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

Not Applicable

Not yet recruiting

• Conditions: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Impaired Children and Adolescents
• Interventions: Other: Both EARS training package (BEARS); Other: Usual Care

• Registration Number: NCT05808543
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study Start: 2023-04
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11
• Primary Completion: 2025-02
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 384

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Both EARS training package (BEARS) and Usual Care	Both EARS training package (BEARS)	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	Usual Care	Usual care describes the routine rehabilitation received by participants via their implant centre.
Both EARS training package (BEARS) and Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome	Three months	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

Name	Time	Method
SSiN-VA test outcome	Three and Twelve Months	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	Three and Twelve Months	Spatial release from masking score 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	Twelve Months	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	Three and Twelve Months	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	Three and Twelve Months	Difference between arms in SSQ scores at three and 12 months, accounting for baseline.
Health Economic outcomes	Twelve Months	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.