NCT04063748: LUISTER

Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

Status unknown NA Last updated 17 February 2023

What this trial tests

NA trial testing Audiological rehabilitation in Hearing Disability in 90 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
28 August 2022

30 April 2024

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	90
Start date	1 January 2019
Primary completion	28 August 2022
Estimated completion	30 April 2024
Sites	1 location across Belgium

Drugs / interventions tested

• Audiological rehabilitation
• Placebo Rehabilitation
• Passive Control

Conditions studied

• Hearing Disability — all drugs for Hearing Disability →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 18 to 80, any sex, with Hearing Disability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Home-Based Speech Perception Monitoring for Clinical Use With Cochlear Implant Users.
   van Wieringen A, Magits S, Francart T, Wouters J. · · 2021 · cited 10× · PMID 34916902 · DOI 10.3389/fnins.2021.773427
2. Effectiveness of Auditory Training in Experienced Hearing-Aid Users, and an Exploration of Their Health-Related Quality of Life and Coping Strategies.
   Van Wilderode M, Vermaete E, Francart T, Wouters J, et al · · 2023 · cited 9× · PMID 37709273 · DOI 10.1177/23312165231198380
3. Lilliput: speech perception in speech-weighted noise and in quiet in young children.
   van Wieringen A, Wouters J. · · 2023 · cited 6× · PMID 35732012 · DOI 10.1080/14992027.2022.2086491