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

Primary Purpose

Hearing Loss, Sensorineural, Hearing Loss, Deafness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Both EARS training package (BEARS)
Usual Care
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Cochlear Implant, Virtual Reality, Children, Teenagers, Deaf, Bilateral, Training, Rehabilitation

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has: Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age. 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) Participant has stable programmes (defined as no longer using progressive programmes to work through). 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. Participant is aged 8-16 years, inclusive. Exclusion Criteria: Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions. Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment. Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming. Participant is refusing to consent to trial activities/protocol. Participant is awaiting reimplantation following device failure or infection. Participant has had any changes to the programmes of either cochlear implant within the last four weeks. Participant has had a change of cochlear implant processor model or upgrade within the last four weeks. 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). Participant is a fulltime boarder at a boarding school Participant has unresolvable issues found in device checks that render one of the implants unusable. Participant is a female that is pregnant. Participant has a diagnosis of epilepsy or history of seizures of any kind.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Both EARS training package (BEARS) and Usual Care

    Usual Care

    Arm Description

    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.

    Usual care describes the routine rehabilitation received by participants via their implant centre.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    SSiN-VA test outcome
    Speech-in-noise perception score (% correct of the overall task) at twelve months accounting for the baseline score.
    SSiN-VA test outcome
    Relative localisation score (% correct) at three months and at twelve months accounting for the baseline score.
    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).
    British Picture Vocabulary Scale (BPVS) test outcome
    Difference between arms in vocabulary age at twelve months, accounting for baseline vocabulary age
    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.
    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.
    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.
    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.
    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.
    SSiN-VA test outcome
    Spatial index for word identification at three months and at twelve months accounting for the baseline score.
    SSiN-VA test outcome
    Spatial index for relative localisation at three months and at twelve months accounting for the baseline score.
    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).

    Full Information

    First Posted
    March 17, 2023
    Last Updated
    March 30, 2023
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    University of Cambridge, University College, London, Imperial College London, University of Nottingham, Cambridge University Hospitals NHS Foundation Trust, University of Southampton, National Institute for Health Research, United Kingdom
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05808543
    Brief Title
    BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
    Acronym
    BEARS
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    University of Cambridge, University College, London, Imperial College London, University of Nottingham, Cambridge University Hospitals NHS Foundation Trust, University of Southampton, National Institute for Health Research, United Kingdom

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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: Receiving the BEARS training package to use for 3-months alongside usual care 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Sensorineural, Hearing Loss, Deafness, Hearing Impaired Children and Adolescents
    Keywords
    Cochlear Implant, Virtual Reality, Children, Teenagers, Deaf, Bilateral, Training, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomised on a 1:1 ratio to either the BEARS or usual care intervention arm. The trial will be unblinded.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    384 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Both EARS training package (BEARS) and Usual Care
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm Description
    Usual care describes the routine rehabilitation received by participants via their implant centre.
    Intervention Type
    Other
    Intervention Name(s)
    Both EARS training package (BEARS)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
    Description
    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.
    Time Frame
    Three months
    Secondary Outcome Measure Information:
    Title
    SSiN-VA test outcome
    Description
    Speech-in-noise perception score (% correct of the overall task) at twelve months accounting for the baseline score.
    Time Frame
    Twelve months
    Title
    SSiN-VA test outcome
    Description
    Relative localisation score (% correct) at three months and at twelve months accounting for the baseline score.
    Time Frame
    Three and Twelve Months
    Title
    Spatial Adaptive Sentence List (Sp-ASL) test outcomes
    Description
    Speech reception threshold at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).
    Time Frame
    Three and Twelve Months
    Title
    British Picture Vocabulary Scale (BPVS) test outcome
    Description
    Difference between arms in vocabulary age at twelve months, accounting for baseline vocabulary age
    Time Frame
    Twelve Months
    Title
    Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome
    Description
    Difference between arms in listening-related fatigue score at three and 12 months, accounting for baseline.
    Time Frame
    Three and Twelve Months
    Title
    Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome
    Description
    Difference between arms in SSQ scores at three and 12 months, accounting for baseline.
    Time Frame
    Three and Twelve Months
    Title
    Health Economic outcomes
    Description
    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.
    Time Frame
    Twelve Months
    Title
    SSiN-VA test outcome
    Description
    Average reaction time (measure of listening effort) for word identification selections at three months and at twelve months accounting for the baseline score.
    Time Frame
    Three and Twelve Months
    Title
    SSiN-VA test outcome
    Description
    Average reaction time (measure of listening effort) for location shift selection at three months, and at twelve months accounting for the baseline score.
    Time Frame
    Three and Twelve Months
    Title
    SSiN-VA test outcome
    Description
    Spatial index for word identification at three months and at twelve months accounting for the baseline score.
    Time Frame
    Three and Twelve Months
    Title
    SSiN-VA test outcome
    Description
    Spatial index for relative localisation at three months and at twelve months accounting for the baseline score.
    Time Frame
    Three and Twelve Months
    Title
    Spatial Adaptive Sentence List (Sp-ASL) test outcomes
    Description
    Spatial release from masking score at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).
    Time Frame
    Three and Twelve Months
    Other Pre-specified Outcome Measures:
    Title
    Age effects
    Description
    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.
    Time Frame
    Twelve Months
    Title
    Retention of training effects
    Description
    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.
    Time Frame
    Three and Twelve Months
    Title
    Impact of degree of balance between ears
    Description
    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.
    Time Frame
    Three and Twelve Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has: Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age. 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) Participant has stable programmes (defined as no longer using progressive programmes to work through). 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. Participant is aged 8-16 years, inclusive. Exclusion Criteria: Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions. Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment. Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming. Participant is refusing to consent to trial activities/protocol. Participant is awaiting reimplantation following device failure or infection. Participant has had any changes to the programmes of either cochlear implant within the last four weeks. Participant has had a change of cochlear implant processor model or upgrade within the last four weeks. 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). Participant is a fulltime boarder at a boarding school Participant has unresolvable issues found in device checks that render one of the implants unusable. Participant is a female that is pregnant. Participant has a diagnosis of epilepsy or history of seizures of any kind.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Debi Vickers, PhD
    Phone
    01223 760683
    Email
    dav1000@medschl.cam.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liz Arram, MSc
    Email
    cctu.bears@ucl.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    First year of the trial opening
    IPD Sharing Access Criteria
    Open access
    Citations:
    PubMed Identifier
    34870270
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    35350560
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://www.guysandstthomasbrc.nihr.ac.uk/microsites/bears/our-team/
    Description
    BEARS website

    Learn more about this trial

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

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