Both EARS training package (BEARS) to maximise hearing abilities in older children and teenagers with bilateral cochlear implants
- Conditions
- Ear, Nose and ThroatSpeech-in-Noise outcomes in older children and teenagers with bilateral cochlear implants
- Registration Number
- ISRCTN92454702
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 384
1. Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has:
1.1. Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant =36 months of age
1.2. Progressive or acquired severe/profound bilateral sensorineural hearing loss (no age at implant restrictions for these patients)
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 500 Hz-4 kHz) 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
*(a bilateral CI user is defined as a patient who uses both CI processors for a minimum of 6 hours per day over a month)
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 intervention and/or outcome assessment
4. Participant has an audiological profile impacting ability to participate in 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 has had any changes to the programmes of either CI within the last 4 weeks
10. Participant has had a change of CI processor model or upgrade within the last 4 weeks
11. 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)
12. Participant is a full-time boarder at a boarding school
13. Participant has unresolvable issues found in device checks that render one of the implants unusable
14. Participant is a female that is pregnant
15. Participant has a diagnosis of epilepsy or history of seizures of any kind
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Speech-in-noise perception score (% correct overall task), derived from the spatial speech in noise (SSiN-VA) test and measured at baseline and 3 months
- Secondary Outcome Measures
Name Time Method