Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation
NCT04063748 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2023-02-17
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
Conditions
- Hearing Disability
Interventions
- BEHAVIORAL
-
Audiological rehabilitation
Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise
- BEHAVIORAL
-
Placebo Rehabilitation
CI-users: Placebo, tablet-based take-home psychophysical tasks, reading (non auditory)
- BEHAVIORAL
-
Passive Control
No intervention in the passive control group for HA-users.
Sponsors & Collaborators
-
KU Leuven
collaborator OTHER -
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Astrid van Wieringen · KU Leuven
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-01-01
- Primary Completion
- 2022-08-28
- Completion
- 2024-04-30
Countries
- Belgium
Study Locations
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