UnknownNot Applicable

Designing a Trial of Bilateral Cochlear Implantation in Adults

United Kingdom86 participantsStarted 2017-06-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: • None.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability of trial among patients

Timeframe: Day 1 (Point at which the patient completes the online patient survey)

Trial details

NCT IDNCT03287700

SponsorNottingham University Hospitals NHS Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08-02

Contact for this trial

Matthew Smyth

+44 151 795 8780 foundation.study@liverpool.ac.uk

View on ClinicalTrials.gov More Hearing Loss, Bilateral trials