Comparing cochlear implants with hearing aids in adults with severe hearing loss
| ISRCTN | ISRCTN15352106 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15352106 |
| IRAS number | 297574 |
| Secondary identifying numbers | CPMS 50095, IRAS 297574 |
- Submission date
- 30/09/2021
- Registration date
- 01/10/2021
- Last edited
- 21/08/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
In the UK, cochlear implants are provided to some people with severe or profound hearing loss who do not get enough benefit from their hearing aids. Cochlear implants can improve their ability to recognise sounds and understand speech. Currently, only these adults are offered a cochlear implant on the NHS.
This study aims to find out whether some adults who are not currently offered a cochlear implant on the NHS would benefit more from a cochlear implant than they would from using hearing aids alone. These people are those whose hearing or speech test results are just outside of the range that would make them eligible for a cochlear implant on the NHS. It is not known if cochlear implantation is a good treatment option compared to hearing aids for these people.
Who can participate?
Patients aged 18 years and over with severe hearing loss
What does the study involve?
Participants are randomly allocated to receive a cochlear implant or new hearing aids (or can choose to continue to wear their own). The researchers will compare how well the two groups can understand speech after 9 months.
What are the possible benefits and risks of participating?
Both treatments in this study are already available as standard NHS procedures but only for people who meet the current NHS eligibility criteria. Like any treatment, both have possible disadvantages and risks. For the cochlear implant group some risks following surgery may include potential loss of the natural hearing the patient had before (meaning that the patient might not be able to go back to using a hearing aid if they weren’t happy with the cochlear implant), temporary facial weakness, tinnitus, meningitis, pain and discomfort, as well as the normal risks associated with surgery and general anaesthesia. For the hearing aid group the risks may include pain and discomfort from the use of the new hearing aids, ear infections and exacerbation of eczema.
Where is the study run from?
Nottingham Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
January 2021 to May 2026
Who is funding the study?
Cochlear Ltd (Australia)
Who is the main contact?
Mrs Imogen Parker
coach@nottingham.ac.uk, +44 (0)7773 206 747
Contact information
Scientific
Nottingham Clinical Trials Unit
Applied Health Research Building
School of Medicine
University of Nottingham
University Park
Nottingham
NG7 2RD
United Kingdom
| Phone | +44 (0)7773 206 747 |
|---|---|
| coach@nottingham.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Device, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN15352106_PIS_V1.8_11Jan24.pdf |
| Scientific title | The COACH trial: A randomised controlled trial of cochlear implantation versus hearing aids in adults with severe hearing loss |
| Study acronym | COACH |
| Study hypothesis | Primary objective: To evaluate the effect of cochlear implantation on speech understanding in quiet in comparison to the use of acoustic hearing aids (HAs) in adults with severe hearing loss whose audiometric thresholds and/or speech perception scores fall outside current UK candidacy criteria for cochlear implantation (as per NICE guidance TA566). Secondary objectives: 1. To evaluate the effect of cochlear implantation on broader hearing-related outcomes including speech understanding in noise, difficulties with listening in everyday environments, listening-related fatigue, and tinnitus in comparison to those using acoustic HAs 2. To evaluate the effect of cochlear implantation on broader health and well-being outcomes including mood, hearing-related quality of life, and health-related quality of life in comparison to those using acoustic HAs 3. To assess the safety of cochlear implantation and acoustic HAs. To characterise the duration and nature of cochlear implant (CI) and HA use |
| Ethics approval(s) | Approved 07/09/2021, South West – Frenchay Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8106; frenchay.rec@hra.nhs.uk), REC ref: 21/SW/0098 |
| Condition | Severe hearing loss |
| Intervention | This trial aims to find out whether a certain group of adults who are not currently offered a cochlear implant on the NHS would benefit more from a cochlear implant than they would from using hearing aids. These people are those whose hearing or speech test results are just outside of the range that would make them eligible for a cochlear implant on the NHS. In the trial, some people will receive a cochlear implant, and some will receive new hearing aids (or can choose to continue to wear their own). The researchers will compare how well the two groups can understand speech after 9 months. Participants will be individually randomised on a 1:1 ratio, minimised by trial site, severity of tinnitus and baseline AB word test phoneme score. The randomisation system is via REDCap, a browser-based data capture system. Intervention: Unilateral (in one ear) cochlear implantation and offer of a new acoustic hearing aid or optimisation of current hearing aid in the other ear. Comparator: Offer of new bilateral (both ears) acoustic hearing aids or optimisation of current hearing aids. Participants will be followed up at 1, 3, 6 and 9-months post treatment activation. The primary outcome will be collected at the 9-month timepoint as clinicians report that the identification of words following cochlear implantation stabilises between approximately 3-6 months and therefore assessment at 9 months will ensure stabilised performance has been reached. Qualitative Study: Process Evaluation Within this trial the researchers will deliver a process evaluation by talking to different groups of participants and healthcare workers involved in the trial about their feelings and experiences, to better understand the results of the COACH trial and inform future implementation. This will involve the following: 1. 30 participants randomised to the intervention (CI arm) who will be interviewed at two timepoints: post randomisation but before cochlear implantation and at the 9 month follow up appointment following first treatment activation 2. 15 participants randomised to the comparator (HA) arm who will be interviewed once, within 6 weeks of randomisation 3. 20 healthcare professionals who are participating in the COACH trial and their interview will take place in the final months of the trial 4. 6 individuals that declined when invited to participate in the COACH trial who will be interviewed once, within 6 weeks of their recruitment approach All interviews will be semi-structured with open questions, will be audio-recorded and undertaken face-to-face where possible. Recruitment Intervention As equipoise is highly important in the COACH trial, and many audiology staff members will be inexperienced in research processes and regulations, recruitment and consent conversations between the healthcare staff and potential participants will be monitored and reviewed. This is to ensure the information is explained well to potential participants and that the issues of equipoise are covered and to make any improvements or provide extra training to the healthcare staff is necessary. A member of the COACH trial team from the University of Nottingham will observe the conversations, either in person or via video call, and may audio-record some conversations, with permission from both the potential participant and the healthcare staff. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cochlear implant, hearing aids |
| Primary outcome measure | The perception of phonemes as quantified by the phoneme score on the AB word test (a measure of speech understanding) presented at 60 dBA in the best-aided condition (i.e., using the devices that the participant considers will help them hear as well as possible); Timepoint(s): 9 months post first treatment activation (intervention arm: first CI activation; comparator arm: first HA fitting/optimisation) measured by independent blinded assessors. |
| Secondary outcome measures | 1. Phoneme perception measured using the AB Word test at 60 dBA; Timepoint(s): 3, 6 and 9 months following first treatment activation, measured by the audiologist 2. Word perception measured using the AB Word test at 60 dBA; Timepoint(s): 3, 6 and 9 months following first treatment activation 3. Phoneme perception measured using the AB Word test at 70 dBA; Timepoint(s): 9 months following first treatment activation 4. Word perception measured using the AB Word test at 70 dBA; Timepoint(s): 9 months following first treatment activation 5. Sentence perception in quiet measured using the BKB sentence test at 70 dBA; Timepoint(s): 3, 6 and 9 months following first treatment activation 6. Sentence perception in noise measured using the Adaptive BKB sentence test; Timepoint(s): 3, 6 and 9 months following first treatment activation 7. Speech sound discrimination measured using the Phoneme discrimination test; Timepoint(s): 9 months following first treatment activation 8. Device usage measured using device logging; Timepoint(s): 3, 6, and 9 months 9. Audiometric thresholds (aided and unaided) measured using clinical equipment; Timepoint(s): On the day of treatment activation and at 3, 6 (unaided only) and 9 months following first treatment activation 10. Difficulty with listening measured using the 12-item Speech Spatial and Qualities of listening scale (SSQ12); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 11. Listening effort and fatigue measured using the Effort Assessment Scale (EAS), Fatigue Assessment Scale (FAS), Listening Effort Questionnaire-Cochlear Implant (LEQ-CI); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 12. Tinnitus severity measured using the Tinnitus Functional Index (TFI); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 13. Tinnitus loudness measured using the Visual Analogue Scale of Loudness (VAS-L); Timepoint(s): Immediately before and after first treatment activation and at 1, 3, 6, and 9 months post first treatment activation 14. Mood measured using the Hospital Anxiety and Depression Scale (HADS); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 15. Hearing-specific quality of life measured using the Nijmegen Cochlear Implant Questionnaire (NCIQ), York Binaural Hearing-Related Quality of Life (YBHRQL), Hearing Handicap Inventory for Adults (HHIA); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation 16. Global ratings of change in hearing and quality of life measured using validated patient-reported outcome measures (PROMs); Timepoint(s): 1, 3, 6, and 9 months post first treatment activation |
| Overall study start date | 01/01/2021 |
| Overall study end date | 31/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 130; UK Sample Size: 130 |
| Participant inclusion criteria | 1. Adults aged 18 years or older 2. Patients with a severe sensorineural hearing loss in both ears (pure-tone audiometric threshold equal to or greater than 70 dB HL) at two or more frequencies (500 Hz, 1,000 Hz, 2,000 Hz, 3,000 Hz and 4,000 Hz) bilaterally without acoustic hearing aids 3. Patients with appropriate hearing aid devices and prescriptions, with a minimum of 3 months having elapsed since any change in devices or prescriptions 4. Patients with a phoneme score <60% on the AB Word test when tested in quiet at 70 dBA with acoustic hearing aids 5. Patients in whom history, examination and pre-operative imaging suggests a healthy middle ear in the ear to be implanted, and a structurally normal and fully patent cochlea with no evidence of a widened vestibular aqueduct 6. Patients for whom unilateral cochlear implantation is not recommended by NICE either because they do not meet the definition of severe to profound deafness (pure-tone audiometric threshold equal to or greater than 80 dB HL at two or more frequencies between 500 Hz, 1,000 Hz, 2,000 Hz, 3,000 Hz and 4,000 Hz), or because they meet the definition of adequate benefit from HAs (a phoneme score >= 50% on the AB Word test when tested in quiet at 70 dBA with acoustic hearing aids), or both (as per recommendation 1.5, NICE TA566) 7. Patients who are capable of speaking and understanding the English language 8. Patients who are capable and willing to provide written informed consent |
| Participant exclusion criteria | 1. Patient characteristics falling outside the indications for use of the trial devices as per their CE marking 2. Inability to undergo speech perception testing and/or inability of audiologist to obtain an accurate measurement of speech perception abilities 3. Patients who would not be able to adhere to trial procedures or complete the trial questionnaires 4. Patients whose hearing loss is suspected or confirmed to be wholly or partly unexplained by anatomic or physiologic abnormalities (non-organic hearing loss) 5. Patients who have a congenital severe hearing loss 6. Any known factor that may restrict the full insertion of the electrode array 7. Patients with any known contraindication for cochlear implantation 8. Patients whose primary concern is the suppression of tinnitus 9. Patients in whom cochlear implantation would present an unacceptable risk to balance function 10. Any serious concerns about medical fitness for surgery or cochlear implantation 11. Participation in other research related to hearing loss while participating in the trial (i.e., until collection of primary outcome), including research that involves any changes to or use of hearing devices, changes to hearing care/management, or duplication of trial outcome assessments |
| Recruitment start date | 04/10/2021 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Nottingham
NG7 2UH
United Kingdom
Manchester
M13 9WL
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Maes-Y-Coed Road
Cardiff
CF14 4HH
United Kingdom
London
NW1 2PG
United Kingdom
London
SE1 7EH
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
University/education
Research and Innovation
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
England
United Kingdom
| Phone | +44 (0)115 7486731 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Cochlear Ltd.
- Location
- Australia
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The protocol will be published on the COACH website (https://www.coachtrial.ac.uk). Methodology papers will be published for both the main trial and the process evaluation, and trial results papers in high-impact, peer-reviewed journals. The COACH trial will be presented at national and international conferences, such as the British Cochlear Implant Group annual conference and the biannual Conference on Implantable Auditory Prostheses. Dissemination activities, such as short bulletins, articles in charity and support group newsletters, blogs, our own study newsletters, audio-visual and social media will be agreed and developed with the patient research partners group to keep participants, people with hearing loss and the general public engaged and informed throughout the trial and in sharing outcomes. |
| IPD sharing plan | In compliance with the ICH/GCP guidelines, regulations and in accordance with the University of Nottingham Research Code of Conduct and Research Ethics, the Chief or local Principal Investigator will maintain all records and documents regarding the conduct of the trial. These will be retained for at least 7 years or for longer if required. If the responsible investigator is no longer able to maintain the trial records, a second person will be nominated to take over this responsibility. The TMF and trial documents held by the Chief Investigator and the NCTU on behalf of the Sponsor shall be finally archived at secure archive facilities at the University of Nottingham. This archive shall include all trial databases and associated meta-data encryption codes. All trial staff and investigators will endeavour to protect the rights of the trial’s participants to privacy and informed consent, and will adhere to the Data Protection Act, 2018. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | version 1.8 | 11/01/2024 | 16/05/2024 | No | Yes |
| Protocol file | version 6.2 | 20/03/2024 | 16/05/2024 | No | No |
| Protocol file | version 6.3 | 15/05/2024 | 20/08/2024 | No | No |
Additional files
Editorial Notes
21/08/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2024 to 31/08/2025.
2. The overall end date was changed from 31/08/2025 to 31/05/2026.
3. The plain English summary was updated to reflect these changes.
20/08/2024: The following changes were made to the trial record:
1. Uploaded protocol v6.3 (not peer-reviewed) as an additional file.
2. The overall end date was changed from 31/05/2025 to 31/08/2025.
3. The intention to publish date was changed from 01/02/2025 to 31/12/2026.
16/05/2024: Protocol and participant information sheet uploaded. Addenbrookes Hospital was removed from the study participating centres.
08/03/2024: The following changes were made:
1. The overall study end date was changed from 31/07/2024 to 31/05/2025.
2. The study telephone number was updated.
13/11/2023: The following changes were made:
1. The scientific contact was updated.
2. The James Cook University Hospital was added as a study participating centre.
12/06/2023: The following changes were made to the study record:
1. Participant information sheet uploaded.
2. Study website added.
3. The recruitment end date was changed from 04/05/2023 to 31/08/2024.
4. Contact details updated.
5. Bristol Royal Infirmary was removed as a study participating centre.
17/11/2021: The recruitment end date has been changed from 04/04/2023 to 04/05/2023.
30/09/2021: Trial's existence confirmed by the NIHR.
