NCT05808543

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Hearing Loss, Sensorineural
• Hearing Loss
• Deafness
• Hearing Impaired Children and Adolescents

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2023-07-27
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-04-11
• Last updated: 2026-04-01

Locations

13 sites across 1 country: United Kingdom