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Both EARS training package (BEARS) to maximise hearing abilities in teenage bilateral cochlear implant users
NIHR Programme Grants for Applied Research. Host organisation Guy's and St Thomas' NHS Foundation Trust. PI Dr Debi Vickers; UCL PALS Co-I's Dr Merle Mahon; Prof Stuart Rosen. Teenagers using bilateral cochlear implants are not fulfilling their potential due to problems with poor sound localisation and associated speech-in-noise perception. These deficits negatively affect speech and language development, education, and social well-being. The lack of protocols for fitting bilateral cochlear implants, ecologically-valid outcome measures and training methods to improve spatial skills contribute to these listening difficulties. Recent evidence shows that spatial hearing abilities develop over time with bilateral experience. A large body of research demonstrates that sound localisation can improve with training, underpinned by plasticity-driven changes in the auditory pathways for both children and adults. We have developed a package of Virtual-Reality games (BEARS, Both EARS) to train teenagers with bilateral cochlear implants in sound localisation and spatial-listening skills. The aim is to confirm whether the use of BEARS leads to improvements in everyday hearing for teenage bilateral cochlear implant users. Our objectives are to determine whether the use of BEARS: (i) improves speech-in-noise perception in spatial environments; (ii) improves quality of life (QoL); (iii) is cost effective; (iv) improves perceived benefits of everyday listening. During the development phase (years 1 and 2), BEARS will be optimised using participatory design methods with a Patient and Public Involvement Group (PPI) as co-creators. Another PPI group will inform the content of a qualitative topic guide for the clinical trial and define the Normalised Process Theory framework for use in a Process Evaluation. A clinicians’ group will manualise the Usual Care Pathways. Additionally, age-appropriate normal-hearing ranges will be determined for the spatial speech-in-noise measures. An existing bilateral hearing specific QoL measure and a tool for capturing healthcare resource usage will be adapted for use with teenage bilateral cochlear implantees, for use in the clinical trial. In the clinical trial phase (years 3, 4 and 5), 384 bilateral cochlear implantees aged 11-16 years will be recruited from 9 clinics. They will be randomly allocated to one of two groups: BEARS or Usual Care. The BEARS group will receive 3 months of spatial training. Both groups will attend clinics for assessments at baseline, 3 and 12 months, and an online QoL evaluation at 6 months. Qualitative interviews will occur following the trial. Outcomes to be compared include spatial speech-in-noise measures, QoL, resource use and perceived benefits. Assessors will be blind to group allocation. A process evaluation will run alongside the trial to evaluate the quality and mechanistic changes of the intervention. A cost-utility analysis using trial data will be performed. Outputs and deliverables will be made immediately available to clinicians. Findings will be communicated to the public through organised events supported by patient groups and charities. It should take 12 to 18 months for full awareness. Positive outcomes will lead to readily available computer-based portable training tools for bilateral cochlear implantees. It would transform current practice from outpatient-based rehabilitation to self-administered training. Objective and subjective outcome measures tailored to teenagers can replace current measures, to better evaluate everyday hearing experiences.
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