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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05866770
Registration number
NCT05866770
Ethics application status
Date submitted
10/05/2023
Date registered
19/05/2023
Date last updated
4/10/2023
Titles & IDs
Public title
A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
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Scientific title
A Feasibility, Prospective, Multi-centre, Repeated Measures Investigation Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
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Secondary ID [1]
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AI5837
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Universal Trial Number (UTN)
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Trial acronym
HATSI-MB
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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 - U8
Treatment: Devices - N8 sound processor
Other: U8 then N8 - Participants in this arm receive U8 followed by N8
Other: N8 then U8 - Participants in this arm receive N8 followed by U8
Treatment: Devices: U8
The U8 Research System
Treatment: Devices: N8 sound processor
Nucleus 8 sound processor
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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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Percent correct monosyllabic word scores.
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Assessment method [1]
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To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level)
Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
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Timepoint [1]
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3 months
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Primary outcome [2]
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Adaptive sentence in noise scores (AuSTIN)
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Assessment method [2]
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To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.
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Timepoint [2]
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3 months
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Eligibility
Key inclusion criteria
- Eighteen years of age or older
- User of CI600, CI500 or CI24RE implant
- At least 3 months experience with a TGA approved Nucleus cochlear implant in at least
one ear
- Fluent speaker of English
- A word speech recognition score of 20% or more when using the cochlear implant alone*
- Willing and able to provide written informed consent *This can be based on clinical
data if collected within the last 12 months
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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
Exclusion criteria:
- 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.
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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
Crossover
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Other design features
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Phase
Not Applicable
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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
11/09/2023
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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
30/06/2026
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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)
MelbourneNSW,VIC
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Recruitment hospital [1]
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Cochlear Melbourne - Melbourne E.
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Recruitment hospital [2]
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Cochlear Macquarie - Sydney
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Recruitment hospital [3]
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HEARnet Clinical Studies - Carlton
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Recruitment postcode(s) [1]
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3002 - Melbourne E.
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Recruitment postcode(s) [2]
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2113 - Sydney
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Recruitment postcode(s) [3]
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3053 - Carlton
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Avania
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
A feasibility, prospective, multi-centre, repeated measures investigation evaluating the
application of hearing aid technologies to signal processing for adult cochlear implant
recipients
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05866770
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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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Komal Arora
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Address
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Country
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Phone
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+61 432 218 588
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05866770
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