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
INSPIRE
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
1 other identifier
interventional
148
5 countries
11
Brief Summary
The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedStudy Start
First participant enrolled
March 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
January 16, 2026
September 1, 2025
2.5 years
September 6, 2022
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Measuring change of speech, spatial and hearing experiences (12 items). Each item is scored on a scale of 0 to 10 where 0 corresponds to "complete inability or complete absence of a quality" and 10 to "complete ability or complete presence of an ability". The score of a participant is determined as the mean of the 12 items. Higher scores indicate less hearing disability
3 months post-activation (baseline) and 12 months post-activation
Secondary Outcomes (6)
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
3 months post-activation (baseline) and 12 months post-activation
Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation
3 months post-activation (baseline) and 12 months post-activation
Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire.
3 months post-activation (baseline) and 12 months post-activation
Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire
3 months post-activation (baseline) and 12 months post-activation
Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation
12 months post-activation
- +1 more secondary outcomes
Study Arms (2)
Cochlear™ Remote care
EXPERIMENTALIs composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.
Standard of care
ACTIVE COMPARATORRoutine In-clinic care
Interventions
Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro
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.
Individuals who are implanted with a compatible cochlear implant series and compatible sound processor are eligible to participate.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
- QbD Clinicalcollaborator
- Avaniacollaborator
- TFScollaborator
Study Sites (11)
Ear Science Institute Australia
Subiaco, Western Australia, 6008, Australia
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
Bari, 70120, Italy
Azienda Ospedale Università di Padova
Padua, 35128, Italy
Academisch Ziekenhuis Maastricht
Maastricht, 6229 EV, Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, 6500 HB, Netherlands
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Auditory Implant Centre, Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ, United Kingdom
St Thomas' Hospital
London, SE1 7EH, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Related Publications (1)
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.
PMID: 41120152DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Katie Keyrouse
Cochlear
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2022
First Posted
September 23, 2022
Study Start
March 18, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
January 16, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.