A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 384
- 主要终点
- Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
研究概览
简要总结
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.
详细描述
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 are children.
Two implants are supposed to provide better access to sound, but it is challenging to interpret and integrate what is heard from both sides. Our 'Living with cochlear implants' Patient and Public Involvement group reported that everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise. They reported that current rehabilitation techniques are not engaging, or appropriate to their lifestyles.
To address these issues, we have developed a set of virtual reality games called BEARS (Both EARS). BEARS trains sound localisation and listening in noise. These are skills required in everyday listening.
The aim of this 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 study will be carried out in clinical cochlear implant departments in National Health Service or University hospitals.
Participants will be randomly allocated into one of two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 has had any changes to the programmes of either cochlear implant within the last four weeks.
- •Participant has had a change of cochlear implant processor model or upgrade within the last four weeks.
- •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.
研究组 & 干预措施
Both EARS training package (BEARS) and Usual Care
BEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: A Head Mounted Display Device or an iPad with headphones.
干预措施: Both EARS training package (BEARS) (Other)
Both EARS training package (BEARS) and Usual Care
BEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: A Head Mounted Display Device or an iPad with headphones.
干预措施: Usual Care (Other)
Usual Care
Usual care describes the routine rehabilitation received by participants via their implant centre.
干预措施: Usual Care (Other)
结局指标
主要结局
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
时间窗: Three months
The Primary outcome for the BEARS trial is the difference between the intervention groups in speech-in-noise perception score (% correct overall task) at 3 months, accounting for the participant's baseline score. This is derived from the spatial speech in noise (SSiN-VA) test.
次要结局
- SSiN-VA test outcome(Three and Twelve Months)
- Spatial Adaptive Sentence List (Sp-ASL) test outcomes(Three and Twelve Months)
- British Picture Vocabulary Scale (BPVS) test outcome(Twelve Months)
- Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome(Three and Twelve Months)
- Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome(Three and Twelve Months)
- Health Economic outcomes(Twelve Months)
- SSiN-VA test outcome(Twelve months)