Hearing Loss, BilateralFOUNDATIONNCT03287700
Designing a Trial of Bilateral Cochlear Implantation in Adults
An observational study of Hearing Loss, Bilateral and Hearing Loss, Sensorineural, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral, Hearing Loss, Sensorineural
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2017to 2 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Medicines for Children Clinical Trials Unit, Clinical Trials Research Centre, University of Liverpool
Liverpool, L12 2AP
Matthew Smyth, +44 151 795 8780, foundation.study@liverpool.ac.uk
About this study
Official title: 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
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.
Read the 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 issues around the acceptability of the two-arm trial recommended by NICE. The recruitment strategy will target both individuals who have been referred for a cochlear implant but have yet to receive one and also existing users of a cochlear implant. The focus groups will explore issues such as acceptance of randomisation, how to minimise the burden associated with participating, potential barriers to participation, and how to communicate the purpose of the trial clearly and effectively to prospective participants.
Online surveys Online surveys, informed by the focus groups, will be used to capture the views of the wider population of patients and of clinicians who deliver cochlear implant services on the acceptability of the trial. Both surveys will use open and closed questions. The surveys will explore the acceptability of the trial.
Trial design workshop Following the focus groups and surveys, an all-day workshop will be conducted with clinicians who deliver the current care pathway for cochlear implantation. The workshop will comprise a focus group and a trial design session. The focus group will seek to identify pertinent issues with the trial design from the perspective of the clinicians. The group will then be tasked with reaching a consensus on a trial design that would be both acceptable to them and which is feasible to conduct.
Manufacturer's forum Major manufacturers who supply cochlear implants to the NHS will be invited to attend a manufacturer's forum near the end of the study. They will be presented with the results of the acceptability assessment. The forum will explore whether the manufacturers would consider supporting the trial.
Care pathway working group A working group of cochlear implant service coordinators will be established to examine the existing decision analytic model commissioned by NICE and to identify the aspects of the model that require updating. The group will identify those parameters for which relevant information may be available from their own service records and will be tasked to reach a consensus on individual values for each parameter that would generally represent service provision across the providers. The group will also define plausible ranges for each parameter which could be used in future sensitivity analyses of any decision-analytic model.
- Being tested
- No intervention
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be administered to any group in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention | |
| 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) Receives: Other: No intervention | |
| Online clinician survey participants | Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK Receives: Other: No intervention | |
| Trial design workshop participants | Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK Receives: Other: No intervention | |
| Manufacturer's forum participants | Representatives of manufacturers of cochlear implants who provide devices on the NHS Receives: Other: No intervention | |
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 (Point at which the patient completes the online patient survey)
Secondary outcomes (3)
Acceptability of trial among clinicians
Proportion of surveyed clinicians who consider the proposed trial to be acceptable
Measured: Day 1 (Point at which the clinician completes the online patient survey)
Issues related to acceptability from patient perspective
Major themes related to acceptability from the perspectives of patients assessed using qualitative methods
Measured: Day 1 (On the day(s) the patient focus groups are conducted)
Issues related to acceptability from clinician perspective
Major themes related to acceptability from the perspectives of clinicians assessed using qualitative methods
Measured: Day 1 (On the day the trial design workshop is conducted)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start14 Jun 2017
- Primary completion2 Aug 2019 (estimated)
- Study completion2 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Nottingham, University of Liverpool, University of Southampton, University of East Anglia, National Cochlear Implant Users Association, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Padraig T Kitterick, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287700
- Sponsor's protocol ID
- 16IH004
- Other IDs
- PB-PG-0815-20039
- Acronym
- FOUNDATION
- Status last verified
- Mar 2019
- First submitted
- 12 Sep 2017
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03287700
- Acronym / sponsor ID
- FOUNDATION / 16IH004
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Nottingham, University of Liverpool, University of Southampton, University of East Anglia, National Cochlear Implant Users Association, United Kingdom
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 2 Aug 2019 (estimated)
- Study completion
- 2 Aug 2019 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 issues around the acceptability of the two-arm trial recommended by NICE. The recruitment strategy will target both individuals who have been referred for a cochlear implant but have yet to receive one and also existing users of a cochlear implant. The focus groups will explore issues such as acceptance of randomisation, how to minimise the burden associated with participating, potential barriers to participation, and how to communicate the purpose of the trial clearly and effectively to prospective participants.
Online surveys Online surveys, informed by the focus groups, will be used to capture the views of the wider population of patients and of clinicians who deliver cochlear implant services on the acceptability of the trial. Both surveys will use open and closed questions. The surveys will explore the acceptability of the trial.
Trial design workshop Following the focus groups and surveys, an all-day workshop will be conducted with clinicians who deliver the current care pathway for cochlear implantation. The workshop will comprise a focus group and a trial design session. The focus group will seek to identify pertinent issues with the trial design from the perspective of the clinicians. The group will then be tasked with reaching a consensus on a trial design that would be both acceptable to them and which is feasible to conduct.
Manufacturer's forum Major manufacturers who supply cochlear implants to the NHS will be invited to attend a manufacturer's forum near the end of the study. They will be presented with the results of the acceptability assessment. The forum will explore whether the manufacturers would consider supporting the trial.
Care pathway working group A working group of cochlear implant service coordinators will be established to examine the existing decision analytic model commissioned by NICE and to identify the aspects of the model that require updating. The group will identify those parameters for which relevant information may be available from their own service records and will be tasked to reach a consensus on individual values for each parameter that would generally represent service provision across the providers. The group will also define plausible ranges for each parameter which could be used in future sensitivity analyses of any decision-analytic model.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Focus group participants | – | Other: No interventionAdults 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 | – | Other: No interventionAdults 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 | – | Other: No interventionClinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK |
| Trial design workshop participants | – | Other: No interventionClinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK |
| Manufacturer's forum participants | – | Other: No interventionRepresentatives of manufacturers of cochlear implants who provide devices on the NHS |
| Care pathway working group participants | – | Other: No interventionClinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be administered to any group in this observational study. | Other | Care pathway working group participants, Focus group participants, Manufacturer's forum participants, Online clinician survey participants, Online patient survey participants, Trial design workshop participants |
Primary outcome
Acceptability of trial among patients
Time frame: Day 1 (Point at which the patient completes the online patient survey)
Proportion of surveyed patients who consider the proposed trial comparing bilateral cochlear implantation to unilateral cochlear implantation to be acceptable
3 secondary outcomes
Acceptability of trial among clinicians
Time frame: Day 1 (Point at which the clinician completes the online patient survey)
Issues related to acceptability from patient perspective
Time frame: Day 1 (On the day(s) the patient focus groups are conducted)
Issues related to acceptability from clinician perspective
Time frame: Day 1 (On the day the trial design workshop is conducted)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Padraig T Kitterick, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Bilateral and Hearing Loss, Sensorineural, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Smyth (+44 151 795 8780, foundation.study@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of trial among patients (time frame: Day 1 (Point at which the patient completes the online patient survey)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.