Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

Hearing Disability Clinical Trial

— LUISTER  

Official title:

Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04063748
• Other study ID #: S59845
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 30, 2024
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• hearing impaired

• sufficient knowledge of the Dutch language

Exclusion Criteria:

• cognitively impaired

Related Conditions & MeSH terms

• Hearing Disability

Intervention

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
• 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.

Locations

Country	Name	City	State
Belgium	KU Leuven, Experimental ORL, Dept Neurosciences	Leuven	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Executive functioning inhibition	Stroop test	16 weeks, + 6 months
Secondary	Executive functioning: task switching	Trail Making A-B	16 weeks, + 6 months
Secondary	Executive functioning updating	letter memory task	16 weeks, + 6 months
Secondary	Fluid intelligence	Matrix reasoning (WAIS test)	0 weeks, for baseline
Secondary	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
Secondary	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
Secondary	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

External Links

•   Brief description of research project