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

Hearing Loss Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05808543
• Other study ID #: 319903
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Debi Vickers, PhD
• Phone: 01223 760683
• Email: dav1000[@]medschl.cam.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

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

References & Publications (2)

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. — View 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 (B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	SSiN-VA test outcome	Speech-in-noise perception score (% correct of the overall task) at twelve months accounting for the baseline score.	Twelve months
Secondary	SSiN-VA test outcome	Relative localisation score (% correct) at three months and at twelve months accounting for the baseline score.	Three and Twelve Months
Secondary	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
Secondary	British Picture Vocabulary Scale (BPVS) test outcome	Difference between arms in vocabulary age at twelve months, accounting for baseline vocabulary age	Twelve Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BEARS website