Back to resultsOptimisation of Hybrid Fittings for Cochlear Implant Recipients
Primary Purpose
Hearing Loss
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Hybrid fittings for cochlear implant recipients
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Cochlear implants, Hybrid fittings, Cross-over frequency
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 years of age)
- Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
- Implanted with the CI500 or CI24RE-series cochlear implants
- User of the commercially available Nucleus 6 sound processor
- User of the ACE strategy
- Native speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
Exclusion Criteria:
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Sites / Locations
- The HEARing CRC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cochlear Implant Recipients
Arm Description
Newly implanted cochlear implant recipients with post-implantation acoustic hearing.
Outcomes
Primary Outcome Measures
Speech, Spatial and Qualities of Hearing (SSQ) scale
Preference rating assessed using SSQ scale
Word recognition scores in quiet
Open-set monosyllabic word scores in quiet
Speech recognition in noise
Open-set speech recognition in noise
Secondary Outcome Measures
Full Information
NCT ID
NCT02765386
First Posted
April 14, 2016
Last Updated
July 2, 2021
Sponsor
The Hearing Cooperative Research Centre
Collaborators
Royal Victoria Eye and Ear Hospital, Cochlear, University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT02765386
Brief Title
Optimisation of Hybrid Fittings for Cochlear Implant Recipients
Official Title
Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
After several years of trying to recruit participants, it was decided to stop the study after recruiting only 12 participants.
Study Start Date
October 7, 2015 (Actual)
Primary Completion Date
September 19, 2018 (Actual)
Study Completion Date
May 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hearing Cooperative Research Centre
Collaborators
Royal Victoria Eye and Ear Hospital, Cochlear, University of Melbourne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.
This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Cochlear implants, Hybrid fittings, Cross-over frequency
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
Cochlear Implant Recipients
Arm Type
Experimental
Arm Description
Newly implanted cochlear implant recipients with post-implantation acoustic hearing.
Intervention Type
Device
Intervention Name(s)
Hybrid fittings for cochlear implant recipients
Primary Outcome Measure Information:
Title
Speech, Spatial and Qualities of Hearing (SSQ) scale
Description
Preference rating assessed using SSQ scale
Time Frame
Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
Title
Word recognition scores in quiet
Description
Open-set monosyllabic word scores in quiet
Time Frame
Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Title
Speech recognition in noise
Description
Open-set speech recognition in noise
Time Frame
Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (≥18 years of age)
Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
Implanted with the CI500 or CI24RE-series cochlear implants
User of the commercially available Nucleus 6 sound processor
User of the ACE strategy
Native speaker in the language used to assess speech perception performance
Willingness to participate in and to comply with all requirements of the protocol
Exclusion Criteria:
Additional handicaps that would prevent participation in evaluations
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Facility Information:
Facility Name
The HEARing CRC
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimisation of Hybrid Fittings for Cochlear Implant Recipients
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