Back to resultsA Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients (FOCUS)
Primary Purpose
Hearing Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Focused stimulation strategy
ACE stimulation strategy
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Impairment focused on measuring cochlear implantation
Eligibility Criteria
Inclusion Criteria:
- Adults 18 years of age or older.
- Candidate for unilateral cochlear implant with Slim Modiolar electrode array as determined by the implanting centre.
- English spoken as a primary language.
- Willingness to comply with all investigational requirements.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Previous or existing cochlear-implant recipient.
- Evidence of severe or greater sensorineural hearing loss prior to five years of age.
- Open-set pre-operative word score > 70% in the contralateral ear.
- Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
- Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component in the implanted ear.
- Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
- Hearing loss of neural or central origin.
- Medical or psychological conditions that would contraindicate undergoing surgery.
- Women who are pregnant.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations.
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
- Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- 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 Organisations 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
- NextSense - DeakinRecruiting
- NextSense - BroadmeadowRecruiting
- Royal Victorian Eye and Ear HospitalRecruiting
- St Vincent's Private HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adults cochlear implant recipients receiving alternative stimulation strategy
Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy.
Arm Description
ACE strategy, 8 maxima, alternative mode
ACE strategy, 8 maxima, monopolar mode.
Outcomes
Primary Outcome Measures
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05003674
Brief Title
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
Acronym
FOCUS
Official Title
A Feasibility, Prospective, Multi-centre, Repeated-measures Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
March 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 feasibility study is designed to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP) stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination.
Detailed Description
Alternative modes of stimulation will be investigated that may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical benefits over MP stimulation. The purpose of this feasibility study is to explore several facets of hearing performance that may show improvements with these alternative modes of stimulation compared to MP stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination. Individual neural, psychophysical, cognitive, and electrode placement data will also be obtained to inform questions related to across-subject variability, and practical aspects of power consumption and device fitting will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment
Keywords
cochlear implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adults cochlear implant recipients receiving alternative stimulation strategy
Arm Type
Experimental
Arm Description
ACE strategy, 8 maxima, alternative mode
Arm Title
Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy.
Arm Type
Active Comparator
Arm Description
ACE strategy, 8 maxima, monopolar mode.
Intervention Type
Device
Intervention Name(s)
Focused stimulation strategy
Intervention Description
Investigational focused stimulation strategy
Intervention Type
Device
Intervention Name(s)
ACE stimulation strategy
Intervention Description
Standard of care stimulation strategy
Primary Outcome Measure Information:
Title
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults 18 years of age or older.
Candidate for unilateral cochlear implant with Slim Modiolar electrode array as determined by the implanting centre.
English spoken as a primary language.
Willingness to comply with all investigational requirements.
Willing and able to provide written informed consent.
Exclusion Criteria:
Previous or existing cochlear-implant recipient.
Evidence of severe or greater sensorineural hearing loss prior to five years of age.
Open-set pre-operative word score > 70% in the contralateral ear.
Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component in the implanted ear.
Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
Hearing loss of neural or central origin.
Medical or psychological conditions that would contraindicate undergoing surgery.
Women who are pregnant.
Additional handicaps that would prevent or restrict participation in the audiological evaluations.
Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
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 Organisations 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
Ruth English
Phone
+61438745639
Email
renglish@cochlear.com
First Name & Middle Initial & Last Name or Official Title & Degree
Herah Hansji
Phone
+13032642575
Email
hhansji@cochlear.com
Facility Information:
Facility Name
NextSense - Deakin
City
Deakin
State/Province
Australian Capital Territory
ZIP/Postal Code
2600
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Makeham, doctor
Phone
0438445383
Email
dmakeham@canberraent.com.au
Facility Name
NextSense - Broadmeadow
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnson Huang, Doctor
Email
drjohnsonhuang.ent@gmail.com
Facility Name
Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Cowan, Professor
Phone
+61 (0)3 9035 5346
Email
rcowan@unimelb.edu.au
Facility Name
St Vincent's Private Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Cowan, Professor
Phone
+61 (0)3 9035 5346
Email
rcowan@unimelb.edu.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
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