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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06867380




Registration number
NCT06867380
Ethics application status
Date submitted
4/03/2025
Date registered
25/03/2025

Titles & IDs
Public title
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Scientific title
A Feasibility, Prospective, Repeated-measures Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients: a Master Umbrella Investigation
Secondary ID [1] 0 0
AI5838
Universal Trial Number (UTN)
Trial acronym
SONORA-MU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cochlear Implant Recipients 0 0
Hearing Loss, Cochlear 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Investigational sound coding strategy
Treatment: Devices - Cochlear default sound coding strategy

Experimental: Investigational sound coding strategy/Default sound coding strategy (Sub A) - Tested with investigational and default sound coding strategies


Treatment: Devices: Investigational sound coding strategy
SPARC (Stimulation Place and Rate Coding) sound coding strategies

Treatment: Devices: Cochlear default sound coding strategy
ACE (Advanced Combination Encoder) sound coding strategy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
Timepoint [1] 0 0
0 to 12 weeks

Eligibility
Key inclusion criteria
* Users of an approved Nucleus cochlear implant.
* Aged 18 years or older (no upper age limit).
* Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* 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
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* 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
* 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
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2030
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
HEARnet Clinical studies - Carlton
Recruitment hospital [2] 0 0
Cochlear Melbourne - East Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Linty McDonald
Address 0 0
Country 0 0
Phone 0 0
+61 456552543
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06867380