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

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Mar 30, 2023

Keywords

ClinConnect Summary

The BEARS clinical trial is studying a special training program designed to help young people aged 8 to 16 years with two cochlear implants improve their ability to hear and understand speech, especially in noisy environments. The trial will find out if this training, when added to their usual care, can help them hear better, expand their vocabulary, enhance their overall quality of life, and make listening less tiring. Participants will undergo hearing assessments and fill out questionnaires before starting the 3-month training, and they will have follow-up appointments over the next 9 months to track their progress.

To be eligible for the trial, participants must be between 8 and 16 years old and use two cochlear implants for at least six hours a day. They should have a stable hearing program and must not have any other serious health issues that could affect their ability to participate. It's important to note that the trial is not yet recruiting, so interested families will need to wait for enrollment to begin.

Gender

ALL

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.