. Cochlear employees or employees of contract research organisations or contractors engaged by Cochlear for the purposes of this investigation
7. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
8. Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
95% confidence interval (alpha=0.025 one-sided) for the mean paired difference will be calculated for the primary endpoint
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/05/2019
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Actual
9/05/2019
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Date of last participant enrolment
Anticipated
1/06/2019
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Actual
25/08/2020
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Date of last data collection
Anticipated
31/01/2020
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Actual
25/08/2020
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Sample size
Target
22
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
26237
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2109 - Macquarie University
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Cochlear Limited
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Address [1]
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1 University Avenue
Macquarie University
NSW 2109
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Cochlear Limited
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Address
1 University Avenue
Macquarie University
NSW 2109
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
302343
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Country [1]
302343
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Limited HREC
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Ethics committee address [1]
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123 Glen Osmond Road
East Adelaide
SA 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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19/03/2019
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Approval date [1]
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23/04/2019
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Ethics approval number [1]
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2019-02-129
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Summary
Brief summary
The experimental sound processor and associated accessories is a sound processor that aims to combine the sound processing, connectivity, comfort and discretion of the behind-the-ear Nucleus 7 sound processor, This study requires usability listing tests in both the clinic and at-home use of the prototype design.
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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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Ms Marian Jones
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Address
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1 University Avenue
Macquarie University
NSW 2109
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Country
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Australia
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Phone
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+61 2 94255269
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Marian Jones
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Address
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1 University Avenue
Macquarie University
NSW 2109
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Country
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Australia
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Phone
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+61 2 94255269
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Marian Jones
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Address
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1 University Avenue
Macquarie University
NSW 2109
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Country
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Australia
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Phone
92512
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+61 2 94255269
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Fax
92512
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Email
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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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