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

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Impaired Children and Adolescents
• Intervention / Treatment: Other: Both EARS training package (BEARS); Other: Usual Care

Detailed Description

Deafness is the most frequent human sensory deficit. Cochlear implantation is the primary intervention. Currently over 6000 people have bilateral cochlear implants in the United Kingdom, most of these are children.

Two implants are supposed to provide better access to sound, but it is challenging to interpret and integrate what is heard from both sides. Our 'Living with cochlear implants' Patient and Public Involvement group reported that everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise. They reported that current rehabilitation techniques are not engaging, or appropriate to their lifestyles.

To address these issues, we have developed a set of virtual reality games called BEARS (Both EARS). BEARS trains sound localisation and listening in noise. These are skills required in everyday listening.

The aim of this 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 study will be carried out in clinical cochlear implant departments in National Health Service or University hospitals.

Participants will be randomly allocated into one of two groups:

1. Receiving the BEARS training package to use for 3-months alongside usual care
2. Continue with usual care

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.

Participants and clinicians can also consent to qualitative or process evaluation interviews, which are BEARS sub-studies

• Study Type: Interventional
• Enrollment (Estimated): 272
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debi Vickers, PhD; Phone Number: 01223 760683; Email: dav1000@medschl.cam.ac.uk
• Study Contact Backup: Name: Liz Arram, MSc; Email: cctu.bears@ucl.ac.uk

Study Locations

• United Kingdom
  • Birmingham
    • Birmingham, Birmingham, United Kingdom, B4 7ET
      • Active, not recruiting
      • The Midlands Hearing Implant Programme (Children's Service)
  • Bradford
    • Bradford, Bradford, United Kingdom, BD9 6RJ
      • Recruiting
      • Yorkshire Auditory Implant Service
  • Cambridge
    • Cambridge, Cambridge, United Kingdom, CB2 0QQ
      • Recruiting
      • Emmeline Centre for Hearing Implants
  • Kilmarnock
    • Kilmarnock, Kilmarnock, United Kingdom, KA2 0BE
      • Recruiting
      • Scottish Cochlear Implant Programme
  • London
    • London, London, United Kingdom, SE1 7EH
      • Recruiting
      • St Thomas' Hospital Hearing Implant Centre
    • London, London, United Kingdom, SW17 OQT
      • Recruiting
      • St George's Auditory Implant Service
    • London, London, United Kingdom, WC1E 6DG
      • Recruiting
      • Auditory Implants: Royal National ENT and Eastman Dental Hospitals
    • London, London, United Kingdom, WC1N 3JH
      • Recruiting
      • Great Ormond Street Cochlear Implant Programme
  • Manchester
    • Manchester, Manchester, United Kingdom, M13 9WL
      • Recruiting
      • The Richard Ramsden Centre for Hearing Implants
  • Middlesborough
    • Middlesbrough, Middlesborough, United Kingdom, TS4 3BW
      • Recruiting
      • North East Regional Cochlear Implant Programme
  • Nottingham
    • Nottingham, Nottingham, United Kingdom, NG1 5DU
      • Recruiting
      • Nottingham Auditory Implant Programme
  • Oxford
    • Oxford, Oxford, United Kingdom, OX3 9DU
      • Recruiting
      • Oxford Auditory Implant Centre
  • Southampton
    • Southampton, Southampton, United Kingdom, SO17 1BJ
      • Recruiting
      • University of Southampton Auditory Implant Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has:

   1. Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.
   2. 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)
2. Participant has stable programmes (defined as no longer using progressive programmes to work through).
3. 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.
4. Participant is aged 8-16 years, inclusive.

Exclusion Criteria:

1. Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.
3. Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
4. Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.
6. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming.
7. Participant is refusing to consent to trial activities/protocol.
8. Participant is awaiting reimplantation following device failure or infection.
9. 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).
10. Participant is a fulltime boarder at a boarding school
11. Participant has unresolvable issues found in device checks that render one of the implants unusable.
12. Participant is a female that is pregnant.
13. Participant has a diagnosis of epilepsy or history of seizures of any kind.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Both EARS training package (BEARS) and Usual Care; BEARS 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.	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.
Active Comparator: Usual Care; Usual care describes the routine rehabilitation received by participants via their implant centre.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSiN-VA test outcome	Speech-in-noise perception score (% correct of the overall task) at twelve months accounting for the baseline score.	Twelve months
SSiN-VA test outcome	Relative localisation score (% correct) at three months and at twelve months accounting for the baseline score.	Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes	Speech reception threshold at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).	Three and Twelve Months
British Picture Vocabulary Scale (BPVS) test outcome	Difference between arms in vocabulary age at twelve months, accounting for baseline vocabulary age	Twelve Months
Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome	Difference between arms in listening-related fatigue score at three and 12 months, accounting for baseline.	Three and Twelve Months
Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome	Difference between arms in SSQ scores at three and 12 months, accounting for baseline.	Three and Twelve Months
Health Economic outcomes	The economic evaluation will calculate incremental cost per quality-adjusted life-year (QALY) gained by offering BEARS and usual care, compared to usual care, from an NHS, Personal Social Services (PSS) and Local Education Provider perspective over the twelve months of the trial.	Twelve Months
SSiN-VA test outcome	Average reaction time (measure of listening effort) for word identification selections at three months and at twelve months accounting for the baseline score.	Three and Twelve Months
SSiN-VA test outcome	Average reaction time (measure of listening effort) for location shift selection at three months, and at twelve months accounting for the baseline score.	Three and Twelve Months
SSiN-VA test outcome	Spatial index for word identification at three months and at twelve months accounting for the baseline score.	Three and Twelve Months
SSiN-VA test outcome	Spatial index for relative localisation at three months and at twelve months accounting for the baseline score.	Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes	Spatial release from masking score at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).	Three and Twelve Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age effects	No further data will be collected for the age effect analyses but the data regarding the trajectory of the children's speech-in-noise scores relative to normative age range for the speech measures will be assessed to determine if there is a difference in trajectory over time between the BEARS intervention and Usual Care groups.	Twelve Months
Retention of training effects	No further data will be collected for the retention effect analyses. It is considered best practice in training interventions to evaluate if the training effects remain after the intervention period has finished. For this analysis fixed effects of timepoint (baseline, 3, 6, 9 and 12 months) and group (BEARS intervention, Usual care) and random effect of participant will be used to understand the speech-in-noise outcomes.	Three and Twelve Months
Impact of degree of balance between ears	For this analysis, the balance app will be used to indicate the degree of symmetry across the two ears. The balance measurements at baseline, three months and 12 months will be used as an outcome to determine if there have been any changes in the balance between the ears over time.	Three and Twelve Months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: University of Nottingham; Imperial College London; University College, London; Cambridge University Hospitals NHS Foundation Trust; University of Southampton; University of Cambridge; National Institute for Health Research, United Kingdom

Publications and helpful links

General Publications

• 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.
• Salorio-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.

Helpful Links

• BEARS website

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Training; Children; Virtual Reality; Cochlear Implant; Teenagers; Deaf; Bilateral
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: 319903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: First year of the trial opening
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No