Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation
- Conditions
- Hearing Disability
- Interventions
- Behavioral: Placebo RehabilitationBehavioral: Passive ControlBehavioral: Audiological rehabilitation
- Registration Number
- NCT04063748
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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).
1. 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)?
2. 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)?
3. Can improvement in speech in noise perception, obtained with the LUISTER AR scheme, be consolidated until 6 months after training has stopped?
4. Are certain user-specific or training-specific aspects correlated to improvement on task-specific learning as well as near- and far transfer
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- hearing impaired
- sufficient knowledge of the Dutch language
- cognitively impaired
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Rehabilitation 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). Passive Control Passive Control HA users: Participants do not receive an intervention. Experimental Audiological rehabilitation 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).
- Primary Outcome Measures
Name Time Method Speech in noise intelligibility 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.
- Secondary Outcome Measures
Name Time Method Executive functioning: task switching 16 weeks, + 6 months Trail Making A-B
Executive functioning updating 16 weeks, + 6 months letter memory task
Self-reported measure 0 weeks, for baseline 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).
Executive functioning inhibition 16 weeks, + 6 months Stroop test
Transfer of change in speech in noise intelligibility Change at 6 months post intervention compared to primary outcome 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.Fluid intelligence 0 weeks, for baseline Matrix reasoning (WAIS test)
Trial Locations
- Locations (1)
KU Leuven, Experimental ORL, Dept Neurosciences
🇧🇪Leuven, Vlaams Brabant, Belgium