Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05552118

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ear Science Institute Australia, Subiaco, Western Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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).

Treatment and study plan

Cochlear™ Remote care

Procedure

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

Procedure

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

Compatible Implant Series and Compatible Sound Processors

Device

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

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

    Time frame: 3 months post-activation (baseline) and 12 months 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

Secondary outcomes

  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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Avania
  • QbD Clinical
  • TFS

Registry information

Official study 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

Acronym: INSPIRE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.