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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04898673




Registration number
NCT04898673
Ethics application status
Date submitted
17/05/2021
Date registered
24/05/2021

Titles & IDs
Public title
CP1110 Sound Processor Feasibility
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
Secondary ID [1] 0 0
CLTD5804
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Cochlear Implant Recipients 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CP1110
Treatment: Devices - CP1000

Experimental: CP1000 Sound Processor followed by the CP1110 Sound Processor - All study subjects were provided with a unique identifier. The ones that ended in an odd number were administered the CP1000 Sound Processor followed by the CP1110 Sound Processor.

Experimental: CP1110 Sound Processor followed by the CP1000 Sound Processor - All study subjects were provided with a unique identifier. The ones that ended in an even number were administered the CP1110 Sound Processor followed by the CP1000 Sound Processor.


Treatment: Devices: CP1110
Sound Processor

Treatment: Devices: CP1000
Sound Processor
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise
Timepoint [1] 0 0
One day
Secondary outcome [1] 0 0
Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
Timepoint [1] 0 0
One day
Secondary outcome [2] 0 0
Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
Timepoint [2] 0 0
One day
Secondary outcome [3] 0 0
Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
Timepoint [3] 0 0
One Day

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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
Crossover
Other design features
Phase
NA
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
25/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/12/2021
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cochlear Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney

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
Trial website
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

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04898673