Multicentre phase III randomised controlled trial to evaluate effectiveness of the Both EARS (BEARS) virtual reality training package to maximise hearing abilities in children and young people with bilateral cochlear implants: the BEARS protocol
14 affiliations
- 1Department of Clinical Neuroscience, SOUND Lab, University of Cambridge, Cambridge, UK
- 2Comprehensive Clinical Trials Unit, University College London, London, UK
- 3Dyson School of Engineering, Imperial College London - South Kensington Campus, London, England, UK
- 4Research Department of Primary Care and Population Health, University College London, London, UK
- 5Cochlear Implants, Guy's and St Thomas’ NHS Foundation Trust, London, England, UK
- 6Faculty of Brain Sciences, University College London, London, England, UK
- 7Heart and Lung Research Institute, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
- 8Cochlear Implant, Guy's and St Thomas’ NHS Foundation Trust, London, UK
- 9Institute of Clinical Trials & Methodology, University College London, London, UK
- 10University of Southampton, Southampton, UK
- 11Guy's and St Thomas’ NHS Foundation Trust, London, UK
- 12National Acoustics Laboratory, Macquarie University, New South Wales, Australia
- 13Comprehensive Clinical Trials Unit, University College London, London, London, UK
- 14University of Nottingham, Nottingham, UK
Abstract
Introduction: Deafness is the most common human sensory deficit. Cochlear implantation is the primary intervention for severe to profound deafness. Currently, over 7000 people have bilateral cochlear implants (CIs) in the UK most of whom are children. Patient feedback suggests that for children with bilateral CIs, everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise and that current rehabilitation techniques are not engaging or appropriate to their lifestyles. To address these issues, researchers developed the Both EARS (BEARS) training package comprised three virtual reality games to improve sound localisation and listening in noise.
Methods and analysis: This protocol describes the design and methodology of a multicentre phase III randomised controlled trial (RCT) to evaluate whether use of the BEARS training package alongside usual care compared with only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in children and young people (aged 8–16 years (inclusive)) with bilateral CIs. This RCT is currently underway in 16 clinical CI departments in National Health Service (NHS) or university hospitals across the UK. The intervention involves 3 months of spatial-listening training delivered via the BEARS training package in addition to any routine rehabilitation. The control is ‘usual care’ (routine rehabilitation clinical care pathway). The primary outcome is the difference between the intervention groups in speech-in-noise perception score at 3 months derived from the spatial speech in noise (SSiN-VA) test. Recruitment ended on 31 July 2026, and end of data collection is 31 October 2026. Data analyses will begin 30 November 2026, and first results will be reported by 31 March 2027.
Ethics and dissemination: The BEARS trial was reviewed and approved by the Yorkshire & The Humber–Sheffield Research Ethics Committee (Integrated Research Application System project ID: 319903; REC reference: 23/YH/0046). It is also registered on the UK’s clinical study registry (ISRCTN92454702). Trial results will be submitted to peer-reviewed journals and presented at scientific conferences and will be disseminated regardless of the direction of effect.
Trial registration number: NCT05808543.
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BibTeX
@article{vickers2026multicentre,
title = {{Multicentre phase III randomised controlled trial to evaluate effectiveness of the Both EARS (BEARS) virtual reality training package to maximise hearing abilities in children and young people with bilateral cochlear implants: the BEARS protocol}},
author = {Deborah Vickers and Lisabeth Buelt and Liz Arram and Lorenzo Picinali and Marina Salorio Corbetto and Kashfia Chowdhury and Caroline S Clarke and Nick Freemantle and Dan Jiang and Bhavisha Parmar and Frances Early and Sandra Driver and Ekaterina Bordea and Teresa Hill and Helen Cullington and Fiona Kukiewicz and Christine Rocca and Padraig Kitterick and Fleur Corbett and Ruth Nightingale and James Blackstone and Norin Ahmed and Sarah Somerset and Nejra Zalk and Merle Mahon},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-128310},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-128310},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Multicentre phase III randomised controlled trial to evaluate effectiveness of the Both EARS (BEARS) virtual reality training package to maximise hearing abilities in children and young people with bilateral cochlear implants: the BEARS protocol
AU - Deborah Vickers
AU - Lisabeth Buelt
AU - Liz Arram
AU - Lorenzo Picinali
AU - Marina Salorio Corbetto
AU - Kashfia Chowdhury
AU - Caroline S Clarke
AU - Nick Freemantle
AU - Dan Jiang
AU - Bhavisha Parmar
AU - Frances Early
AU - Sandra Driver
AU - Ekaterina Bordea
AU - Teresa Hill
AU - Helen Cullington
AU - Fiona Kukiewicz
AU - Christine Rocca
AU - Padraig Kitterick
AU - Fleur Corbett
AU - Ruth Nightingale
AU - James Blackstone
AU - Norin Ahmed
AU - Sarah Somerset
AU - Nejra Zalk
AU - Merle Mahon
PY - 2026
DA - 2026/10/27
JO - BMJ Open
DO - 10.1136/bmjopen-2026-128310
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-128310
AB - Introduction: Deafness is the most common human sensory deficit. Cochlear implantation is the primary intervention for severe to profound deafness. Currently, over 7000 people have bilateral cochlear implants (CIs) in the UK most of whom are children. Patient feedback suggests that for children with bilateral CIs, everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise and that current rehabilitation techniques are not engaging or appropriate to their lifestyles. To address these issues, researchers developed the Both EARS (BEARS) training package comprised three virtual reality games to improve sound localisation and listening in noise. Methods and analysis: This protocol describes the design and methodology of a multicentre phase III randomised controlled trial (RCT) to evaluate whether use of the BEARS training package alongside usual care compared with only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in children and young people (aged 8–16 years (inclusive)) with bilateral CIs. This RCT is currently underway in 16 clinical CI departments in National Health Service (NHS) or university hospitals across the UK. The intervention involves 3 months of spatial-listening training delivered via the BEARS training package in addition to any routine rehabilitation. The control is ‘usual care’ (routine rehabilitation clinical care pathway). The primary outcome is the difference between the intervention groups in speech-in-noise perception score at 3 months derived from the spatial speech in noise (SSiN-VA) test. Recruitment ended on 31 July 2026, and end of data collection is 31 October 2026. Data analyses will begin 30 November 2026, and first results will be reported by 31 March 2027. Ethics and dissemination: The BEARS trial was reviewed and approved by the Yorkshire & The Humber–Sheffield Research Ethics Committee (Integrated Research Application System project ID: 319903; REC reference: 23/YH/0046). It is also registered on the UK’s clinical study registry (ISRCTN92454702). Trial results will be submitted to peer-reviewed journals and presented at scientific conferences and will be disseminated regardless of the direction of effect. Trial registration number: NCT05808543.
SN - 2044-6055
SN - 2044-6055
ER -