Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

NCT04063748 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-02-17

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063748 on ClinicalTrials.gov