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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04987021




Registration number
NCT04987021
Ethics application status
Date submitted
27/07/2021
Date registered
3/08/2021

Titles & IDs
Public title
An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients
Scientific title
An Actual Use, Prospective, Adaptive Design, Single Centre, Non-randomised, Open-label Study, Assessing Usability of Remote Assist When Used to Program Cochlear Implant Recipients
Secondary ID [1] 0 0
CLTD5809
Universal Trial Number (UTN)
Trial acronym
RAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Sensorineural 0 0
Hearing Loss, Bilateral 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants

Experimental: Nucleus Smart App with Remote Assist Custom Sound Pro 6.3 - Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors.


Treatment: Devices: Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants
The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who While Using the Final Version of Remote Assist, Are Able to Complete the Primary Tasks (Score of 5 on the Usability Rating Scale)
Timepoint [1] 0 0
Immediately after the participants´ first use of the Nucleus Smart App with Remote Assist Custom Sound Pro 6.3, on average half an hour after participants have completed all tasks.

Eligibility
Key inclusion criteria
1. Adults (=18 years).
2. Implanted with the below cochlear implants in one or both ears. CI500 series (CI512, CI513, CI522, CI532,), CI600 series (CI612, CI622, CI632), Freedom series (CI24RE (ST), CI24RE (CA), CI24RE (CS), CI422).
3. At least 3 months experience with the cochlear implant.
4. 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
1. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
2. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
3. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
4. Currently participating or participated in another interventional clinical study/trial in the past 30 days, or if less than 30 days the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.

Study design
Purpose of the study
Other
Allocation to intervention
NA
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
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/01/2022
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cochlear Sydney In-house lab - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04987021