Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

NCT04063748 | Unknown

• 1 other identifier: S59845
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Can improvement in speech in noise perception, obtained with the LUISTER AR scheme, be consolidated until 6 months after training has stopped?
4. 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

Keywords

auditory rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Executive functioning inhibition

  16 weeks, + 6 months

• Executive functioning: task switching

  16 weeks, + 6 months

• Executive functioning updating

  16 weeks, + 6 months

• Fluid intelligence

  0 weeks, for baseline

• Self-reported measure

  0 and 16 weeks, + 6 months

Study Arms (3)

Experimental

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).

Behavioral: Audiological rehabilitation

Placebo

OTHER

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).

Behavioral: Placebo Rehabilitation

Passive Control

PLACEBO COMPARATOR

HA users: Participants do not receive an intervention.

Behavioral: Passive Control

Interventions

Audiological rehabilitation BEHAVIORAL

Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise

Also known as: LUISTER

Experimental

Placebo Rehabilitation BEHAVIORAL

CI-users: Placebo, tablet-based take-home psychophysical tasks, reading (non auditory)

Placebo

Passive Control BEHAVIORAL

No intervention in the passive control group for HA-users.

Passive Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hearing impaired
• sufficient knowledge of the Dutch language

You may not qualify if:

• cognitively impaired

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

KU Leuven, Experimental ORL, Dept Neurosciences

Leuven, Vlaams Brabant, 3001, Belgium

Location

Related Publications (2)

• 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.

  PMID: 36534665 DERIVED

• 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.

  PMID: 35732012 DERIVED

Study Officials

• Astrid van Wieringen

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant does not know whether (s)he receives treatment or placebo. The investigator and the outcomes assessor are blind to this information too. The care provide (speech therapist) would know after communication with the participant. In case of the HA-study, participants either receive an intervention or do not receive an intervention. Therefore, they cannot be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to either the test or the placebo group.

Study Record Dates

• First Submitted: August 10, 2019
• First Posted: August 21, 2019
• Study Start: January 1, 2019
• Primary Completion: August 28, 2022
• Study Completion: April 30, 2024
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)