BEARS directional-listening training to improve hearing in older children and teens with two cochlear implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial randomizes 8–16 year olds who use two cochlear implants to either 3 months of BEARS virtual-reality directional listening training plus usual care or to usual care alone. BEARS consists of game-like VR exercises that train sound localisation and listening in noise. Participants complete baseline hearing tests and questionnaires, then the 3-month intervention, followed by online and in-person follow-up visits over the next 9 months. The study is conducted at NHS and university cochlear implant centres in the UK with regular clinical oversight.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant is a simultaneous or sequential bilateral cochlear implant user\*, who either has:

   1. Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.
   2. 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)
2. Participant has stable programmes (defined as no longer using progressive programmes to work through).
3. 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.
4. Participant is aged 8-16 years, inclusive.

Exclusion Criteria:

1. Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.
3. Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
4. Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.
6. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming.
7. Participant is refusing to consent to trial activities/protocol.
8. Participant is awaiting reimplantation following device failure or infection.
9. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month).
10. Participant is a fulltime boarder at a boarding school
11. Participant has unresolvable issues found in device checks that render one of the implants unusable.
12. Participant is a female that is pregnant.
13. Participant has a diagnosis of epilepsy or history of seizures of any kind.

Where it's running

• Yorkshire Auditory Implant Service
  Bradford, Bradford, United Kingdom Recruiting
• Emmeline Centre for Hearing Implants
  Cambridge, Cambridge, United Kingdom Recruiting
• Scottish Cochlear Implant Programme
  Kilmarnock, Kilmarnock, United Kingdom Recruiting
• St Thomas' Hospital Hearing Implant Centre
  London, London, United Kingdom Recruiting
• St George's Auditory Implant Service
  London, London, United Kingdom Recruiting
• Auditory Implants: Royal National ENT and Eastman Dental Hospitals
  London, London, United Kingdom Recruiting

Study contacts

• Study coordinator: Debi Vickers, PhD
• Email: dav1000@medschl.cam.ac.uk
• Phone: 01223 760683

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.