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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/NCT04987021
Registration number
NCT04987021
Ethics application status
Date submitted
27/07/2021
Date registered
3/08/2021
Date last updated
21/02/2024
Titles & IDs
Public title
An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients
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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
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Secondary ID [1]
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CLTD5809
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Universal Trial Number (UTN)
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Trial acronym
RAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Sensorineural
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Hearing Loss, Bilateral
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Condition category
Condition code
Ear
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Deafness
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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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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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)
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Assessment method [1]
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Usability rating scale: 1 = unable to complete; 2 = Completed after help using document; 3 = Completed after trying an incorrect option; 4 = Completed after some exploration; 5 = Complete at first attempt.
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Timepoint [1]
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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.
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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.
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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
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.
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
N/A
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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
Single group
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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
Completed
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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
27/08/2021
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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
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Actual
28/01/2022
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Cochlear Sydney In-house lab - Sydney
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Recruitment postcode(s) [1]
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2109 - Sydney
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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
Clinical management of cochlear implant (CI) recipients involve programming, counselling,
performance evaluation and habilitation. This requires the recipients to travel to the clinic
for follow up appointments which can pose significant challenges for recipients, particularly
those who live far away from the clinic. Remote Assist (RA) is a new solution that allows the
clinician to make MAP and sound processor adjustments via the recipient's Nucleus Smart app
(NSA) installed on their smart phone. With RA the clinician can also perform counselling
using a video call directly via the NSA. As RA uses no specialized hardware and software that
needs to be sent and retrieved back from the recipient, it has the potential to further
improve the remote programming experience and convenience for both the recipient and the
clinician.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04987021
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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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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04987021
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