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Hearing LossINSPIRENCT05552118

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

A study testing Cochlear™ Remote care and Compatible Implant Series and Compatible Sound Processors in people with Hearing Loss, run by Cochlear at 11 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss
What is being tested?
Cochlear™ Remote care and Compatible Implant Series and Compatible Sound Processors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
11 sitesin 5 countries
Study dates
18 Mar 2024to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

11 sites in 5 countries.

11 sites in 5 countries

United Kingdom4 sites

  • Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham

    Birmingham, B15 2TH

  • Auditory Implant Centre, Glan Clwyd Hospital

    Bodelwyddan, LL18 5UJ

  • St Thomas' Hospital

    London, SE1 7EH

  • St George's Hospital

    London, SW17 0QT

Other trials in United Kingdom

Belgium2 sites

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Italy2 sites

  • University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria

    Bari, 70120

  • Azienda Ospedale Università di Padova

    Padova, 35128

Other trials in Italy

Netherlands2 sites

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 EV

  • Radboud University Medical Centre Nijmegen

    Nijmegen, 6500 HB

Other trials in Netherlands

Australia1 site

  • Ear Science Institute Australia

    Subiaco, Western Australia, 6008

Other trials in Australia

About this study

Official 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

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.

Conditions
Hearing Loss
Being tested
Cochlear™ Remote care, Standard of care, Compatible Implant Series and Compatible Sound Processors
Keywords
Cochlear Implant aftercare, Remote clinical management
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cochlear™ Remote careProcedure or surgery

    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 careProcedure or surgery

    Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro

  • Compatible Implant Series and Compatible Sound ProcessorsDevice

    Individuals who are implanted with a compatible cochlear implant series and compatible sound processor are eligible to participate.

Study groups in NCT05552118
Study groupRoleWhat they receive
Cochlear™ Remote careExperimentalIs composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.
Receives: Procedure: Cochlear™ Remote care; Device: Compatible Implant Series and Compatible Sound Processors
Standard of careActive comparatorRoutine In-clinic care
Receives: Procedure: Standard of care; Device: Compatible Implant Series and Compatible Sound Processors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months post-activation (baseline) and 12 months post-activation

Secondary outcomes (6)

  1. 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

    The test is done using phonetically balanced words and scores are recorded as % correct words. Higher scores indicate a better outcome.

    Measured: 3 months post-activation (baseline) and 12 months post-activation

  2. Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation

    The test is done using validated lists of phonetically balanced sentences. The noise is kept constant at 65 decibel (dB) Sound Pressure Level (SPL), and the speech is adapted stepwise to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. Lower scores indicate a better outcome.

    Measured: 3 months post-activation (baseline) and 12 months post-activation

  3. Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire.

    Measured: 3 months post-activation (baseline) and 12 months post-activation

  4. Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire

    Measured: 3 months post-activation (baseline) and 12 months post-activation

  5. Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation

    Measuring satisfaction of participants with the healthcare service (8 questions). Each item is scored using a 4-point Likert scale with 1 always indicating a negative response and 4 a positive response. A total higher score indicates higher satisfaction

    Measured: 12 months post-activation

  6. Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation

    Evaluating the knowledge, skills, beliefs, and behaviours that participants have for self-management of their long-term health condition (13 items). Each item is scored on a 4-point likert scale from 1 (strongly disagree) to 4 (strongly agree). The overall score is calculated and normalized to a 100-point scale. Higher scores indicate greater levels of activation.

    Measured: 12 months post-activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start18 Mar 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552118
Sponsor's protocol ID
CLTD5764
Acronym
INSPIRE
Status last verified
Sep 2025
First submitted
6 Sep 2022
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 41120152

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear™ Remote care and Compatible Implant Series and Compatible Sound Processors in people with Hearing Loss, run by Cochlear at 11 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United Kingdom, Belgium, Italy, Netherlands, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 3 months post-activation (baseline) and 12 months post-activation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05552118, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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