{ "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.\n\nMethods 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.\n\nEthics 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.\n\nTrial registration number: NCT05808543.", "abstract_shown": true, "affiliations": [ "Department of Clinical Neuroscience, SOUND Lab, University of Cambridge, Cambridge, UK", "Comprehensive Clinical Trials Unit, University College London, London, UK", "Dyson School of Engineering, Imperial College London - South Kensington Campus, London, England, UK", "Research Department of Primary Care and Population Health, University College London, London, UK", "Cochlear Implants, Guy's and St Thomas’ NHS Foundation Trust, London, England, UK", "Faculty of Brain Sciences, University College London, London, England, UK", "Heart and Lung Research Institute, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK", "Cochlear Implant, Guy's and St Thomas’ NHS Foundation Trust, London, UK", "Institute of Clinical Trials & Methodology, University College London, London, UK", "University of Southampton, Southampton, UK", "Guy's and St Thomas’ NHS Foundation Trust, London, UK", "National Acoustics Laboratory, Macquarie University, New South Wales, Australia", "Comprehensive Clinical Trials Unit, University College London, London, London, UK", "University of Nottingham, Nottingham, UK" ], "article_type": "research article", "arxiv": null, "author_total": 25, "authors": [ { "affs": [ 0 ], "name": "Deborah Vickers", "orcid": "0000-0002-7498-5637" }, { "affs": [ 0 ], "name": "Lisabeth Buelt", "orcid": "0009-0001-7027-9225" }, { "affs": [ 1 ], "name": "Liz Arram" }, { "affs": [ 2 ], "name": "Lorenzo Picinali" }, { "affs": [ 0 ], "name": "Marina Salorio Corbetto" }, { "affs": [ 1 ], "name": "Kashfia Chowdhury" }, { "affs": [ 3 ], "name": "Caroline S Clarke", "orcid": "0000-0002-4676-1257" }, { "affs": [ 1 ], "name": "Nick Freemantle" }, { "affs": [ 4 ], "name": "Dan Jiang" }, { "affs": [ 0, 5 ], "name": "Bhavisha Parmar" }, { "affs": [ 6 ], "name": "Frances Early" }, { "affs": [ 7 ], "name": "Sandra Driver" }, { "affs": [ 8 ], "name": "Ekaterina Bordea" }, { "affs": [ 1 ], "name": "Teresa Hill" }, { "affs": [ 9 ], "name": "Helen Cullington" }, { "affs": [ 10 ], "name": "Fiona Kukiewicz" }, { "affs": [ 10 ], "name": "Christine Rocca", "orcid": "0009-0005-6206-1786" }, { "affs": [ 11 ], "name": "Padraig Kitterick" }, { "affs": [ 2 ], "name": "Fleur Corbett" }, { "affs": [ 5 ], "name": "Ruth Nightingale" }, { "affs": [ 12 ], "name": "James Blackstone", "orcid": "0000-0003-4335-5269" }, { "affs": [ 1 ], "name": "Norin Ahmed" }, { "affs": [ 13 ], "name": "Sarah Somerset" }, { "affs": [ 2 ], "name": "Nejra Zalk" }, { "affs": [ 5 ], "name": "Merle Mahon" } ], "bibtex": "https://research.draconitic.com/paper/5pk4htfqbn4fs.bib", "cited_by": 0, "doi": "10.1136/bmjopen-2026-128310", "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13723878/", "id": "5pk4htfqbn4fs", "issns": [ "2044-6055", "2044-6055" ], "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-128310", "language": "en", "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "1506" ], [ "heading", "1690" ], [ "heading", "Ear, Nose and Throat/Otolaryngology" ], [ "heading", "Protocol" ], [ "openalex", "2805|Hearing Loss and Rehabilitation" ] ], "openalex": "W7223945609", "pdf_url": null, "pmcid": "PMC13723878", "pmid": "42946354", "published": "2026-10-27", "publisher": "BMJ", "ris": "https://research.draconitic.com/paper/5pk4htfqbn4fs.ris", "sources": [ { "first_seen": "2026-10-30T12:19:44Z", "native_id": "10.1136/bmjopen-2026-128310", "source": "crossref", "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-128310" }, { "first_seen": "2026-11-04T12:22:26Z", "native_id": "PMC13723878", "source": "pmc", "url": "https://doi.org/10.1136/bmjopen-2026-128310" } ], "subjects": [ { "field": "biology", "origin": "openalex:2805|Hearing Loss and Rehabilitation", "subfield": "neuroscience" } ], "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", "title_text": "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", "type": "peer-reviewed", "updated_at": "2026-11-05T12:20:37Z", "url": "https://research.draconitic.com/paper/5pk4htfqbn4fs", "venue": "BMJ Open", "versions": [] }