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:
-
Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has:
- Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.
- 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)
-
Participant has stable programmes (defined as no longer using progressive programmes to work through).
-
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.
-
Participant is aged 8-16 years, inclusive.
Exclusion Criteria:
- Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
- Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.
- Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
- Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
- Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.
- Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming.
- Participant is refusing to consent to trial activities/protocol.
- Participant is awaiting reimplantation following device failure or infection.
- 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).
- Participant is a fulltime boarder at a boarding school
- Participant has unresolvable issues found in device checks that render one of the implants unusable.
- Participant is a female that is pregnant.
- 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)
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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