BEARS

• Research type

  Research Study

• Full title

  A phase III, unblinded, multi-centre randomised controlled trial to evaluate whether 3 months of spatial-listening training delivered via the Both EARS training package (BEARS) in addition to Usual Care compared to Usual Care alone improves hearing abilities and quality of life and is cost effective in older children and teenagers with bilateral cochlear implants.

• IRAS ID

  319903

• Contact name

  Dan Jiang

• Contact email

  dan.jiang@gstt.nhs.uk

• Sponsor organisation

  Guy's and St Thomas' NHS Foundation Trust

• Duration of Study in the UK

  2 years, 10 months, 31 days

• Research summary

  Deafness is the most frequent human sensory deficit. Cochlear implantation is the primary intervention. Currently 4340 people have bilateral Cochlear Implants (CIs) in the UK, 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 CIs’ PPI 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, unfit 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 project is based on the brain learning theory in which the brain can extract sound information from the implants through training.

  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 in young people between 8-16 years old (inclusive) with two CIs. The study will be carried out in clinical CI departments in NHS or University hospitals.

  Eligible participants will have two CIs with stable settings (no longer working through programmes).

  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

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  23/YH/0046

• Date of REC Opinion

  10 Mar 2023

• REC opinion

  Favourable Opinion