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Trial registered on ANZCTR


Registration number
ACTRN12621000482864
Ethics application status
Approved
Date submitted
4/02/2021
Date registered
23/04/2021
Date last updated
27/06/2022
Date data sharing statement initially provided
23/04/2021
Date results information initially provided
5/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing usability of Nucleus 7 Series Sound Processors when used by adult cochlear implant recipients.
Scientific title
A Pivotal, Pre-Market, Prospective, Single-Site, Open-Label, Within-Subject Repeated Measures, Interventional Study of User Acceptance and Speech Perception with the Nucleus 7 Series Sound Processors when used by adult cochlear implant recipients
Secondary ID [1] 302831 0
CLTD5786
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sensorineural Hearing Loss 319800 0
Condition category
Condition code
Ear 317727 317727 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Nucleus 7 Series comprises of three external behind-the-ear worn processors (CP1000, CP1001, CP1002). The CP1000 sound processor is commercially available but will be loaded with investigational firmware for this study. Speech perception performance testing will be performed using these and comparator sound processors. All speech perception tests will be conducted in sound booths at the site. As subjects are existing Cochlear Implant recipients, explicit training or instructions will not be required. Practice runs for speech testing will be performed for participants to familiarise themselves with the testing procedures. Participants will be asked to listen to specific volumes with and without background noise. Participants will not leave the site with the CP1001, CP1002 or comparator sound processors. Participants will be asked to use the investigational processors for speech testing during 2 visits at the site, with each visit expected to be approximately 1.5-2 hours in duration. Participants test all devices on both visits. Investigational firmware will be loaded on to their own CP1000 processor for take home use. This sound processor is commercially available, however, participants to report any feedback or issues while using the investigational firmware. The investigational firmware does not impact sound quality and is not expected to impact their daily activities and will be removed at their final visit by reverting to commercially available firmware. All study related procedures will be performed by qualified research audiologists. There are no strategies needed to monitor adherence to the intervention as the research audiologist will conduct all speech performance testing with each participant. Data analytics can be accessed in Custom Sound Pro software should the investigator wish to note how many hours the investigational firmware was used during participants at-home use.

Visits 1 and 2 will be at least 1 week apart. All participants will test all investigational devices and comparators during in-booth speech perception testing. To control for order effects, counterbalancing of the test order will be implemented for the primary and secondary speech perception endpoints. All permutations will be represented evenly across the subjects where possible.

The same group of participants will be asked to test the comparator devices.
Intervention code [1] 319299 0
Treatment: Devices
Comparator / control treatment
Comparator devices are included in the study for the purpose of in-booth speech perception testing only. The CP802 and CP910/920 devices are commercially available, and participants will be asked to listen with these processors only during speech perception testing. As such, no additional training or instructions are required. Participants will have at least 5 minutes of general listening time with these devices before formal speech testing is performed. All participants will test each type of control processor during speech performance testing over 2 visits.
Control group
Active

Outcomes
Primary outcome [1] 326001 0
Difference in signal-to-noise (SNR) ratio between CP1002 and CP1001 sound measured using the Australian Speech Test In Noise (AUSTIN).
Timepoint [1] 326001 0
Assessed at Visit 1

Primary outcome [2] 326002 0
The outcome being assessed is the difference in signal-to-noise (SNR) ratio between CP1002 and CP1001 sound processors as tested with their respective noise reduction features enabled.. The goal of the speech perception test in noise is to provide the SNR for 50% speech intelligibility.

Speech perception in noise will be measured using the Australian Speech Test In Noise (AUSTIN) (Dawson, Hersbach, & Swanson, 2013). All sentence in noise tests will be measured using this procedure.
Timepoint [2] 326002 0
Assessed at Visit 2

Secondary outcome [1] 389826 0
Paired difference in percentage consonant-nucleus-consonant (CNC) Words correct in quiet with the CP1001 and CP1000 Sound processors
Timepoint [1] 389826 0
Assessed at Visit 2
Secondary outcome [2] 389829 0
Paired difference in percentage CNC Words quiet
correct with the CP1002 and CP1001 Sound
processors
Timepoint [2] 389829 0
Assessed at Visit 2
Secondary outcome [3] 389830 0
Difference in signal-to-noise (SNR) ratio between CP1002 and CP1001 sound measured using the Australian Speech Test In Noise (AUSTIN) with noise coming from 3 speakers.
Timepoint [3] 389830 0
Assessed at Visit 2

Eligibility
Key inclusion criteria
1) Aged 18 years or older
2) Post lingually deafened
3) Implanted with the CI500 Series (CI512, CI532, CI522), Freedom
Series (CI24RE(CA), CI24RE(ST), CI422), or N24 Series (CI24R(ST), CI24R(CS), CI24R(CA), CI24M) in at least one ear
4) At least 6 months experience with a cochlear implant.
5) At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor
6) Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
7) Willingness to participate in and to comply with all requirements of the protocol.
8) Fluent speaker in English as determined by the investigator
9) Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
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 the
possible benefits, risks and limitations that are inherent to the procedures.
3) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
4) Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
5) Cochlear employees or employees of Contract Research
Organisations or contractors engaged by Cochlear for the purposes of this investigation.
6) Currently participating, or participated within the last 30 days, in
another interventional clinical investigation/trial involving an
investigational drug or device.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/02/2021
Date of last participant enrolment
Anticipated
Actual
9/04/2021
Date of last data collection
Anticipated
12/05/2021
Actual
17/06/2021
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32256 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 307255 0
Commercial sector/Industry
Name [1] 307255 0
Cochlear Ltd
Country [1] 307255 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Ltd
Address
No 1 University Avenue
Macquarie University, NSW 2109
Country
Australia
Secondary sponsor category [1] 307874 0
None
Name [1] 307874 0
Address [1] 307874 0
Country [1] 307874 0
Other collaborator category [1] 281547 0
Commercial sector/Industry
Name [1] 281547 0
Avania CRO
Address [1] 281547 0
13/76 Reserve Road
Artarmon NSW 2064
Country [1] 281547 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307349 0
Bellberry Ltd
Ethics committee address [1] 307349 0
123 Glen Osmond Road,
Eastwood,
SA 5063
Ethics committee country [1] 307349 0
Australia
Date submitted for ethics approval [1] 307349 0
18/11/2020
Approval date [1] 307349 0
19/01/2021
Ethics approval number [1] 307349 0

Summary
Brief summary
The purpose of the pivotal study is to assess the user acceptance and speech perception with the Nucleus 7 Series Sound Processors but used by adult Cochlear Implant recipients. The study will characterise the speech perception difference for sentences in noise using Australian Speech Test in Noise with BKB target sentences and words in quiet using consonant-nucleus-consontant (CNC) Words for Nucleus 7 Series Sound Processor variants and commercially available sound processors (CP802 and CP910/920).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106926 0
Ms Esti Nel
Address 106926 0

1 University Ave,
Macquarie University,
NSW 2109
Country 106926 0
Australia
Phone 106926 0
+61294286285
Fax 106926 0
Email 106926 0
[email protected]
Contact person for public queries
Name 106927 0
Bernadette Pickering
Address 106927 0

1 University Ave,
Macquarie University,
NSW 2109
Country 106927 0
Australia
Phone 106927 0
+61 2 96115909
Fax 106927 0
Email 106927 0
[email protected]
Contact person for scientific queries
Name 106928 0
Bernadette Pickering
Address 106928 0

1 University Ave,
Macquarie University,
NSW 2109
Australia
Country 106928 0
Australia
Phone 106928 0
+61 2 96115909
Fax 106928 0
Email 106928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data will not be shared for this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 380967-(Uploaded-22-06-2022-17-30-16)-Basic results summary.docx
Plain language summaryNo The Nucleus 7 variants, CP1000, CP1001 and CP1002,... [More Details]

Documents added automatically
No additional documents have been identified.