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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05552118




Registration number
NCT05552118
Ethics application status
Date submitted
6/09/2022
Date registered
23/09/2022
Date last updated
5/06/2025

Titles & IDs
Public title
Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation
Scientific title
A Post-Market, Prospective, Multi-Centre, Open-Label, Comparative, Interventional Study of Adult Cochlear Implant Speech Performance and Clinic Efficiency With Remote Care (Remote Check & Remote Assist) Compared With Standard of Care in the First 12 Months Post-initial Activation
Secondary ID [1] 0 0
CLTD5764
Universal Trial Number (UTN)
Trial acronym
INSPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Cochlear™ Remote care
Treatment: Surgery - Standard of care
Treatment: Devices - Compatible Implant Series and Compatible Sound Processors

Experimental: Cochlear™ Remote care - Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.

Active comparator: Standard of care - Routine In-clinic care


Treatment: Surgery: Cochlear™ Remote care
Cochlear™ Remote Check is a virtual assessment tool which helps the clinician to monitor the participant hearing progress remotely. It allows the participant to complete a series of hearing tests using the Cochlear™ Nucleus® Smart App then electronically send the results to the clinician for review.

Cochlear™ Remote Assist enables a video call appointment through the Cochlear™ Custom Sound® Pro software and the Nucleus® Smart App. When remote check requires further follow-up, it allows the clinician to make programming adjustments and sound processor settings without a clinic visit.

Treatment: Surgery: Standard of care
Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro

Treatment: Devices: Compatible Implant Series and Compatible Sound Processors
Individuals who are implanted with a compatible cochlear implant series and compatible sound processor are eligible to participate.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in patient reported hearing ability in daily life measured with the SSQ12 (Speech, Spatial and Qualities of Hearing Scale) questionnaire between month 3 (baseline) and month 12 post-activation
Timepoint [1] 0 0
3 months post-activation (baseline) and 12 months post-activation
Secondary outcome [1] 0 0
Mean change in speech recognition score for an open-set word recognition measure in quiet between 3 months post-activation (baseline) and 12 months post-activation
Timepoint [1] 0 0
3 months post-activation (baseline) and 12 months post-activation
Secondary outcome [2] 0 0
Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation
Timepoint [2] 0 0
3 months post-activation (baseline) and 12 months post-activation
Secondary outcome [3] 0 0
Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire.
Timepoint [3] 0 0
3 months post-activation (baseline) and 12 months post-activation
Secondary outcome [4] 0 0
Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire
Timepoint [4] 0 0
3 months post-activation (baseline) and 12 months post-activation
Secondary outcome [5] 0 0
Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation
Timepoint [5] 0 0
12 months post-activation
Secondary outcome [6] 0 0
Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation
Timepoint [6] 0 0
12 months post-activation

Eligibility
Key inclusion criteria
* Aged 18 years or older (no upper age limit)
* Post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant
* Unilaterally implanted with a compatible Cochlear™ implant
* Currently using a compatible Cochlear™ Sound Processor
* 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
* Direct access to a compatible Smart Phone
* Fluent in the languages used for the study, as determined by the investigator
* Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
* 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
* Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming:

* Non-monopolar MAPs (bipolar, common ground, variable mode)
* Dynamic range of <10 Comfortable Level (CL)
* Hybrid mode enabled
* Pulse widths >100 µs
* 10 or more electrodes turned off
* Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances
* Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation
* Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)
* Abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the Investigator
* Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues
* 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
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, 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).

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
18/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
148
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Ear Science Institute Australia - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Italy
State/province [3] 0 0
Bari

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
Katie Keyrouse
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
PRS Specialist, Clinical Affairs
Address 0 0
Country 0 0
Phone 0 0
+61 2 9428 6555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05552118