NCT05766020

Brief Summary

Participating in spoken conversation constitutes a multitasking situation with concurrent demands on sensorimotor (auditory, postural) and cognitive functioning (memory, updating, task switching and inhibition). As aging affects multisensory integration and cognitive control, these higher-order processes are likely to put accumulating constraints on listening as adults grow older. By training listening skills (not solely auditory skills), the investigators aim at improving overall communication and quality of life. Moreover, the investigators aim at freeing up cognitive resources in the listen task: the better one gets at a certain domain specific task, the less one needs to draw from other resources and, the more resources are free for another concurrent task. The interdisciplinary approach will inform us about ideal audiological rehabilitation or intervention approaches. Pre-posttests comprise behavioral measures to evaluate listening skills and transfer towards non-trained measures. The training is tablet-based and can be performed at home.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

February 15, 2023

Last Update Submit

August 7, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Speech in noise intelligibility

    LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has 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 active training will be an improvement of 2dB on speech perception in noise.

    0 weeks

  • Speech in noise intelligibility

    LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has 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 active training will be an improvement of 2dB on speech perception in noise.

    4 weeks

  • Speech in noise intelligibility

    LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has 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 active training will be an improvement of 2dB on speech perception in noise.

    8 weeks

  • Speech in noise intelligibility

    LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has 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 active training will be an improvement of 2dB on speech perception in noise.

    12 weeks

  • phoneme identification in noise

    The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.

    0 weeks

  • phoneme identification in noise

    The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.

    4 weeks

  • phoneme identification in noise

    The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.

    8 weeks

  • phoneme identification in noise

    The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.

    12 weeks

Secondary Outcomes (16)

  • The temporal modulation Transfer function

    0 weeks

  • The temporal modulation Transfer function

    4 weeks

  • The temporal modulation Transfer function

    8 weeks

  • The temporal modulation Transfer function

    12 weeks

  • Dual-task listening postural control

    0 weeks

  • +11 more secondary outcomes

Study Arms (3)

Immediate training group

EXPERIMENTAL

Participants in this group will train immediately for 4 weeks. Afterwards, they will not train for the 8 remaining weeks.

Behavioral: Listen training

Delayed Training Group

EXPERIMENTAL

Participants in this group will receive delayed training after 4 weeks of no training.

Behavioral: Listen training

Active control group

EXPERIMENTAL

Participants in this group will perform an active control for 4 weeks, followed by 4 weeks of training.

Behavioral: Listen training

Interventions

Listen trainingBEHAVIORAL

Auditory skills with the inclusion of cognitive control.

Active control groupDelayed Training GroupImmediate training group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clients who experience listening and communication difficulties.
  • Clients must not undergo any audiological rehabilitation (auditory training/hearing aid fitting) during the study.
  • Able to operate the training programme as an app on a tablet (e.g. clients have sufficient eyesight to see the exercises; clients must be able to operate the programme).
  • At least 18 years old.
  • Dutch-speaking, as all training material and counselling questions will be presented in Dutch.

You may not qualify if:

  • Severely visually impaired
  • Motorically impaired
  • Cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven, Experimental ORL, Dept Neurosciences

Leuven, Vlaams Brabant, 3001, Belgium

Location

Related Publications (5)

  • van Wieringen A, Wouters J. Natural vowel and consonant recognition by Laura cochlear implantees. Ear Hear. 1999 Apr;20(2):89-103. doi: 10.1097/00003446-199904000-00001.

    PMID: 10229511BACKGROUND
  • van Wieringen A, Wouters J. LIST and LINT: sentences and numbers for quantifying speech understanding in severely impaired listeners for Flanders and the Netherlands. Int J Audiol. 2008 Jun;47(6):348-55. doi: 10.1080/14992020801895144.

    PMID: 18569107BACKGROUND
  • Noble W. Hearing, hearing impairment, and the audible world: a theoretical essay. Audiology. 1983;22(4):325-38. doi: 10.3109/00206098309072793.

    PMID: 6615338BACKGROUND
  • Alhanbali S, Dawes P, Lloyd S, Munro KJ. Self-Reported Listening-Related Effort and Fatigue in Hearing-Impaired Adults. Ear Hear. 2017 Jan/Feb;38(1):e39-e48. doi: 10.1097/AUD.0000000000000361.

    PMID: 27541332BACKGROUND
  • Van Wilderode M, Van Humbeeck N, Krampe RT, van Wieringen A. Enhancing Speech Perception in Noise Through Home-Based Competing Talker Training. Ear Hear. 2025 Jul-Aug 01;46(4):856-870. doi: 10.1097/AUD.0000000000001631. Epub 2025 Feb 10.

Study Officials

  • Astrid van Wieringen, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dr.

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 13, 2023

Study Start

April 3, 2023

Primary Completion

February 5, 2024

Study Completion

September 30, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations