Both EARS training package (BEARS) to maximise hearing abilities in older children and teenagers with bilateral cochlear implants
| ISRCTN | ISRCTN92454702 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92454702 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 319903 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | IRAS 319903, CPMS 55521 |
- Submission date
- 06/01/2023
- Registration date
- 03/04/2023
- Last edited
- 16/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
Deafness is the most frequent human sensory deficit. Cochlear implantation is the primary intervention. Currently, over 6000 people have bilateral cochlear implants (CIs) in the UK, and most of these are children. Two implants are supposed to provide better access to sound, but it is challenging to interpret and integrate what is heard from both sides. The 'Living with cochlear implants' Patient and Public Involvement group reported that everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise. They reported that current rehabilitation techniques are not engaging, or appropriate to their lifestyles. To address these issues, researchers have developed a set of virtual reality games called BEARS (Both EARS). BEARS trains sound localisation and listening in noise. These are skills required in everyday listening. The aim of this study is to determine whether using the directional listening training delivered through the BEARS training package for 3 months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two CIs. The study will be carried out in clinical CI departments in NHS or University hospitals.
Who can participate?
Patients aged 8-16 years with severe/profound bilateral hearing loss who use bilateral cochlear implants
What does the study involve?
Participants will be randomly allocated into one of two groups:
1. Receive the BEARS training package to use for 3 months alongside usual care. This group will be given a head-mounted display or iPad with the BEARS training package pre-installed. The participants will be asked to complete the BEARS training package for a minimum of 2 x 30-minute sessions a week during the 3 months and also complete a training diary and answer some questions about the BEARS training package on a weekly basis.
2. Continue with usual care
All participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9 months through online and in-person appointments. Participants and clinicians can also consent to interviews.
What are the possible benefits and risks of participating?
Participants who receive the BEARS training package of virtual reality games will be given training separate to usual care, which is hoped will develop and improve their hearing ability.
The BEARS training package will be carried out using either an Oculus virtual reality head-mounted display or an iPad with headphones. Both devices are licensed for everyday use. There are risks associated with using the Oculus virtual reality head-mounted display, which are detailed in the device’s safety manual on the Oculus website. The main risk associated with this trial and using the Oculus device is falling while playing the games. For this reason, all participants must play the games whilst sitting down on a chair.
BEARS Program Development Grant (PDG)
Some people may find it hard to take part in research, especially if they are from a minority community or feel excluded for other reasons. We want our research results to apply to everyone, so we want to make sure that the people who take part are similar to the population as a whole. We have an additional Program Development Grant from NIHR to look at how diverse the children involved in BEARS are, and how we can improve this.
PDG Work plan
We will look at the children who have agreed to take part in the first 6 months of BEARS and see if they are similar to the UK population of deaf children with implants. We will look at their ethnicity, socioeconomic status, home language, sex, number of siblings, and parent/carer educational level. However, first we will need to look at lots of different information sources to find out about the diversity of deaf children in the UK, as this is not known at the moment. We can then compare with the children recruited to BEARS and see which groups are not being included. We will hold a workshop for the BEARS team and the clinicians at the participating centres to plan how to make recruitment fairer for the rest of the trial. We will then interview children and parents who chose not to take part in BEARS and find out what put them off. We will also talk to clinicians, teachers and other family representatives to ask their opinions on what makes it difficult to be involved in BEARS. We can then plan to make the BEARS NHS roll-out after the trial more inclusive. We hope this may also help other researchers to include a more diverse population of families with deaf children in future.
Where is the study run from?
Guy’s and St Thomas’ NHS Foundation Trust and UCL’s Comprehensive Clinical Trials Unit (CCTU) (UK)
When is the study starting and how long is it expected to run for?
January 2021 to December 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who are the main contacts?
1. Debi Vickers, dav1000@medschl.cam.ac.uk
2. Liz Arram, cctu.bears@ucl.ac.uk
Contact information
Principal Investigator
University of Cambridge
SOUND Lab
Clinical Neuroscience Department
Herchel Smith Building
Cambridge Biomedical Campus
Cambridge
CB2 0SZ
United Kingdom
 ORCID ID |
0000-0002-7498-5637 |
|---|---|
| Phone | +44 (0)1223760683 |
| dav1000@medschl.cam.ac.uk |
Scientific
University of Cambridge
SOUND Lab
Clinical Neuroscience Department
Herchel Smith Building
Cambridge Biomedical Campus
Cambridge
CB2 0SZ
United Kingdom
| Phone | +44 (0)1223760683 |
|---|---|
| dav1000@medschl.cam.ac.uk |
Public
Comprehensive Clinical Trials Unit at UCL
Institute of Clinical Trials and Methodology
90 High Holborn
London
WC1V 6LJ
United Kingdom
| Phone | +44 (0)20 3108 8059 |
|---|---|
| cctu.bears@ucl.ac.uk |
Study information
| Study design | Multi-centre unblinded interventional randomized controlled Phase III trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A Phase III, unblinded, multi-centre randomised controlled trial to evaluate whether 3 months of spatial-listening training delivered via the Both EARS training package (BEARS) in addition to Usual Care compared to Usual Care alone improves hearing abilities and quality of life and is cost-effective in older children and teenagers with bilateral cochlear implants |
| Study acronym | BEARS |
| Study hypothesis | The overall aim of the BEARS clinical trial is to determine whether using the spatial-listening training delivered via the BEARS training package for 3 months alongside usual care compared to only receiving usual care improves Speech-in-Noise perception, hearing experiences, vocabulary and quality of life in young people with bilateral cochlear implants. |
| Ethics approval(s) | Approved 14/03/2023, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (+44 (0)20 71048282; sheffield.rec@hra.nhs.uk), ref: 23/YH/0046 |
| Condition | Speech-in-Noise outcomes in older children and teenagers with bilateral cochlear implants |
| Intervention | Participants will be randomized using Sealed Envelope, which is an online software application. Intervention: Both EARS training package (BEARS) and Usual Care: BEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: a head-mounted display device or an iPad with headphones. The BEARS training package comprises of three games addressing different hearing functions: speech-in-noise perception, music listening and sound-source localisation. Each game is based on an audio-visual task performed through a virtual-reality interface. Players are guided through on-screen visual prompts to support the gameplay with feedback given on their performance and progress through levels of increasing difficulty. The BEARS training package design allows for the training to be self-administered and played anywhere and at any time. There is no upper limit to the frequency of use of the BEARS training package, it is advised to play the games for a minimum of 1 hour a week over a minimum of 2 x 30-minute sessions, all three games will need to be played. Usual Care: This is an annual review appointment with the patient and their clinician. This could be face-to-face, virtual video consultation, questionnaire, or cochlear remote care checks. As a minimum this review will check the following: microphone covers changed, reported or recorded device use, all external and internal equipment working (known through no reported or recorded degradation in hearing ability). During the appointment, the clinician would establish if there were any concerns regarding the cochlear implant functioning and the patient's rehabilitation programme. They will then make any repairs or adjustments to the device and manage additional support and contact as required. Between the annual review appointments patients can attend the implant centre for repair appointments or have spare equipment posted. There is no limit to the level of contact between the patient and the implant centre. All participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9 months through online and in-person appointments. Participants and clinicians can also consent to interviews. |
| Intervention type | Behavioural |
| Primary outcome measure | Speech-in-noise perception score (% correct overall task), derived from the spatial speech in noise (SSiN-VA) test and measured at baseline and 3 months |
| Secondary outcome measures | SSiN-VA test outcomes: 1. Speech-in-noise perception score (% correct of the overall task), derived from the spatial speech in noise (SSiN-VA) test and measured at baseline and 12 months. 2. Relative localisation score (% correct), derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 3. Average reaction time (measure of listening effort) for word identification selections, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 4. Average reaction time (measure of listening effort) for location shift selection, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 5. Spatial index for word identification, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 6. Spatial index for relative localisation, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. Spatial ASL test outcomes: 1. Speech reception threshold (for better ear, worse ear, and average of both), derived from the spatial adaptive sentence list (Sp-ASL) test and measured at baseline, 3 months and 12 months. 2. Spatial release from masking score (for better ear, worse ear, and average of both), derived from the spatial adaptive sentence list (Sp-ASL) test and measured at baseline, 3 months and 12 -months. British Picture Vocabulary Scale (c) test outcome: 1. Vocabulary age, derived from the British Picture Vocabulary Scale and measured at baseline and 12 months Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome: 1. Listening-related fatigue score, derived from the Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire and measured at baseline, 3 months and 12 months Health economic outcomes: The economic evaluation will calculate incremental cost per quality-adjusted life-year (QALY) gained by offering BEARS and usual care, compared to usual care, from an NHS, Personal Social Services (PSS) and Local Education Provider perspective over the 12 months of the trial. |
| Overall study start date | 01/01/2021 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 384 |
| Participant inclusion criteria | 1. Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has: 1.1. Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤36 months of age 1.2. Progressive or acquired severe/profound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) 2. Participant has stable programmes (defined as no longer using progressive programmes to work through) 3. Participant has had at least two usual care checks/clinical appointments with stable aided levels (+/-10 dB across 500 Hz-4 kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices. 4. Participant is aged 8-16 years, inclusive *(a bilateral CI user is defined as a patient who uses both CI processors for a minimum of 6 hours per day over a month) |
| Participant exclusion criteria | Current exclusion criteria as of 02/12/2024: 1. Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments 2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions 3. Participant has a comorbid condition impacting ability to participate in intervention and/or outcome assessment 4. Participant has an audiological profile impacting ability to participate in intervention and/or outcome assessments 5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention 6. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming 7. Participant is refusing to consent to trial activities/protocol 8. Participant is awaiting reimplantation following device failure or infection 9. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month) 10. Participant is a full-time boarder at a boarding school 11. Participant has unresolvable issues found in device checks that render one of the implants unusable 12. Participant is a female that is pregnant 13. Participant has a diagnosis of epilepsy or history of seizures of any kind Previous exclusion criteria: 1. Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments 2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions 3. Participant has a comorbid condition impacting ability to participate in intervention and/or outcome assessment 4. Participant has an audiological profile impacting ability to participate in intervention and/or outcome assessments 5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention 6. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming 7. Participant is refusing to consent to trial activities/protocol 8. Participant is awaiting reimplantation following device failure or infection 9. Participant has had any changes to the programmes of either CI within the last 4 weeks 10. Participant has had a change of CI processor model or upgrade within the last 4 weeks 11. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month) 12. Participant is a full-time boarder at a boarding school 13. Participant has unresolvable issues found in device checks that render one of the implants unusable 14. Participant is a female that is pregnant 15. Participant has a diagnosis of epilepsy or history of seizures of any kind |
| Recruitment start date | 28/02/2023 |
| Recruitment end date | 30/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Cambridge
CB2 0QQ
United Kingdom
2nd Floor, Lambeth Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Building 19, Highfield
Southampton
SO17 1BJ
United Kingdom
40-41 Queen Square
London
WC1N 3AJ
United Kingdom
47-49 Huntley Street
London
WC1E 6DG
United Kingdom
Ground Floor, Lanesborough Wing
St George’s Hospital
London
SW17 0QT
United Kingdom
Aston University Campus
Birmingham
B4 7ET
United Kingdom
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
University Hospital Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
21 Andersonstown Rd
Belfast
BT11 9AF
United Kingdom
Peter Mount Building
Oxford Road
Manchester
M13 9WL
United Kingdom
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
16th Floor, Tower Wing, Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)20 7188 7188 |
|---|---|
| r&d@gstt.nhs.uk | |
| Website | http://www.guysandstthomas.nhs.uk/Home.aspx |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | The trial results will be disseminated regardless of the direction of effect. The results publication will comply with the BEARS-specific publication policy (generated through BEARS Work Package 8 on Dissemination) and will include submission to open-access journals. A lay summary of the results will also be produced and uploaded to the BEARS trial website. All participants will be able to view this document. This has been detailed in the patient information sheets. A summary of results will be included online on the publicly accessible HRA website within 12 months of trial closure. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication and the datasets generated during and/or analysed during the current study will be available upon formal request to the study Sponsor, Programme Management Group, Programme Steering Committee and NIHR’s approval. The exact data types that will be available for sharing, the duration and restrictions on use will be further detailed pending the completion of the trial publication policy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
16/04/2025: The recruitment end date was changed from 30/04/2025 to 30/07/2025.
04/02/2025: Plain English summary updated.
03/12/2024: Ethics approval details added.
02/12/2024: The following changes were made to the study record:
1. The exclusion criteria were updated.
2. The recruitment end date was changed from 31/12/2024 to 30/04/2025.
3. University of Southampton Auditory Implant Service, Great Ormond Street Hospital, Cochlear Implant Programme, UCLH, Auditory Implants Programme, St George's Hospital, Auditory Implant Service, Birmingham Paediatric Cochlear Implant Programme, Nottingham Cochlear Implant Programme, Oxford Auditory Implant Programme, The Scottish Cochlear Implant Programme, North East Regional Cochlear Implant Programme, Belfast Auditory Implant Centre, Manchester Royal Infirmary, Cochlear Implant Department, and Yorkshire Auditory Implant Service were added to the study participating centres.
21/02/2023: Trial's existence confirmed by the NIHR.
