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

Browse trials for

• Hearing Loss 1,092

Keywords

• Cochlear Implant aftercare
• Remote clinical management

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 148 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.

Lead sponsor

Cochlear is the lead sponsor of 91 studies on the registry; 11 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.

Study arms

• Experimental
  Cochlear™ Remote care

  Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.

  Procedure: Cochlear™ Remote care · Device: Compatible Implant Series and Compatible Sound Processors

• Active comparator
  Standard of care

  Routine In-clinic care

  Procedure: Standard of care · Device: Compatible Implant Series and Compatible Sound Processors

Interventions

• ProcedureCochlear™ 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.

• ProcedureStandard of care

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

• DeviceCompatible Implant Series and Compatible Sound Processors

  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

   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

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

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

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

   Time frame: 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.

   Time frame: 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.

   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

   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

   Time frame: 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.

   Time frame: 12 months post-activation

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 ↗

Individual participant data

Plan to share: 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.