Designing a Trial of Bilateral Cochlear Implantation in Adults
FOUNDATION
Designing a Randomised Controlled Trial to Examine the Benefit of Bilateral Cochlear Implantation Compared With Unilateral Cochlear Implantation in Adults With Severe to Profound Deafness
2 other identifiers
observational
86
1 country
1
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 understanding what people are saying even when they wear hearing aids. The NHS provides a cochlear implant for one ear even though these adults are deaf in both ears. Two cochlear implants could help them understand speech in noisy environments, know where to look to see who is talking, and avoid hazards outdoors. The decision about who can receive cochlear implants and how many they can receive is based on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed that providing two cochlear implants can provide additional benefits over providing just one implant. However, they decided that there is not enough evidence to show that these additional benefits are worth the additional cost of providing the second implant. NICE recommended that a clinical trial should be conducted to gather this evidence. This study will consult with patients to explore whether the trial would be acceptable to future implant recipients. The study will also work with clinicians to design a trial comparing bilateral and unilateral implantation in adults. These clinicians will also be surveyed to assess the acceptability of the trial. A group of clinicians that span the range of professions involved in delivering the care pathway will be invited to attend a trial design workshop to establish a consensus on acceptable trial design elements from a clinical perspective. Representatives from cochlear implant manufacturers will be consulted to determine possible strategies for securing industry support for a future trial. Those who run cochlear implantation services will be engaged in a working group to gather information on the current care pathway to inform future assessments of whether bilateral implantation could be cost-effective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2017
CompletedFirst Submitted
Initial submission to the registry
September 12, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2019
CompletedMay 22, 2019
March 1, 2019
2.1 years
September 12, 2017
May 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Acceptability of trial among patients
Proportion of surveyed patients who consider the proposed trial comparing bilateral cochlear implantation to unilateral cochlear implantation to be acceptable
Day 1 (Point at which the patient completes the online patient survey)
Secondary Outcomes (3)
Acceptability of trial among clinicians
Day 1 (Point at which the clinician completes the online patient survey)
Issues related to acceptability from patient perspective
Day 1 (On the day(s) the patient focus groups are conducted)
Issues related to acceptability from clinician perspective
Day 1 (On the day the trial design workshop is conducted)
Study Arms (6)
Focus group participants
Adults who have received a cochlear implant on the National Health Service (NHS) at an auditory implant service in the United Kingdom (UK) OR Adults who have been referred to a UK auditory implant programme for assessment for cochlear implantation but who have not yet been implanted
Online patient survey participants
Adults who have received a cochlear implant on the National Health Service (NHS) at an auditory implant service in the United Kingdom (UK)
Online clinician survey participants
Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK
Trial design workshop participants
Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK
Manufacturer's forum participants
Representatives of manufacturers of cochlear implants who provide devices on the NHS
Care pathway working group participants
Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK
Interventions
No intervention will be administered to any group in this observational study.
Eligibility Criteria
Adults with bilateral severe to profound hearing loss that is eligible for cochlear implantation in the United Kingdom following guidance from the National institute for Health and Care Excellence (NICE), who have either already been implanted or who are being assessed for eligibility to be implanted. Clinicians who deliver cochlear implantation services on the National Health Service in the UK. Representatives of manufacturers of cochlear implant systems who supply implants to the National Health Service in the UK.
You may qualify if:
- 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.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nottingham University Hospitals NHS Trustlead
- National Institute for Health Research, United Kingdomcollaborator
- University of Nottinghamcollaborator
- University of Liverpoolcollaborator
- University of Southamptoncollaborator
- University of East Angliacollaborator
- National Cochlear Implant Users Association, United Kingdomcollaborator
Study Sites (1)
Medicines for Children Clinical Trials Unit, Clinical Trials Research Centre, University of Liverpool
Liverpool, L12 2AP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Padraig T Kitterick, PhD
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2017
First Posted
September 19, 2017
Study Start
June 14, 2017
Primary Completion
August 2, 2019
Study Completion
August 2, 2019
Last Updated
May 22, 2019
Record last verified: 2019-03