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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/NCT05286385
Registration number
NCT05286385
Ethics application status
Date submitted
22/02/2022
Date registered
18/03/2022
Date last updated
7/07/2022
Titles & IDs
Public title
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
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Scientific title
A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Pilot, Interventional Study of Adult Cochlear Implant Speech Perception With the CP1150 Sound Processor Compared With the Next Generation of Signal Processing Technology
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Secondary ID [1]
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CLTD5818
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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:
Hearing Impairment, Sensorineural
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - CP1150 Sound Processor
Treatment: Devices - CP1150 (modified firmware)
Treatment: Devices - CP1150 + FF
Treatment: Devices - CP1110
Active Comparator: CP1150 - CP1150 will be used as the comparator device for speech perception testing in quiet.
Experimental: CP1150 (modified firmware) - CP1150 Sound Processor with modified firmware.
Experimental: CP1150 + FF - CP1150 Sound Processor with ForwardFocus.
Experimental: CP1110 - CP1110 is a BTE Sound Processor.
Treatment: Devices: CP1150 Sound Processor
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor
Treatment: Devices: CP1150 (modified firmware)
Speech perception tests whilst the subject is fitted with the CP1150 modified firmware.
Treatment: Devices: CP1150 + FF
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.
Treatment: Devices: CP1110
Speech perception tests whilst the subject is fitted with the CP1110 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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Speech perception in quiet using an OTE Sound Processor
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Assessment method [1]
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Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.
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Timepoint [1]
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One day
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Secondary outcome [1]
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Speech perception in quiet using an OTE Sound Processor using FF combined with standard microphone directionality
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Assessment method [1]
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Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with FF
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Timepoint [1]
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One day
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Secondary outcome [2]
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Speech perception in quiet with CP1150 and CP1110 Sound Processors
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Assessment method [2]
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Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor
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Timepoint [2]
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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, CI500 Series or Freedom Series
4. At least 6 months experience with a cochlear implant.
5. At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound
Processor
6. MAP Total Stimulation Rate of 7.2kHz or greater
7. Able to score 30% or more with CI alone on a monosyllabic words in quiet test
8. Willingness to participate in and to comply with all requirements of the protocol
9. Fluent speaker in English as determined by the investigator
10. 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. Implant location that would result in undesirable hearing performance or discomfort
with an off-the-ear sound processor, as determined by the investigator.
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 unless (if less than 30 days) the prior investigation was Cochlear
sponsored and determined by the investigator to not impact clinical findings of this
investigation.
7. Implanted with other active implantable medical devices (e.g. pacemaker,
defibrillator).
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Study design
Purpose of the study
Other
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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
Crossover
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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
30/05/2022
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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
29/06/2022
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Cochlear Sydney - Macquarie Park
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Recruitment postcode(s) [1]
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2109 - Macquarie Park
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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
This clinical study aims to investigate speech performance in quiet with an OTE Sound
Processor with modified firmware compared with the commercially available CP1150. The study
also investigates CP1110 and CP1150 with Forward Focus.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05286385
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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
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Address
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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/NCT05286385
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