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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06098482




Registration number
NCT06098482
Ethics application status
Date submitted
19/10/2023
Date registered
24/10/2023
Date last updated
19/09/2024

Titles & IDs
Public title
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
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
Secondary ID [1] 0 0
AI5841
Universal Trial Number (UTN)
Trial acronym
VALDE-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 - 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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine if test-retest reliability
Timepoint [1] 0 0
1 day - immediately post screening.

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.
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.
* 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.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
5/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
HEARnet Clinical Studies - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerp

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06098482
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
Ruth English
Address 0 0
Country 0 0
Phone 0 0
+61 3 8662 3105
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06098482