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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05270876




Registration number
NCT05270876
Ethics application status
Date submitted
28/09/2021
Date registered
8/03/2022
Date last updated
22/02/2024

Titles & IDs
Public title
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
Scientific title
A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation
Secondary ID [1] 0 0
AI5763
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
Treatment: Devices - Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor

Experimental: Investigational - Recipients of cochlear implant or suitable for implantation

Active comparator: Standard of Care - Recipients of cochlear implant or suitable for implantation


Treatment: Devices: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
Experimental: The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.

Treatment: Devices: Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor
The comparator will be the standard of care fitting or diagnostic or measurement approach.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean difference between standard and novel fitting method for monosyllabic word scores in quiet
Timepoint [1] 0 0
0 to 4 weeks after fitting

Eligibility
Key inclusion criteria
* Group 1 subjects: Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding or Group 2 subjects: Subjects assessed by their CI clinic to be suitable for implantation with a commercially available CE approved Nucleus cochlear implant.
* Paediatrics: Older than 10 months and <18 years when entering the study (Belgium only) or Adults: =18 years when entering the study (Belgium and Australia)
* Subject/legally designated representative is fluent speaker in the language used for assessments.
* Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/legally designated representative).
Minimum age
10 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
* 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
Other
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
19/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2023
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
HEARnet Clinical Studies - The University of Melbourne - Carlton
Recruitment hospital [2] 0 0
Cochlear Ltd. Melbourne - East Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Carlton
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
België
Country [2] 0 0
Belgium
State/province [2] 0 0
Mechelen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.
Trial website
https://clinicaltrials.gov/study/NCT05270876
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05270876