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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04898673
Registration number
NCT04898673
Ethics application status
Date submitted
17/05/2021
Date registered
24/05/2021
Date last updated
1/04/2022
Titles & IDs
Public title
CP1110 Sound Processor Feasibility
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Scientific title
A Pre-Marketing, Prospective, Multi-Site, Open-Label, Within-Subject, Feasibility, Interventional Study of Speech Perception With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor and Compared With the CP1000 Sound Processor
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Secondary ID [1]
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CLTD5804
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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:
Adult Cochlear Implant Recipients
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - CP1110
Treatment: Devices - CP1000
Experimental: CP1110 Sound Processor -
Active Comparator: CP1000 Sound Processor. -
Treatment: Devices: CP1110
Sound Processor
Treatment: Devices: CP1000
Sound Processor
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The primary efficacy measure for the CP1110 Sound Processor will be Speech Reception Thresholds (SRT) assessed via sentence scores in spatially separated adaptive noise
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Assessment method [1]
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Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled.
The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome.
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Timepoint [1]
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One day
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Secondary outcome [1]
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Secondary efficacy measures will be the percentage words correct as assessed by CNC (Consonant Nucleus Consonant) Monosyllabic word scores in quiet.
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Assessment method [1]
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Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure.
Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
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Timepoint [1]
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One day
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Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512,
CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422)
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
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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?
Yes
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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 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 in another interventional clinical
study/trial in the past 30 days, or (if less than 30 days) the prior investigation was
Cochlear sponsored and determined by the investigator to not impact clinical findings
of this investigation.
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/10/2021
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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
16/12/2021
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Cochlear Sydney - Sydney
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Recruitment postcode(s) [1]
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2109 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cochlear
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Avania
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The clinical study aims to investigate the speech performance with the CP1110 Sound
Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction
feature in the Automatic Scene Classifier..
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04898673
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04898673
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