Status:

UNKNOWN

Designing a Trial of Bilateral Cochlear Implantation in Adults

Lead Sponsor:

Nottingham University Hospitals NHS Trust

Collaborating Sponsors:

National Institute for Health Research, United Kingdom

University of Nottingham

Conditions:

Hearing Loss, Bilateral

Hearing Loss, Sensorineural

Eligibility:

All Genders

18+ years

Brief Summary

In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understandin...

Detailed Description

The study design comprises focus groups, online surveys, a trial design workshop, a manufacturer's forum, and a care pathway working group. Focus groups Two focus groups will be conducted to explore ...

Eligibility Criteria

Inclusion

  • All participants will be 18 years or older at the time consent is obtained.
  • Patients who participate in the focus groups and/or online survey must have received a cochlear implant on the NHS in the UK or must be currently being assessed for eligibility to receive a unilateral cochlear implantation by an NHS service provider.
  • Clinicians who participate in the trial design workshop and/or the online survey must be employed by a provider of NHS cochlear implantation services in the UK and be a clinically-trained professional who delivers one or more aspects of the cochlear implantation care pathway.
  • Representatives from manufacturers who attend the industry forum must be employed by a manufacturer of cochlear implants and hold a role that includes responsibility for developing, co-ordinating, or managing research activity sponsored and/or funded by the manufacturer.
  • Clinicians who participate in the care pathway working group must be employed by a provider of NHS cochlear implantation services in the UK and have a head of service or co-ordinator role in their cochlear implant service or have been delegated responsibility to contribute on behalf of a head of service / co-ordinator.

Exclusion

  • • None.

Key Trial Info

Start Date :

June 14 2017

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 2 2019

Estimated Enrollment :

86 Patients enrolled

Trial Details

Trial ID

NCT03287700

Start Date

June 14 2017

End Date

August 2 2019

Last Update

May 22 2019

Active Locations (1)

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1

Medicines for Children Clinical Trials Unit, Clinical Trials Research Centre, University of Liverpool

Liverpool, United Kingdom, L12 2AP