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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.
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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
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Secondary ID [1]
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AI5842
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Universal Trial Number (UTN)
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Trial acronym
PRESENCE-MU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Australian Sentence Test in Noise (AuSTIN)
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Assessment method [1]
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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.
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Timepoint [1]
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1 day - Immediately post-screening
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Cochlear Melbourne - Melbourne
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Recruitment hospital [2]
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HEARnet Clinical Studies - Melbourne
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Recruitment postcode(s) [1]
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3002 - Melbourne
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Recruitment postcode(s) [2]
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3053 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cochlear
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Master Umbrella Clinical Investigation will be comprised of several sub-investigations, which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.
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Trial website
https://clinicaltrials.gov/study/NCT06100393
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Linty McDonald
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Address
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Country
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Phone
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+61 391236633
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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