Clinical trial NCT04063748: Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation
Official title: Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Disability
Keywords: auditory rehabilitation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2019-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either the test or the placebo group.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* hearing impaired
* sufficient knowledge of the Dutch language

Exclusion Criteria:

* cognitively impaired

Primary outcomes:
measure: Speech in noise intelligibility
timeFrame: Change at 16 wks compared to baseline
Secondary outcomes:
measure: Executive functioning inhibition
timeFrame: 16 weeks, + 6 months
measure: Executive functioning: task switching
timeFrame: 16 weeks, + 6 months
measure: Executive functioning updating
timeFrame: 16 weeks, + 6 months
measure: Fluid intelligence
timeFrame: 0 weeks, for baseline
measure: Self-reported measure
timeFrame: 0 and 16 weeks, + 6 months
measure: Self-reported measure
timeFrame: 0 weeks, for baseline
measure: Transfer of change in speech in noise intelligibility
timeFrame: Change at 6 months post intervention compared to primary outcome
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven, Experimental ORL, Dept Neurosciences
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Astrid van Wieringen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.