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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/NCT06098482
Registration number
NCT06098482
Ethics application status
Date submitted
19/10/2023
Date registered
24/10/2023
Date last updated
22/03/2024
Titles & IDs
Public title
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
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Scientific title
A Prospective, Repeated-measures Investigation to Validate Digital Speech Perception Endpoints in Adult Cochlear Implant Recipients Using the Mobile Research App: a Master Umbrella Investigation
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Secondary ID [1]
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AI5841
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Universal Trial Number (UTN)
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Trial acronym
VALDE-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 - the Mobile Research App
Other interventions - SOC/validated delivery of the speech perception test material
Experimental: Delivery of speech perception materials using the experimental method (Mobile Research App) -
Active Comparator: Standard of Care validated delivery of speech perception materials -
Experimental: Delivery of speech perception materials using the experimental method (MRA) in home environment -
Treatment: Devices: the Mobile Research App
The MRA speech testing module delivers speech material via streaming to the single implanted ears of cochlear implant recipients. The recipient listens to the speech material and responds with what was heard via the keypad on the app. Speech is streamed via Bluetooth from the iOS device to the sound processor of the CI-recipient.
Speech material used will be determined by the country/local language and the sub-investigation. For example, sub-investigation A, will use CNC monosyllabic words in English, in clinics only.
For example, sub-investigation B, will use CVC monosyllabic words in Dutch, in-clinic and in a home environment.
Other interventions: SOC/validated delivery of the speech perception test material
Speech material used will be determined by the country/local language and the sub-investigation.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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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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To determine if test-retest reliability
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Assessment method [1]
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To determine if test-retest reliability with a correlation greater than or equal to 0.8 can be achieved for speech perception ability measured on the MRA outside the sound booth, percent correct performance for the test and rest runs of the speech perception ability will be compared.
Scoring: Percentage correct
Range: 0-100%, higher scores equal better performance
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Timepoint [1]
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1 day - immediately post screening.
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Eligibility
Key inclusion criteria
- Adults 18 years of age or older.
- Uses a hearing device or devices (hearing aid/s and/or cochlear implant/s).
- Fluent speaker in the language used to assess clinical performance as judged by the
investigator.
- Willing and able to provide written informed consent.
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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.
- 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.
- Currently participating, or participated within the last 30 days, in another
interventional clinical investigation/trial 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).
- Women who are pregnant.
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Non-randomised 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
5/02/2024
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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
31/08/2024
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Actual
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Sample size
Target
46
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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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HEARnet Clinical Studies - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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Belgium
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State/province [2]
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Antwerp
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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 study is a feasibility, prospective, repeated-measures, multi-country, multi-centre,
study of the Mobile Research App to measure and validate speech perception endpoints in adult
cochlear implant recipients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06098482
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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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Ruth English
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Address
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Country
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Phone
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+61 3 8662 3105
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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/NCT06098482
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