Actively Recruiting

Phase Not Applicable
Age: 8Years - 16Years
All Genders
ID05808543

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

Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2026-04-01

272

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

Sponsors

G

Guy's and St Thomas' NHS Foundation Trust

Lead Sponsor

U

University of Cambridge

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether using the Both EARS (BEARS) training package alongside usual care for three months can improve hearing abilities in children and teenagers aged 8 to 16 with two cochlear implants. The study focuses on improving speech understanding in noisy environments, hearing experiences, vocabulary, quality of life, and reducing listening effort. The trial is conducted in clinical cochlear implant departments within National Health Service or University hospitals. Participants will be randomly assigned to one of two groups: one group will use the BEARS training package, which includes virtual reality games targeting speech-in-noise perception, music listening, and sound localization, alongside their usual care. The other group will continue with usual care alone. The BEARS training is designed to be self-administered using either a head-mounted display or iPad with headphones, with a recommended minimum of two 30-minute sessions per week over three months. Participants will undergo hearing assessments and complete questionnaires before starting the intervention. They will be followed up for nine months after the three-month intervention period through online and in-person visits. The study measures include spatial speech-in-noise test results, vocabulary tests, fatigue scales, hearing quality questionnaires, and health economic outcomes. Participants and clinicians may also participate in interviews related to the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is a simultaneous or sequential bilateral cochlear implant user who uses both processors for at least 6 hours per day over a month
  • Participant has congenital severe/profound bilateral sensorineural hearing loss with at least one implant received by 36 months of age, or progressive/acquired severe/profound bilateral sensorineural hearing loss without implant age restrictions
  • Participant has stable cochlear implant programs with no progressive adjustments
  • Participant has had at least two usual care clinical appointments with stable hearing levels (+/-10 dB across 500Hz-4kHz)
  • Participant is aged 8 to 16 years inclusive
Not Eligible

You will not qualify if you...

  • Participant or parent/legal representative does not speak or understand English well enough to undertake assessments
  • Participant has an intellectual disability preventing understanding of the trial or assessments
  • Participant has a comorbid condition affecting ability to participate in the intervention or assessments
  • Participant has an audiological profile impacting participation
  • Participant is currently in other trials that may affect hearing outcomes or participation
  • Participant is currently receiving or expected to receive treatments affecting hearing or implant settings
  • Participant refuses consent to trial activities
  • Participant is awaiting reimplantation due to device failure or infection
  • Participant is a non-user of one or both implant processors
  • Participant is a full-time boarder at a boarding school
  • Participant has unresolvable device issues making an implant unusable
  • Participant is a pregnant female
  • Participant has epilepsy or a history of seizures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) to determine eligibility and consent

Treatment

Duration - 3 months

Participants either use the BEARS training package, which includes virtual reality games designed to improve hearing skills, for 3 months alongside their usual care, or they continue with their usual care alone.

1 baseline visit before starting and ongoing self-administered training; usual care appointments as per routine

Follow-up

Duration - 9 months

Participants are followed for 9 months after the treatment period with hearing assessments and questionnaires completed through a combination of online and in-person appointments.

Regular follow-up visits including online and in-person assessments over the 9 months

Trial Site Locations

Total: 13 locations

1

The Midlands Hearing Implant Programme (Children's Service)

Birmingham, Birmingham, United Kingdom, B4 7ET

Active, Not Recruiting

2

Yorkshire Auditory Implant Service

Bradford, Bradford, United Kingdom, BD9 6RJ

Actively Recruiting

3

Emmeline Centre for Hearing Implants

Cambridge, Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

4

Scottish Cochlear Implant Programme

Kilmarnock, Kilmarnock, United Kingdom, KA2 0BE

Actively Recruiting

5

St Thomas' Hospital Hearing Implant Centre

London, London, United Kingdom, SE1 7EH

Actively Recruiting

6

St George's Auditory Implant Service

London, London, United Kingdom, SW17 OQT

Actively Recruiting

7

Auditory Implants: Royal National ENT and Eastman Dental Hospitals

London, London, United Kingdom, WC1E 6DG

Actively Recruiting

8

Great Ormond Street Cochlear Implant Programme

London, London, United Kingdom, WC1N 3JH

Actively Recruiting

9

The Richard Ramsden Centre for Hearing Implants

Manchester, Manchester, United Kingdom, M13 9WL

Actively Recruiting

10

North East Regional Cochlear Implant Programme

Middlesbrough, Middlesborough, United Kingdom, TS4 3BW

Actively Recruiting

11

Nottingham Auditory Implant Programme

Nottingham, Nottingham, United Kingdom, NG1 5DU

Actively Recruiting

12

Oxford Auditory Implant Centre

Oxford, Oxford, United Kingdom, OX3 9DU

Actively Recruiting

13

University of Southampton Auditory Implant Service

Southampton, Southampton, United Kingdom, SO17 1BJ

Actively Recruiting

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Research Team

D

Debi Vickers, PhD

L

Liz Arram, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Involving Children and Teenagers With Bilateral Cochlear Implants in the Design of the BEARS (Both EARS) Virtual Reality Training Suite Improves Personalization.

Deborah Vickers, Marina Salorio-Corbetto, Sandra Driver...

https://pubmed.ncbi.nlm.nih.gov/34870270