Status:

RECRUITING

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

Lead Sponsor:

Guy's and St Thomas' NHS Foundation Trust

Collaborating Sponsors:

University of Cambridge

University College, London

Conditions:

Hearing Loss, Sensorineural

Hearing Loss

Eligibility:

All Genders

8-16 years

Phase:

NA

Brief 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 receiv...

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...

Eligibility Criteria

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.

Key Trial Info

Start Date :

July 27 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2026

Estimated Enrollment :

272 Patients enrolled

Trial Details

Trial ID

NCT05808543

Start Date

July 27 2023

End Date

October 31 2026

Last Update

April 1 2026

Active Locations (13)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (13 locations)

1

The Midlands Hearing Implant Programme (Children's Service)

Birmingham, Birmingham, United Kingdom, B4 7ET

2

Yorkshire Auditory Implant Service

Bradford, Bradford, United Kingdom, BD9 6RJ

3

Emmeline Centre for Hearing Implants

Cambridge, Cambridge, United Kingdom, CB2 0QQ

4

Scottish Cochlear Implant Programme

Kilmarnock, Kilmarnock, United Kingdom, KA2 0BE