CLTD5764 INSPIRE

• Research type

  Research Study

• Full 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

• IRAS ID

  318811

• Contact name

  Louise Craddock

• Contact email

  Louise.Craddock@uhb.nhs.uk

• Sponsor organisation

  Cochlear Limited

• Clinicaltrials.gov Identifier

  NCT05552118

• Duration of Study in the UK

  1 years, 11 months, 00 days

• Research summary

  What is this study trying to find out?
  Cochlear™ Remote Care technology allows cochlear implant (CI) patients access to testing and programming of their implant from home, using an app on their smartphone. The INSPIRE (Implant speech performance and clinic efficiency with Remote Care) study will look at whether these checks are performed just as well through Remote Care as in clinic. It will also explore patients’ experiences using this approach and how it compares with attending in-clinic appointments.

  Why is this study needed?
  In the first year after receiving a CI, a patient is required to visit the clinic for multiple appointments with their audiologist. This can put a lot of pressure on those patients who need to travel long distances, take time off work and/or organise child support to visit the clinic. Also, many clinics are providing care to more and more CI patients, meaning waiting times for appointments are getting longer. Remote Care may help reduce the need for patients to travel to the clinic and help clinics to better manage the extra patients.

  What will the study involve?
  Patients aged 18 years and above who have had their CI for 3 months will be invited to take part in the study. Those who agree, and meet the study criteria to take part, will be randomly assigned to one of two groups. One group will continue to have in-clinic appointments, the other group will have appointments through Remote Care. During the study, participants will complete hearing tests and questionnaires on travel time and costs; satisfaction; and hearing difficulty in different situations. Each participant will be followed for 9 months. The results of these assessments will be analysed and compared between the two groups and presented at a scientific conference or in a scientific publication.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  22/WM/0266

• Date of REC Opinion

  19 Jan 2023

• REC opinion

  Further Information Favourable Opinion