RecruitingNot ApplicableNCT05808543

BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants

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


Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrollment

272 participants

Start Date

Jul 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Both EARS training package (BEARS) and Usual Care for people with deafness, hearing impaired children and adolescents, and other related conditions. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBoth 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.

OTHERUsual 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

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NCT05808543


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