Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation
NCT ID: NCT04063748
Last Updated: 2023-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-01-01
2024-04-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
In case of the HA-study, participants either receive an intervention or do not receive an intervention. Therefore, they cannot be masked.
Study Groups
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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).
Audiological rehabilitation
Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise
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).
Placebo Rehabilitation
CI-users: Placebo, tablet-based take-home psychophysical tasks, reading (non auditory)
Passive Control
HA users: Participants do not receive an intervention.
Passive Control
No intervention in the passive control group for HA-users.
Interventions
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Audiological rehabilitation
Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise
Placebo Rehabilitation
CI-users: Placebo, tablet-based take-home psychophysical tasks, reading (non auditory)
Passive Control
No intervention in the passive control group for HA-users.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* sufficient knowledge of the Dutch language
Exclusion Criteria
18 Years
80 Years
ALL
Yes
Sponsors
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KU Leuven
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Astrid Van Wieringen, PhD
Professor
Principal Investigators
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Astrid van Wieringen
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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KU Leuven, Experimental ORL, Dept Neurosciences
Leuven, Vlaams Brabant, Belgium
Countries
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References
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Magits S, Boon E, De Meyere L, Dierckx A, Vermaete E, Francart T, Verhaert N, Wouters J, van Wieringen A. Comparing the Outcomes of a Personalized Versus Nonpersonalized Home-Based Auditory Training Program for Cochlear Implant Users. Ear Hear. 2023 May-Jun 01;44(3):477-493. doi: 10.1097/AUD.0000000000001295. Epub 2022 Oct 29.
van Wieringen A, Wouters J. Lilliput: speech perception in speech-weighted noise and in quiet in young children. Int J Audiol. 2023 Aug;62(8):747-755. doi: 10.1080/14992027.2022.2086491. Epub 2022 Jun 22.
Related Links
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Other Identifiers
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S59845
Identifier Type: -
Identifier Source: org_study_id
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