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
NCT ID: NCT05552118
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
148 participants
INTERVENTIONAL
2024-03-18
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Cochlear™ Remote care
Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.
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.
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.
Standard of care
Routine In-clinic care
Standard of care
Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro
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.
Interventions
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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.
Standard of care
Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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QbD Clinical
INDUSTRY
Avania
INDUSTRY
TFS
UNKNOWN
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Katie Keyrouse
Role: STUDY_DIRECTOR
Cochlear
Locations
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Ear Science Institute Australia
Subiaco, Western Australia, Australia
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
Bari, , Italy
Azienda Ospedale Università di Padova
Padua, , Italy
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, , Netherlands
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
Birmingham, , United Kingdom
Auditory Implant Centre, Glan Clwyd Hospital
Bodelwyddan, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Countries
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References
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Quaranta N, Murri A, Denys S, Verhaert N, Huinck W, Townsend J, Swinnen F, Dhooge I, de Klerk A, Mehta D, Brotto D, Craddock L, Hoskam G, Schou IM, McBride ME, Campbell-Bell C. Randomised controlled trial to assess the efficiency and effectiveness of remote care compared with in-clinic care for adult cochlear implant recipients in the first 12 months after activation: a protocol of the INSPIRE study. BMJ Open. 2025 Oct 20;15(10):e094283. doi: 10.1136/bmjopen-2024-094283.
Other Identifiers
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CLTD5764
Identifier Type: -
Identifier Source: org_study_id
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