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BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
Sponsor: Guy's and St Thomas' NHS Foundation Trust
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.
Official title: 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
Key Details
Gender
All
Age Range
8 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
272
Start Date
2023-07-27
Completion Date
2026-10-31
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
Both EARS training package (BEARS)
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.
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 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.
Locations (13)
The Midlands Hearing Implant Programme (Children's Service)
Birmingham, Birmingham, United Kingdom
Yorkshire Auditory Implant Service
Bradford, Bradford, United Kingdom
Emmeline Centre for Hearing Implants
Cambridge, Cambridge, United Kingdom
Scottish Cochlear Implant Programme
Kilmarnock, Kilmarnock, United Kingdom
St Thomas' Hospital Hearing Implant Centre
London, London, United Kingdom
St George's Auditory Implant Service
London, London, United Kingdom
Auditory Implants: Royal National ENT and Eastman Dental Hospitals
London, London, United Kingdom
Great Ormond Street Cochlear Implant Programme
London, London, United Kingdom
The Richard Ramsden Centre for Hearing Implants
Manchester, Manchester, United Kingdom
North East Regional Cochlear Implant Programme
Middlesbrough, Middlesborough, United Kingdom
Nottingham Auditory Implant Programme
Nottingham, Nottingham, United Kingdom
Oxford Auditory Implant Centre
Oxford, Oxford, United Kingdom
University of Southampton Auditory Implant Service
Southampton, Southampton, United Kingdom