BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants

Официальное название

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

Обзор

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.

Подробное описание

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:

1. Receiving the BEARS training package to use for 3-months alongside usual care 2. Continue with usual care

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.

Participants and clinicians can also consent to qualitative or process evaluation interviews, which are BEARS sub-studies

Вмешательства

• Другое Both EARS training package (BEARS)
  The BEARS training package comprises of three games addressing different hearing functions: speech-in-noise perception, music listening and sound-source localisation. Each game is based on an audio-visual task performed through a virtual-reality interface. Players are guided through on-screen visual prompts to support the gameplay with feedback given on their performance and progress through levels of increasing difficulty. The BEARS training package design allows for the training to be self-adm
• Другое Usual Care
  This is an annual review appointment with the patient and their clinician. This could be face-to-face, virtual video consultation, questionnaire, or be cochlear remote care checks. As a minimum this review will check the following: Microphone covers changed, Reported or recorded device use, all external and internal equipment working (known through no reported or recorded degradation in hearing ability). During the appointment, the clinician would establish if there were any concerns regarding t

Первичные конечные точки

• Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome [Срок оценки: Three months]

Вторичные конечные точки (12)

• SSiN-VA test outcome [Срок оценки: Twelve months]
• SSiN-VA test outcome [Срок оценки: Three and Twelve Months]
• Spatial Adaptive Sentence List (Sp-ASL) test outcomes [Срок оценки: Three and Twelve Months]
• British Picture Vocabulary Scale (BPVS) test outcome [Срок оценки: Twelve Months]
• Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome [Срок оценки: Three and Twelve Months]
• Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome [Срок оценки: Three and Twelve Months]
• Health Economic outcomes [Срок оценки: Twelve Months]
• SSiN-VA test outcome [Срок оценки: Three and Twelve Months]
• SSiN-VA test outcome [Срок оценки: Three and Twelve Months]
• SSiN-VA test outcome [Срок оценки: Three and Twelve Months]
• SSiN-VA test outcome [Срок оценки: Three and Twelve Months]
• Spatial Adaptive Sentence List (Sp-ASL) test outcomes [Срок оценки: Three and Twelve Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 13 центров

• The Midlands Hearing Implant Programme (Children's Service) — Birmingham
• Yorkshire Auditory Implant Service — Bradford
• Emmeline Centre for Hearing Implants — Cambridge
• Scottish Cochlear Implant Programme — Kilmarnock
• St Thomas' Hospital Hearing Implant Centre — London
• St George's Auditory Implant Service — London
• Auditory Implants: Royal National ENT and Eastman Dental Hospitals — London
• Great Ormond Street Cochlear Implant Programme — London
• … и ещё 5 центров

Публикации

• Vickers D, Salorio-Corbetto M, Driver S, Rocca C, Levtov Y, Sum K, Parmar B, Dritsakis G, Albanell Flores J, Jiang D, Mahon M, Early F, Van Zalk N, Picinali L. Involving Children and Teenagers With Bilateral Cochlear Implants in the Design of the BEARS (Both EARS) Virtual Reality Training Suite Improves Personalization. Front Digit Health. 2021 Nov 12;3:759723. doi: 10.3389/fdgth.2021.759723. eCol PMID 34870270
• Salorio-Corbetto M, Williges B, Lamping W, Picinali L, Vickers D. Evaluating Spatial Hearing Using a Dual-Task Approach in a Virtual-Acoustics Environment. Front Neurosci. 2022 Mar 8;16:787153. doi: 10.3389/fnins.2022.787153. eCollection 2022. PMID 35350560

Идентификаторы

NCT: NCT05808543 · 319903

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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