Back to resultsComparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation (CALOS4)
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Categorical loudness scaling based fitting using the Nexus Research System.
Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older (no upper age limit). Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant. Fluent speaker in the language used to assess speech perception performance, as determined by the investigator. Willingness to participate in and comply with all requirements of the protocol. Willing and able to provide written informed consent Exclusion Criteria: Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire. Subject who will be programmed with an acoustic component in the implanted ear. Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear. Diagnosis of auditory neuropathy. Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues. 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 Organizations or contractors engaged by Cochlear for the purposes of this investigation. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). -
Sites / Locations
- HEARnetRecruiting
- Cochlear SydneyRecruiting
- Medizinische Hochschule Hannover (MHH)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.
Arm Description
Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS
Outcomes
Primary Outcome Measures
Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL
To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. Higher the score better the outcome.
Change in Adaptive sentence in noise scores (S0N0 test setup)
To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP. Adaptive sentence in noise scores (S0N0 test setup) averaged across the sessions at visit 4 and visit 5.
Secondary Outcome Measures
Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings
To determine whether the LT MAP provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the Behavioural MAP.
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item.
The change between LT to Behavioural MAP is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL
To determine whether the LT MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP early post activation.
Adaptive Digit Triplet Test (DTT) in noise scores
To determine whether the LT MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP early post activation. Digit triplets are presented adaptively at different SNRs to estimate a patient's Speech Reception Threshold for 50%-digit triplet identification and expressed as a dB SNR (SNR50). The SRT is determined at the end of the test. A higher SRT means a worse outcome
Full Information
NCT ID
NCT05709223
First Posted
December 1, 2022
Last Updated
July 20, 2023
Sponsor
Cochlear
Collaborators
QbD Clinical, Avania
1. Study Identification
Unique Protocol Identification Number
NCT05709223
Brief Title
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation
Acronym
CALOS4
Official Title
Feasibility, Prospective, Within-subject, Interventional Study Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant in the First 3 Months Post-activation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
QbD Clinical, Avania
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 aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
Detailed Description
Firstly, it aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use. Secondly, it aims to collect data to further refine the new fitting method beyond what is evaluated within this study.
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
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participants are blinded to the order of fitting method. Some participants will use first the Behavioural program followed by the investigational program while the other group will use each of these conditions in the opposite order.
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.
Arm Type
Experimental
Arm Description
Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS
Intervention Type
Device
Intervention Name(s)
Categorical loudness scaling based fitting using the Nexus Research System.
Other Intervention Name(s)
The Nexus Research System.
Intervention Description
The Nexus Research system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate Firmware updates of the system. It is also intended to be used with other devices of a hearing implant system to make volume adjustments to the processing unit, to download pre-defined MAPs and to collect data from tests and questionnaires using a compatible device.
Intervention Type
Device
Intervention Name(s)
Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
Intervention Description
The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software
Primary Outcome Measure Information:
Title
Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL
Description
To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. Higher the score better the outcome.
Time Frame
2 days(In booth testing)
Title
Change in Adaptive sentence in noise scores (S0N0 test setup)
Description
To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP. Adaptive sentence in noise scores (S0N0 test setup) averaged across the sessions at visit 4 and visit 5.
Time Frame
2 days (In booth testing)
Secondary Outcome Measure Information:
Title
Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings
Description
To determine whether the LT MAP provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the Behavioural MAP.
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item.
The change between LT to Behavioural MAP is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Time Frame
4 weeks
Title
Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL
Description
To determine whether the LT MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP early post activation.
Time Frame
One day (in booth testing)
Title
Adaptive Digit Triplet Test (DTT) in noise scores
Description
To determine whether the LT MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP early post activation. Digit triplets are presented adaptively at different SNRs to estimate a patient's Speech Reception Threshold for 50%-digit triplet identification and expressed as a dB SNR (SNR50). The SRT is determined at the end of the test. A higher SRT means a worse outcome
Time Frame
One day (in clinic testing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older (no upper age limit).
Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
Willingness to participate in and comply with all requirements of the protocol.
Willing and able to provide written informed consent
Exclusion Criteria:
Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
Subject who will be programmed with an acoustic component in the implanted ear.
Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
Diagnosis of auditory neuropathy.
Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
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 Organizations or contractors engaged by Cochlear for the purposes of this investigation.
Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anke Plasmans
Phone
+3215795515
Email
APlasmans@cochlear.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Plasmans
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
HEARnet
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Plasmans
Phone
+3215795515
Email
APlasmans@cochlear.com
First Name & Middle Initial & Last Name & Degree
Karyn Galvin, PhD
Facility Name
Cochlear Sydney
City
Sydney
ZIP/Postal Code
2113
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Plasmans
Phone
+3215795515
Email
APlasmans@cochlear.com
First Name & Middle Initial & Last Name & Degree
Saji Maruthurkkara, MSc.
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Plasmans
Phone
+3215795515
Email
APlasmans@cochlear.com
First Name & Middle Initial & Last Name & Degree
Professor Andreas Buechner, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation
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