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.
Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.
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)
Participant has stable programmes (defined as no longer using progressive programmes to work through).
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.
Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.
Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
Parallel
Both EARS training package (BEARS)
Other interventionThe 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
Other interventionThis 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.
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.
SSiN-VA test outcome
Speech-in-noise perception score (% correct of the overall task) at twelve months accounting for the baseline score.
SSiN-VA test outcome
Relative localisation score (% correct) at three months and at twelve months accounting for the baseline score.
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).
British Picture Vocabulary Scale (BPVS) test outcome
Difference between arms in vocabulary age at twelve months, accounting for baseline vocabulary age
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
University of Cambridge
Collaborator
University College, London
Collaborator
Imperial College London
Collaborator
University of Nottingham
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
University of Southampton
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
