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Hearing DisabilityLUISTERNCT04063748

Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

A study testing Audiological rehabilitation in people with Hearing Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Hearing Disability
What is being tested?
Audiological rehabilitation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteBelgium
Study dates
1 Jan 2019to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • hearing impaired
  • sufficient knowledge of the Dutch language

Who cannot join

  • cognitively impaired

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • KU Leuven, Experimental ORL, Dept Neurosciences

    Leuven, Vlaams Brabant, 3001

Other trials in Belgium

About this study

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
Read the 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.

Being tested
Audiological rehabilitation, Placebo Rehabilitation, Passive Control
Keywords
auditory rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Audiological rehabilitationBehavioural

    Also called LUISTER

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

  • Placebo RehabilitationBehavioural

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

  • Passive ControlBehavioural

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

Study groups in NCT04063748
Study groupRoleWhat they receive
ExperimentalExperimentalParticipants 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).
Receives: Behavioral: Audiological rehabilitation
PlaceboOtherCI-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).
Receives: Behavioral: Placebo Rehabilitation
Passive ControlPlacebo comparatorHA users: Participants do not receive an intervention.
Receives: Behavioral: Passive Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change at 16 wks compared to baseline

Secondary outcomes (7)

  1. Executive functioning inhibition

    Stroop test

    Measured: 16 weeks, + 6 months

  2. Executive functioning: task switching

    Trail Making A-B

    Measured: 16 weeks, + 6 months

  3. Executive functioning updating

    letter memory task

    Measured: 16 weeks, + 6 months

  4. Fluid intelligence

    Matrix reasoning (WAIS test)

    Measured: 0 weeks, for baseline

  5. 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.

    Measured: 0 and 16 weeks, + 6 months

  6. 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).

    Measured: 0 weeks, for baseline

  7. 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.

    Measured: Change at 6 months post intervention compared to primary outcome

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2019
  2. Study start1 Jan 2019
  3. Primary completion28 Aug 2022
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to either the test or the placebo group.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04063748
Sponsor's protocol ID
S59845
Acronym
LUISTER
Status last verified
Feb 2023
First submitted
10 Aug 2019
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36534665

  • 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.

    PubMed 35732012

Questions about this trial

What is this clinical trial studying?

A study testing Audiological rehabilitation in people with Hearing Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech in noise intelligibility (time frame: Change at 16 wks compared to baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04063748, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.

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