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RECRUITING
NCT05808543
NA

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

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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