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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06100393




Registration number
NCT06100393
Ethics application status
Date submitted
2/10/2023
Date registered
25/10/2023

Titles & IDs
Public title
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
Scientific title
A Feasibility, Prospective, Repeated-measures Investigation of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients: a Master Umbrella Investigation
Secondary ID [1] 0 0
AI5842
Universal Trial Number (UTN)
Trial acronym
PRESENCE-MU
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Investigational Pre-Processing Algorithm (Sub A)
Treatment: Devices - Cochlear Limited standard-of-care pre-processing algorithms
Treatment: Devices - Investigational Pre-Processing Algorithm (Sub B)

Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A) -

Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B) - Using Spatial Automation Profile


Treatment: Devices: Investigational Pre-Processing Algorithm (Sub A)
The algorithms act upon the digital audio signal received by the microphones and other sensors to enhance speech and attenuate noise prior to encoding the signal for delivery to a cochlear implant via the specified system.

Treatment: Devices: Cochlear Limited standard-of-care pre-processing algorithms
Automatic Gain Control, SNR-NR, Forward Focus

Treatment: Devices: Investigational Pre-Processing Algorithm (Sub B)
Spatial Automation profile
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Australian Sentence Test in Noise (AuSTIN)
Assessment method [1] 0 0
To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores. Scoring: AuSTIN is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence. Range: -30dB to +30dB. Lower scores reflect a better outcome.
Timepoint [1] 0 0
1 day - Immediately post-screening

Eligibility
Key inclusion criteria
* User of an approved Nucleus cochlear implant.
* User of the ACE (Advanced Combination Encoder) sound processing strategy.
* Aged 18 years or older (no upper age limit).
* Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.*
* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* Willing and able to provide written informed consent.
* =3 months post cochlear implant activation
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 the investigator's 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).

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Not applicable
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
22/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Cochlear Melbourne - Melbourne
Recruitment hospital [2] 0 0
HEARnet Clinical Studies - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
3053 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 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 391236633
Email 0 0
limcdonald@cochlear.com
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/NCT06100393