Speech-in-Noise outcomes in older children and teenagers with bilateral cochlear implants Ear, Nose and Throat
Conditions
Interventions
Participants will be randomized using Sealed Envelope, which is an online software application.
Intervention: Both EARS training package (BEARS) and Usual Care:
BEARS is a compilation of virtual rea
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 02/12/2024: 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 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 full-time 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 Previous 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| SSiN-VA test outcomes: 1. Speech-in-noise perception score (% correct of the overall task), derived from the spatial speech in noise (SSiN-VA) test and measured at baseline and 12 months. 2. Relative localisation score (% correct), derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 3. Average reaction time (measure of listening effort) for word identification selections, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 4. Average reaction time (measure of listening effort) for location shift selection, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 5. Spatial index for word identification, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. 6. Spatial index for relative localisation, derived from the spatial speech in noise (SSiN-VA) test and measured at baseline, 3 months and 12 months. Spatial ASL test outcomes: 1. Speech reception threshold (for better ear, worse ear, and average of both), derived from the spatial adaptive sentence list (Sp-ASL) test and measured at baseline, 3 months and 12 months. 2. Spatial release from masking score (for better ear, worse ear, and average of both), derived from the spatial adaptive sentence list (Sp-ASL) test and measured at baseline, 3 months and 12 -months. British Picture Vocabulary Scale (c) test outcome: 1. Vocabulary age, derived from the British Picture Vocabulary Scale and measured at baseline and 12 months Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome: 1. Listening-related fatigue score, derived from the Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire and measured at baseline, 3 months and 12 months Health economic outcomes: The economic evaluation will calculate incremental cost per quality-adjusted life-year (QALY) gained | — |
Countries
England, United Kingdom
Contacts
Public ContactLiz Arram
Outcome results
None listed