Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000133831
Ethics application status
Approved
Date submitted
6/10/2020
Date registered
9/02/2021
Date last updated
8/02/2023
Date data sharing statement initially provided
9/02/2021
Date results information initially provided
8/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing usability of Remote Check on Android phones when used by adult cochlear implant recipients
Scientific title
A feasibility pilot, prospective, single centre, non-randomised, open-label, actual use testing study, assessing usability of Remote Check on Android phones when used by adult cochlear implant recipients.
Secondary ID [1] 302390 0
CLTD5791
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 319175 0
Condition category
Condition code
Ear 317145 317145 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remote Check is a feature of the Nucleus Smart App which comprises of various tests, performance measurements, datalogging, and a set of questions requiring a subjective answer by the recipient or parent/carer on sound quality and other aspects of device use. Remote Check is designed to be easy to use for a cochlear implant recipient even if they have no prior experience in using the Nucleus Smart App. No training will be provided to the participants on the use of the app; however, they will have access to the guidance inbuilt in the app.
Participants will have access to the Remote Check feature of the app on the loaner Android smartphone for the maximum duration of the trial (6 months).
Remote Check in the Nucleus Smart App includes the following tests that can be run by the recipient or their parent/carer at home: photos of the implant site and surgical scar, questionnaire, Aided Threshold Test (ATT), Digit Triplet Test (DTT), Datalogs and Telemetry measurements. Results are intended to provide relevant information for a clinician to determine if the recipient needs to attend the clinic in-person or not. Primary tasks include participants identifying that a Remote Check is due in the Nucleus Smart App’s home screen, being able to start the Remote Check and proceed through the various tests as mentioned above.
Remote Check activities in this trial are expected to take 1-2 hours in clinic and 1-2 hours at home.
Remote Check is self-administered by the subject and results reviewed by a clinical audiologist.
The results of the Remote Check will be accessed via a web-portal by the investigator to review data. In addition, the diagnostics logs from the app will be collected to assess use errors.
Intervention code [1] 318735 0
Treatment: Devices
Comparator / control treatment
Baseline Remote Check will be conducted in the Nucleus Smart App with no additional external testing.
Control group
Active

Outcomes
Primary outcome [1] 325297 0
Proportion of subjects who, while using the final version of Remote Check on Android smart phones, are able to complete all primary tasks determined by an observer using a rating scale. Unvalidated 5-point ranking scale designed specifically for usability tasks in this study.
Timepoint [1] 325297 0
Baseline, take-home visit (1-14 days post-enrolment) and follow up visit (2-6 months post-enroloment).
Secondary outcome [1] 387439 0
The test-retest difference for Aided Threshold Test (ATT) on Android smart phones, where participant performs all tests twice
Timepoint [1] 387439 0
The Remote Check performed at Visit 1 (Screening) will be compared to that conducted at home up to 6 months post-enrolment.
Secondary outcome [2] 387440 0
The test-retest difference for Digital Triplet Test (DT) on Android smart phones, where participant performs all tests twice
Timepoint [2] 387440 0
The Remote Check performed at Visit 1 (Screening) will be compared to that conducted at home up to 6 months post-enrolment.
Secondary outcome [3] 390320 0
Ease of use and usability
Timepoint [3] 390320 0
Determine the proportion of subjects who, while using the final version of Remote Check on Android smart phones, can complete the primary tasks, as assessed by the investigator / observer using a usability rating scale (Unvalidated 5-point ranking scale designed specifically for usability tasks in this study).

Eligibility
Key inclusion criteria
1. 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), N24 Series Implants: CI24R (CS), CI24R (CA), CI24R (ST), CI24M.
2. At least 3 months experience with the cochlear implant.
3. Able to complete open set speech perception test as judged by the investigator
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 within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/11/2020
Date of last participant enrolment
Anticipated
Actual
7/12/2020
Date of last data collection
Anticipated
30/06/2021
Actual
19/02/2021
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306814 0
Commercial sector/Industry
Name [1] 306814 0
Cochlear Limited
Country [1] 306814 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Limited
Address
No 1 University Avenue
Macquarie University, NSW 2109
Country
Australia
Secondary sponsor category [1] 307368 0
None
Name [1] 307368 0
Address [1] 307368 0
Country [1] 307368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306978 0
Bellberry Limited HREC
Ethics committee address [1] 306978 0
123 Glen Osmond Road Eastwood Adelaide South Australia 5063
Ethics committee country [1] 306978 0
Australia
Date submitted for ethics approval [1] 306978 0
15/09/2020
Approval date [1] 306978 0
02/11/2020
Ethics approval number [1] 306978 0

Summary
Brief summary
The purpose of the feasibility pilot is to assess the ease of use of Remote Check on Android smart phones when used by adult Cochlear Implant recipients, in terms of usability and software issues, for the completion of primary tasks. Usability will be assessed using a ranking scale and questionnaire. Software issues/bugs relevant to the use of Remote Check on Android will be logged and used to inform any product enhancements required. The study will also characterise the test retest difference of Aided Threshold Test (AAT) and Digit Triplet Test (DTT) when streamed via Android smart phones.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105630 0
Mr Saji Marythurkkara
Address 105630 0
No 1 University Avenue
Macquarie University, NSW 2109
Country 105630 0
Australia
Phone 105630 0
+61 294255637
Fax 105630 0
Email 105630 0
[email protected]
Contact person for public queries
Name 105631 0
Ms Bernadette Pickering
Address 105631 0
No 1 University Avenue
Macquarie University, NSW 2109
Country 105631 0
Australia
Phone 105631 0
+61 296119505
Fax 105631 0
Email 105631 0
[email protected]
Contact person for scientific queries
Name 105632 0
Ms Bernadette Pickering
Address 105632 0
No 1 University Avenue
Macquarie University, NSW 2109
Country 105632 0
Australia
Phone 105632 0
+61 296119505
Fax 105632 0
Email 105632 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18283Study protocol    380643-(Uploaded-03-02-2023-17-54-46)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 380643-(Uploaded-03-02-2023-17-57-30)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.