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New treatment option for Hearing Loss, Sensorineural
Official title BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
ClinicalTrials.gov ID: NCT05808543
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 16
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- Participant is aged 8-16 years, inclusive.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Birmingham, United Kingdom
- Bradford, Bradford, United Kingdom
- Cambridge, Cambridge, United Kingdom
- Kilmarnock, Kilmarnock, United Kingdom
- London, London, United Kingdom
- Manchester, Manchester, United Kingdom
- Middlesbrough, Middlesborough, United Kingdom
- Nottingham, Nottingham, United Kingdom
- Oxford, Oxford, United Kingdom
- Southampton, Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Birmingham, United Kingdom; Bradford, Bradford, United Kingdom; Cambridge, Cambridge, United Kingdom; Kilmarnock, Kilmarnock, United Kingdom; London, London, United Kingdom; Manchester, Manchester, United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.