Assistant for LIstening and Communication Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Speech in noise intelligibility
研究概览
简要总结
As we get older, our hearing deteriorates and an age-related hearing loss can develop. Having a hearing loss can make it more difficult for people to understand conversations. Hearing aids can help in these situations, but difficulties often remain in more challenging situations, for example, when a conversation is being held in a group or when background noise is present. These difficulties are often not only related to the hearing loss but also to how these sounds are processed in the brain. Auditory rehabilitation is believed to help persons with a hearing impairment train their listening and communication skills. Auditory rehabilitation includes sensory management to enhance auditory function; knowledge and skills to improve the outcome; perceptual training and counselling. For this reason, the ALICE app was developed. The ALICE app contains monitoring tests, listening training exercises and counselling for persons with a hearing impairment.
In the current study, the ALICE app will be evaluated by persons with a hearing impairment. The experimental group will use the ALICE app in addition to the standard of care (hearing aid or cochlear implant) while the control group will receive the standard of care. Listening and communication skills will be evaluated pre and post training by a speech perception test in noise and questionnaires.
详细描述
This study is set-up as a pre-market clinical investigation of a non-CE marked medical device. The main goal of the study is to measure the efficacy of the ALICE app (Assistant for Listening and Communication Enhancement), a newly developed software application that will function as an added service in the aural rehabilitation of persons with HI, by providing remote monitoring, training and follow-up.
We will evaluate the efficacy and the clinical validity of the ALICE-app by means of a randomized controlled trial (RCT) with three arms. The first arm of the RCT will be carried out with 180 experienced hearing aid and/or cochlear implant users. The second arm of the RCT will be carried out with 120 first time hearing aid users. The third arm of the RCT includes an evaluation of the French version of the ALICE app, which will be carried out in 120 experienced hearing aid users from the French-speaking part of Belgium (the Walloon Region and Brussels).The participants will be divided in two groups: one group receiving the standard of care (control group), and another group receiving the standard of care supplemented with the ALICE-app.
All participants in the first and third arm will be assessed two times, at the beginning of the study and after 8 weeks of training (or without for the control group). The participants in the second arm will be assessed three times, at the beginning of the study, during the trial period with hearing aids and at the end of their trial period. The trial period with hearing aids takes on average 4-6 weeks. For the assessment we will use standardized clinical measures. These measures include a speech perception test in noise and validated questionnaires. The efficacy of ALICE will be determined in a within-subject design, i.e., baseline session outcomes will be compared to the final session outcomes of the randomized control trial, with a repeated measures ANOVA (α = 0.05).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Speech in noise intelligibility
时间窗: During the appointment at the end of the hearing aid trial period
BLU (Brugge-Leuven-Utrecht list) words presented in speech-weighted noise. Participants are required to repeat words in noise. The Brugge-Leuven-Utrecht list (BLU, ((Bosman, Woutes \& Damman), 1994)) is a validated speech test during which Dutch words are provided in quiet or in noise. Each list contains 10 2-sylable words.
次要结局
- IOI-HA (International Outcome Inventory for Hearing Aids)(During the appointment at the end of the hearing aid trial period)
- SSQ12 (Speech, Spatial and Qualities of Hearing Scale)(During the appointment at the end of the hearing aid trial period)
- COSI (Client Oriented Scale of Improvement)(During the appointment at the end of the hearing aid trial period)
- CAS (Communication and Acceptance Scale)(During the appointment at the end of the hearing aid trial period)
- EAS (Effort Assessment Scale)(After 8 weeks of training with the ALICE app during the final appointment)
- The ALICE-specific Questionnaire(During the appointment at the end of the hearing aid trial period)