Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Speech in noise intelligibility
研究概览
简要总结
It is believed that persons with hearing impairment benefit from auditory rehabilitation (AR), i.e. regular assessment and training of their listening skills. However, the efficacy of auditory rehabilitation has not been investigated before. In Leuven (Belgium) an e-health app has been developed that enables performance assessment, listening skills training, and counselling for persons with hearing impairment. Currently, an RCT is prepared to evaluate the different modules in persons with hearing impairment. The experimental group will receive auditory rehabilitation training modules, and a control group will either receive training tasks that are NOT believed to transfer to improved listening skills or will not receive any training (passive control).
- Do participants improve on the trained tasks in the LUISTER AR scheme and does this improvement transfer to an improvement in speech perception in noise (primary outcome), executive functioning and/or quality of life (secondary outcomes)?
- Does training with the LUISTER AR scheme provide more benefit on primary and secondary outcomes than a placebo program (active control group) or no training (passive control group)?
- Can improvement in speech in noise perception, obtained with the LUISTER AR scheme, be consolidated until 6 months after training has stopped?
- Are certain user-specific or training-specific aspects correlated to improvement on task-specific learning as well as near- and far transfer
详细描述
Goals of the study:
To determine an optimal, personalized AR scheme (considering age, degree of HI) and possible interacting factors (e.g., training time, type of errors)
To investigate transfer of auditory and auditory-cognitive training to listening skills in everyday life
To develop evidence-based guidelines for clinical AR
A study to assess the efficacy in CI users will start with baseline assessment (speech in noise understanding, LIST sentences and cognitive tests (executive functioning, important for listening skills). This will be followed by 8 weeks of training, an intermediate assessment moment, again 8 weeks of training, and a final evaluation moment. After 6 months follow-up evaluation to investigate retention. This study is comprised of an active training group and an active control group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant does not know whether (s)he receives treatment or placebo. The investigator and the outcomes assessor are blind to this information too. The care provide (speech therapist) would know after communication with the participant.
In case of the HA-study, participants either receive an intervention or do not receive an intervention. Therefore, they cannot be masked.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •hearing impaired
- •sufficient knowledge of the Dutch language
排除标准
- •cognitively impaired
研究组 & 干预措施
Experimental
Participants are asked to train (at least) 5 times a week during 15 - 20 mins. The first 4 sessions are training sessions, the fifth session is an in-training test session (DTT and phoneme discrimination).
干预措施: Audiological rehabilitation (Behavioral)
Placebo
CI-users: Participants are asked to train (at least) 5 times a week during 15 - 20 mins. The first 4 sessions are training sessions, and the fifth session is an in-training test session (DTT and phoneme discrimination).
干预措施: Placebo Rehabilitation (Behavioral)
Passive Control
HA users: Participants do not receive an intervention.
干预措施: Passive Control (Behavioral)
结局指标
主要结局
Speech in noise intelligibility
时间窗: Change at 16 wks compared to baseline
LIST sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST, (van Wieringen \& Wouters, 2008)) was specifically designed for speech perception in noise assessment in CI users. The test has a high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech. discrimination in noise. Therefore, the primary endpoint to validate the LUISTER AR scheme will be an improvement of 2dB on speech discrimination in noise.
次要结局
- Executive functioning: task switching(16 weeks, + 6 months)
- Executive functioning updating(16 weeks, + 6 months)
- Self-reported measure(0 weeks, for baseline)
- Executive functioning inhibition(16 weeks, + 6 months)
- Transfer of change in speech in noise intelligibility(Change at 6 months post intervention compared to primary outcome)
- Fluid intelligence(0 weeks, for baseline)
- Self-reported measure(0 and 16 weeks, + 6 months)
研究者
Astrid Van Wieringen, PhD
Professor
Universitaire Ziekenhuizen KU Leuven