BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
BEARS
A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants
1 other identifier
interventional
272
1 country
13
Brief Summary
The goal of the BEARS clinical trial is to determine whether using the directional 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 and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants. The 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 11, 2023
CompletedStudy Start
First participant enrolled
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
April 1, 2026
March 1, 2026
3.3 years
March 17, 2023
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
The Primary outcome for the BEARS trial is the difference between the intervention groups in speech-in-noise perception score (% correct overall task) at 3 months, accounting for the participant's baseline score. This is derived from the spatial speech in noise (SSiN-VA) test.
Three months
Secondary Outcomes (12)
SSiN-VA test outcome
Twelve months
SSiN-VA test outcome
Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes
Three and Twelve Months
British Picture Vocabulary Scale (BPVS) test outcome
Twelve Months
Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome
Three and Twelve Months
- +7 more secondary outcomes
Other Outcomes (3)
Age effects
Twelve Months
Retention of training effects
Three and Twelve Months
Impact of degree of balance between ears
Three and Twelve Months
Study Arms (2)
Both EARS training package (BEARS) and Usual Care
EXPERIMENTALBEARS 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.
Usual Care
ACTIVE COMPARATORUsual care describes the routine rehabilitation received by participants via their implant centre.
Interventions
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, 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 2x 30-minute sessions, all three games will need to be played.
This is an annual review appointment with the patient and their clinician. This could be face-to-face, virtual video consultation, questionnaire, or be 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.
Eligibility Criteria
You may qualify if:
- Participant is a simultaneous or sequential bilateral cochlear implant user\*, who either has:
- Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.
- Progressive or acquired severe/profound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) \*(a bilateral CI user is defined as a patient who uses both cochlear implant processors for a minimum of 6-hours per day over a month)
- Participant has stable programmes (defined as no longer using progressive programmes to work through).
- Participant has had at least two usual care checks/clinical appointments with stable aided levels (+/- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.
- Participant is aged 8-16 years, inclusive.
You may not qualify if:
- Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
- Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.
- Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
- Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
- Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.
- Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming.
- Participant is refusing to consent to trial activities/protocol.
- Participant is awaiting reimplantation following device failure or infection.
- 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).
- Participant is a fulltime boarder at a boarding school
- Participant has unresolvable issues found in device checks that render one of the implants unusable.
- Participant is a female that is pregnant.
- Participant has a diagnosis of epilepsy or history of seizures of any kind.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- University of Cambridgecollaborator
- University College, Londoncollaborator
- Imperial College Londoncollaborator
- University of Nottinghamcollaborator
- Cambridge University Hospitals NHS Foundation Trustcollaborator
- University of Southamptoncollaborator
- National Institute for Health Research, United Kingdomcollaborator
Study Sites (13)
The Midlands Hearing Implant Programme (Children's Service)
Birmingham, Birmingham, B4 7ET, United Kingdom
Yorkshire Auditory Implant Service
Bradford, Bradford, BD9 6RJ, United Kingdom
Emmeline Centre for Hearing Implants
Cambridge, Cambridge, CB2 0QQ, United Kingdom
Scottish Cochlear Implant Programme
Kilmarnock, Kilmarnock, KA2 0BE, United Kingdom
St Thomas' Hospital Hearing Implant Centre
London, London, SE1 7EH, United Kingdom
St George's Auditory Implant Service
London, London, SW17 OQT, United Kingdom
Auditory Implants: Royal National ENT and Eastman Dental Hospitals
London, London, WC1E 6DG, United Kingdom
Great Ormond Street Cochlear Implant Programme
London, London, WC1N 3JH, United Kingdom
The Richard Ramsden Centre for Hearing Implants
Manchester, Manchester, M13 9WL, United Kingdom
North East Regional Cochlear Implant Programme
Middlesbrough, Middlesborough, TS4 3BW, United Kingdom
Nottingham Auditory Implant Programme
Nottingham, Nottingham, NG1 5DU, United Kingdom
Oxford Auditory Implant Centre
Oxford, Oxford, OX3 9DU, United Kingdom
University of Southampton Auditory Implant Service
Southampton, Southampton, SO17 1BJ, United Kingdom
Related Publications (2)
Vickers D, Salorio-Corbetto M, Driver S, Rocca C, Levtov Y, Sum K, Parmar B, Dritsakis G, Albanell Flores J, Jiang D, Mahon M, Early F, Van Zalk N, Picinali L. Involving Children and Teenagers With Bilateral Cochlear Implants in the Design of the BEARS (Both EARS) Virtual Reality Training Suite Improves Personalization. Front Digit Health. 2021 Nov 12;3:759723. doi: 10.3389/fdgth.2021.759723. eCollection 2021.
PMID: 34870270RESULTSalorio-Corbetto M, Williges B, Lamping W, Picinali L, Vickers D. Evaluating Spatial Hearing Using a Dual-Task Approach in a Virtual-Acoustics Environment. Front Neurosci. 2022 Mar 8;16:787153. doi: 10.3389/fnins.2022.787153. eCollection 2022.
PMID: 35350560RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2023
First Posted
April 11, 2023
Study Start
July 27, 2023
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- First year of the trial opening
- Access Criteria
- Open access