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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
3/05/2019
Date data sharing statement initially provided
3/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Usability and effectiveness of next generation sound processor used in adult hearing impaired population
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
Secondary ID [1] 297925 0
CLTD5754
Universal Trial Number (UTN)
U1111-1231-4424
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Lingual hearing Loss 312313 0
Condition category
Condition code
Ear 310877 310877 0 0
Deafness

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314148 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319696 0
Speech Perception (word detection in a noise-controlled environment using AuSTIN adaptive sentences)
Timepoint [1] 319696 0
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.
Secondary outcome [1] 369207 0
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.
Timepoint [1] 369207 0
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.
Secondary outcome [2] 369208 0
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.
Timepoint [2] 369208 0
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.

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
95% confidence interval (alpha=0.025 one-sided) for the mean paired difference will be calculated for the primary endpoint

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 26237 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 302441 0
Commercial sector/Industry
Name [1] 302441 0
Cochlear Limited
Address [1] 302441 0
1 University Avenue
Macquarie University
NSW 2109
Country [1] 302441 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Limited
Address
1 University Avenue
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 302343 0
None
Name [1] 302343 0
Address [1] 302343 0
Country [1] 302343 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303110 0
Bellberry Limited HREC
Ethics committee address [1] 303110 0
123 Glen Osmond Road
East Adelaide
SA 5063
Ethics committee country [1] 303110 0
Australia
Date submitted for ethics approval [1] 303110 0
19/03/2019
Approval date [1] 303110 0
23/04/2019
Ethics approval number [1] 303110 0
2019-02-129

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92510 0
Ms Marian Jones
Address 92510 0
1 University Avenue
Macquarie University
NSW 2109
Country 92510 0
Australia
Phone 92510 0
+61 2 94255269
Fax 92510 0
Email 92510 0
mjones@cochlear.com
Contact person for public queries
Name 92511 0
Ms Marian Jones
Address 92511 0
1 University Avenue
Macquarie University
NSW 2109
Country 92511 0
Australia
Phone 92511 0
+61 2 94255269
Fax 92511 0
Email 92511 0
mjones@cochlear.com
Contact person for scientific queries
Name 92512 0
Ms Marian Jones
Address 92512 0
1 University Avenue
Macquarie University
NSW 2109
Country 92512 0
Australia
Phone 92512 0
+61 2 94255269
Fax 92512 0
Email 92512 0
mjones@cochlear.com

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 other documents available
Summary results
No Results