BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilater… (NCT05808543) | Clinical Trial Compass
RecruitingNot Applicable
BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
United Kingdom272 participantsStarted 2023-07-27
Plain-language 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 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. They will be followed up for the next 9-months through online and in-person appointments.
Who can participate
Age range8 Years – 16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
. 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.