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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
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
Secondary ID [1] 0 0
CLTD5818
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Impairment, Sensorineural 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Speech perception in quiet using an OTE Sound Processor
Timepoint [1] 0 0
One day
Secondary outcome [1] 0 0
Speech perception in quiet using an OTE Sound Processor using FF combined with standard microphone directionality
Timepoint [1] 0 0
One day
Secondary outcome [2] 0 0
Speech perception in quiet with CP1150 and CP1110 Sound Processors
Timepoint [2] 0 0
One day

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
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. 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).

Study design
Purpose of the study
Other
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2022
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cochlear Sydney - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Avania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05286385
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries