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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

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
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
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
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05270876