Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

Study Overview
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Brief Summary
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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

Detailed Description
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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. A study to assess the efficacy in HA 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 6 weeks of training, an intermediate (online) assessment moment, again 6 weeks of training, and a final evaluation moment.

Official Title
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Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

Conditions
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Hearing Disability

Intervention / Treatment
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* Behavioral: Audiological rehabilitation
* Behavioral: Placebo Rehabilitation
* Behavioral: Passive Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hearing impaired sufficient knowledge of the Dutch language Exclusion Criteria: cognitively impaired

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to either the test or the placebo group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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). | Behavioral: Audiological rehabilitation<br>* Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise<br>* Other names: LUISTER;|
| Other: Placebo<br>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). | Behavioral: Placebo Rehabilitation<br>* CI-users: Placebo, tablet-based take-home psychophysical tasks, reading (non auditory)<br>|
| Placebo Comparator: Passive Control<br>HA users: Participants do not receive an intervention. | Behavioral: Passive Control<br>* No intervention in the passive control group for HA-users.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech in noise intelligibility | 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. | Change at 16 wks compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive functioning inhibition | Stroop test | 16 weeks, + 6 months | 
| Executive functioning: task switching | Trail Making A-B | 16 weeks, + 6 months | 
| Executive functioning updating | letter memory task | 16 weeks, + 6 months | 
| Fluid intelligence | Matrix reasoning (WAIS test) | 0 weeks, for baseline | 
| Self-reported measure | Nijmegen CI Questionnaire (NCIQ): 5-points scale assesses communication and quality. of life in persons with a cochlear implant. There are 6 subdomains, ranging from 0 (low) to 100 (high). Subdomains are evaluated by adding together the scores of each questions per subdomain and dividing this by the number of completed items per subdomain. A total score is reported. | 0 and 16 weeks, + 6 months | 
| Self-reported measure | Coping: Utrechtse Coping Lijst: A validated questionnaire based on a 4-point scale: assesses coping strategies in daily life. There are 7 subscales and 1 total score. Scale varies between 1 (low) and 4 (high). | 0 weeks, for baseline | 
| Transfer of change in speech in noise intelligibility | 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. | Change at 6 months post intervention compared to primary outcome | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auditory rehabilitation