Clinical trial NCT05808543: BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss
Deafness
Hearing Impaired Children and Adolescents
Keywords: Cochlear Implant
Virtual Reality
Children
Teenagers
Deaf
Bilateral
Training
Rehabilitation
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
name: University College, London
name: Imperial College London
name: University of Nottingham
name: Cambridge University Hospitals NHS Foundation Trust
name: University of Southampton
name: National Institute for Health Research, United Kingdom
First posted: 2023-04-11
Enrollment: 384
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

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

Eligibility criteria: 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 has had any changes to the programmes of either cochlear implant within the last four weeks.
10. Participant has had a change of cochlear implant processor model or upgrade within the last four weeks.
11. 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).
12. Participant is a fulltime boarder at a boarding school
13. Participant has unresolvable issues found in device checks that render one of the implants unusable.
14. Participant is a female that is pregnant.
15. Participant has a diagnosis of epilepsy or history of seizures of any kind.

Primary outcomes:
measure: Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
timeFrame: Three months
Secondary outcomes:
measure: SSiN-VA test outcome
timeFrame: Twelve months
measure: SSiN-VA test outcome
timeFrame: Three and Twelve Months
measure: Spatial Adaptive Sentence List (Sp-ASL) test outcomes
timeFrame: Three and Twelve Months
measure: British Picture Vocabulary Scale (BPVS) test outcome
timeFrame: Twelve Months
measure: Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome
timeFrame: Three and Twelve Months
measure: Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome
timeFrame: Three and Twelve Months
measure: Health Economic outcomes
timeFrame: Twelve Months
measure: SSiN-VA test outcome
timeFrame: Three and Twelve Months
measure: SSiN-VA test outcome
timeFrame: Three and Twelve Months
measure: SSiN-VA test outcome
timeFrame: Three and Twelve Months
measure: SSiN-VA test outcome
timeFrame: Three and Twelve Months
measure: Spatial Adaptive Sentence List (Sp-ASL) test outcomes
timeFrame: Three and Twelve Months
Other outcomes:
measure: Age effects
timeFrame: Twelve Months
measure: Retention of training effects
timeFrame: Three and Twelve Months
measure: Impact of degree of balance between ears
timeFrame: Three and Twelve Months
Locations:
Study officials:
References:
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.
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.