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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05709223




Registration number
NCT05709223
Ethics application status
Date submitted
1/12/2022
Date registered
2/02/2023

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
AI5824
Universal Trial Number (UTN)
Trial acronym
CALOS4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Categorical loudness scaling based fitting using the Nexus Research System.
Treatment: Devices - Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

Experimental: Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting. - Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS


Treatment: Devices: Categorical loudness scaling based fitting using the Nexus Research System.
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.

Treatment: Devices: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL
Timepoint [1] 0 0
2 days(In booth testing)
Primary outcome [2] 0 0
Change in Adaptive sentence in noise scores (S0N0 test setup)
Timepoint [2] 0 0
2 days (In booth testing)
Secondary outcome [1] 0 0
Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL
Timepoint [2] 0 0
One day (in booth testing)
Secondary outcome [3] 0 0
Adaptive Digit Triplet Test (DTT) in noise scores
Timepoint [3] 0 0
One day (in clinic testing)

Eligibility
Key inclusion criteria
1. Aged 18 years or older (no upper age limit).
2. Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
3. Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
4. Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
5. Willingness to participate in and comply with all requirements of the protocol.
6. Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
2. Subject who will be programmed with an acoustic component in the implanted ear.
3. 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.
4. Diagnosis of auditory neuropathy.
5. Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
6. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
7. Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling.
8. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
9. 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). -

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
HEARnet - Carlton
Recruitment hospital [2] 0 0
Cochlear Sydney - Sydney
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
2113 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
Germany
State/province [2] 0 0
Hannover

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
QbD Clinical
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Avania
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anke Plasmans
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anke Plasmans
Address 0 0
Country 0 0
Phone 0 0
+3215795515
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05709223