RecruitingNAINTERVENTIONAL

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

This study is for young people aged 8 to 16 who have two cochlear implants. It's called the BEARS trial and it's looking at a new type of training package. This package uses virtual reality games to help improve listening skills, especially in noisy situations. Researchers want to find out if using these games for three months, alongside their usual care, helps children and teenagers hear better, understand speech more easily when there's background noise, and feel better about their hearing overall. They also want to see if it reduces how much effort they need to put into listening. Participants will be compared to a group receiving only usual care, and everyone will be followed for a year.

At a glance

Status

Recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

272

Start

27 Jul 2023

Estimated completion

31 Oct 2026

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

What is this study about?

Imagine you have two cochlear implants. While they're great for helping you hear, sometimes it can still be tricky to make sense of sounds coming from both sides, especially when there's a lot of background noise. Many young people and their families have told us that everyday conversations can be tiring because it takes a lot of effort to understand what's being said.

That's where the BEARS (Both EARS) training package comes in. We've developed a set of fun virtual reality games designed to help improve key listening skills, like figuring out where sounds are coming from and understanding speech in noisy environments. These are skills that are really important for daily life.

This study aims to discover if using these BEARS games for three months, along with regular care, can make a real difference. We're hoping it will help young people aged 8 to 16 with two cochlear implants to hear better in noisy places, improve their communication skills, boost their vocabulary, and generally improve their quality of life, all while making listening less tiring. We'll be comparing these results to a group who only receive their usual care.

Key takeaways

New study for 8-16 year olds with two cochlear implants.
Looks at a virtual reality game called BEARS to improve listening.
Aims to help hear better in noisy places and reduce listening effort.
Compares BEARS training plus usual care to usual care alone.
Participation lasts about one year with online and in-person checks.
Could improve daily communication and quality of life for participants.

Who may be eligible?

This study is looking for young people aged between 8 and 16 years old who have two cochlear implants. You should be using both of your implants regularly (at least six hours a day for a month) and your implant settings should be stable, meaning your specialist isn't making big regular changes to them anymore. If you received your first implant for hearing loss from birth, you should have had at least one implant before you were three years old.

However, this study might not be right for you if you or your parents don't understand English well enough for the tests, or if you have a learning disability that would make it hard to understand the study tasks. Also, if you have other health conditions or are involved in other medical studies that might affect your hearing, or if you're waiting for an implant to be replaced, this study might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 8 and 16 years old?
Do you have two cochlear implants?
Do you use both your implants for at least 6 hours a day?
Are your cochlear implant settings stable (not changing frequently)?
Can you understand and speak English well enough for tests?
Are you able to participate in games and answer questions without difficulty from other conditions?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have some hearing tests and fill out questionnaires to get a baseline measurement. Then, you'll be randomly put into one of two groups. One group will use the BEARS virtual reality training games for three months, alongside their usual care. The other group will continue with their usual care only. Throughout this three-month period, you'll be asked to complete the training or just continue with your regular appointments. After the initial three months, we'll follow up with you for the next nine months. These follow-up appointments will happen both online and in person, checking on your hearing and how you're doing. The total duration of your participation, including the initial assessments, the three-month intervention, and the nine-month follow-up, will be about one year.

Potential risks and benefits

Taking part in this study may offer benefits such as potentially improving your listening skills, especially in noisy environments, and possibly enhancing your overall quality of life related to hearing. There are no known physical risks associated with the BEARS virtual reality games or the assessments, beyond the time commitment required. As with any study, there's always a chance that the new training might not work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Midlands Hearing Implant Programme (Children's Service)
Verified postcode
Birmingham, United Kingdom· Active not recruiting
Yorkshire Auditory Implant Service
Verified postcode
Bradford, United Kingdom· Recruiting
Emmeline Centre for Hearing Implants
Verified postcode
Cambridge, United Kingdom· Recruiting
Scottish Cochlear Implant Programme
Verified postcode
Kilmarnock, United Kingdom· Recruiting
St Thomas' Hospital Hearing Implant Centre
Verified postcode
London, United Kingdom· Recruiting
St George's Auditory Implant Service
Verified postcode
London, United Kingdom· Recruiting
Auditory Implants: Royal National ENT and Eastman Dental Hospitals
Verified postcode
London, United Kingdom· Recruiting
Great Ormond Street Cochlear Implant Programme
Verified postcode
London, United Kingdom· Recruiting
The Richard Ramsden Centre for Hearing Implants
Verified postcode
Manchester, United Kingdom· Recruiting
North East Regional Cochlear Implant Programme
Verified postcode
Middlesbrough, United Kingdom· Recruiting
Nottingham Auditory Implant Programme
Verified postcode
Nottingham, United Kingdom· Recruiting
Oxford Auditory Implant Centre
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What are cochlear implants?

Cochlear implants are small electronic devices that can help people who are very hard of hearing or deaf to hear. They work differently from hearing aids by directly stimulating the hearing nerve.

What is the BEARS training package?

BEARS stands for Both EARS. It's a series of fun virtual reality games designed to help young people improve their skills in locating sounds and understanding speech when there's background noise.

Will I have to stop my usual care if I join?

No, you will continue with your usual cochlear implant care throughout the study. The BEARS training package is an addition to your normal care.

How long will I be in the study?

If you take part, you'll be in the study for about one year in total. This includes an initial assessment, three months of either BEARS training or usual care, and then nine months of follow-up.

Is this study safe?

Yes, this study is designed to be safe. The assessments are standard hearing tests, and the BEARS games are virtual reality and are not expected to have any physical risks.

How to find out more

Debi Vickers, PhD

dav1000@medschl.cam.ac.uk 01223 760683 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.