Back to resultsInnovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
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).
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.
Sites / Locations
- HEARnet Clinical Studies - The University of Melbourne
- Cochlear Ltd. Melbourne
- AZ Sint-Jan Brugge-Oostende AVRecruiting
- Sint-Augustinus AntwerpenRecruiting
- Cochlear Technology Centre Belgium
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational
Standard of Care
Arm Description
Recipients of cochlear implant or suitable for implantation
Recipients of cochlear implant or suitable for implantation
Outcomes
Primary Outcome Measures
Mean difference between standard and novel fitting method for monosyllabic word scores in quiet
Percent correct word scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05270876
Brief Title
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational
Arm Type
Experimental
Arm Description
Recipients of cochlear implant or suitable for implantation
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Recipients of cochlear implant or suitable for implantation
Intervention Type
Device
Intervention Name(s)
Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor
Intervention Description
The comparator will be the standard of care fitting or diagnostic or measurement approach.
Primary Outcome Measure Information:
Title
Mean difference between standard and novel fitting method for monosyllabic word scores in quiet
Description
Percent correct word scores
Time Frame
0 to 4 weeks after fitting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taike Bruyneel
Phone
003215795564
Email
tbruyneel@cochlear.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anke Plasmans
Phone
003215795511
Email
aplasmans@cochlear.com
Facility Information:
Facility Name
HEARnet Clinical Studies - The University of Melbourne
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Cowan
Phone
+61 3 9035 5346
Email
r.cowan@unimelb.edu.au
Facility Name
Cochlear Ltd. Melbourne
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
State/Province
België
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bob Lerut, Medical Doctor
Phone
003250452280
Email
bob.lerut@azsintjan.be
Facility Name
Sint-Augustinus Antwerpen
City
Wilrijk
State/Province
België
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrzej Zarowski
Phone
003234433604
Email
Andrzej.zarowski@gza.be
Facility Name
Cochlear Technology Centre Belgium
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
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