Back to resultsCHANGE Feasibility Study (CLTD5626)
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Nucleus CI532 cochlear implant
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Cochlear Prosthesis Implantation
Eligibility Criteria
Inclusion Criteria:
- Meet current cochlear implant indications at the implanting centre
- In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted.
- Fluent speaker in the local language used to assess clinical performance
- Eighteen years of age or older at the time of implantation with no upper age limit
Exclusion Criteria:
- Evidence of hearing loss prior to 5 years of age.
- Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
- Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
- Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
- Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
- Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
- Active middle-ear infection,
- Tympanic membrane perforation
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
- Unwillingness or inability of the candidate to comply with all investigational requirements.
- Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
- Patients with recurrent episodes of bacterial meningitis.
Sites / Locations
- The Hearing Cooperative Research Centre
- Royal Victorian Eye and Ear Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implantation with Nucleus CI532 cochlear implant
Arm Description
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Outcomes
Primary Outcome Measures
Report on Degree of Hearing as Measured by Pure Tone Audiogram
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Report on Clinical Performance in Quiet and Noise
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Report of Medical/Surgical and Device Related Adverse Events.
Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
Secondary Outcome Measures
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.
Glasgow Benefit Inventory (GBI).
Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.
Full Information
NCT ID
NCT02671032
First Posted
January 27, 2016
Last Updated
June 8, 2021
Sponsor
Cochlear
Collaborators
The Hearing Cooperative Research Centre, Royal Victoria Eye and Ear Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02671032
Brief Title
CHANGE Feasibility Study
Acronym
CLTD5626
Official Title
Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2016 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
The Hearing Cooperative Research Centre, Royal Victoria Eye and Ear Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Cochlear Prosthesis Implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implantation with Nucleus CI532 cochlear implant
Arm Type
Experimental
Arm Description
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Intervention Type
Device
Intervention Name(s)
Nucleus CI532 cochlear implant
Primary Outcome Measure Information:
Title
Report on Degree of Hearing as Measured by Pure Tone Audiogram
Description
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Time Frame
6 months and 12 months post activation
Title
Report on Clinical Performance in Quiet and Noise
Description
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Time Frame
3 months, 6 months and 12 months post activation
Title
Report of Medical/Surgical and Device Related Adverse Events.
Description
Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
Time Frame
12 months post activation.
Secondary Outcome Measure Information:
Title
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Description
Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.
Time Frame
Preoperative and 6 months post activation
Title
Glasgow Benefit Inventory (GBI).
Description
Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.
Time Frame
6 months post activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet current cochlear implant indications at the implanting centre
In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted.
Fluent speaker in the local language used to assess clinical performance
Eighteen years of age or older at the time of implantation with no upper age limit
Exclusion Criteria:
Evidence of hearing loss prior to 5 years of age.
Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
Active middle-ear infection,
Tympanic membrane perforation
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
Unwillingness or inability of the candidate to comply with all investigational requirements.
Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
Patients with recurrent episodes of bacterial meningitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Cowan, DipAud PhD
Organizational Affiliation
HEARing CRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hearing Cooperative Research Centre
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
30002
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Cochlear do not have an approved platform for sharing IPD. Data may be provided to individual researchers on request.
Learn more about this trial
CHANGE Feasibility Study
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