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NCT Number: NCT05766020

Training Listening Skills With the Inclusion of Cognitive Control

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hearing Disability

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven, Experimental ORL, Dept Neurosciences

Leuven, Vlaams Brabant, 3001, Belgium

About this study

Goals of the study:

  • Investigate transfer of listening skills to non-trained listening.
  • To develop evidence-based guidelines for clinical audiological rehabilitation.
  • Investigate if the inclusion of cognitive control frees up cognitive resources to use for another concurrent task.
  • Inform about retention following listening training

All participants will be assessed 4 times, with a 4-week interval in between. Participants in the first arm will perform the training during the first two weeks. 4 weeks after training ended and 8 weeks after training ended, retention of training gains will be assessed. Participants in the second arm will perform the delayed training. This is to control for procedural learning effects. After 4 weeks they will start training for 4 weeks. After training retention of training gains will be assessed after 4 weeks. The third arm will start with active control training (listening to stories) for 4 weeks, followed by training for 4 weeks. After these 8 weeks, retention was measured 4 weeks later. Participants are randomly allocated to a group. The efficacy of training will be determined with a within-subject design (i.e. baseline session outcomes will be compared to the final session outcomes of the randomized control trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

(all groups):

  • Severely visually impaired
  • Motorically impaired
  • Cognitively impaired

Treatment and study plan

Listen training

Behavioral

Auditory skills with the inclusion of cognitive control.

Primary outcomes

  1. Speech in noise intelligibility

    Time frame: 0 weeks

    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.

  2. Speech in noise intelligibility

    Time frame: 4 weeks

    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.

  3. Speech in noise intelligibility

    Time frame: 8 weeks

    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. Speech in noise intelligibility

    Time frame: 12 weeks

    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.

  5. phoneme identification in noise

    Time frame: 0 weeks

    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.

  6. phoneme identification in noise

    Time frame: 4 weeks

    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.

  7. phoneme identification in noise

    Time frame: 8 weeks

    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. phoneme identification in noise

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. The temporal modulation Transfer function

    Time frame: 0 weeks

    With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.

  2. The temporal modulation Transfer function

    Time frame: 4 weeks

    With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.

  3. The temporal modulation Transfer function

    Time frame: 8 weeks

    With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.

  4. The temporal modulation Transfer function

    Time frame: 12 weeks

    With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.

  5. Dual-task listening postural control

    Time frame: 0 weeks

    This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.

  6. Dual-task listening postural control

    Time frame: 4 weeks

    This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.

  7. Dual-task listening postural control

    Time frame: 8 weeks

    This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.

  8. Dual-task listening postural control

    Time frame: 12 weeks

    This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.

  9. Stroop task

    Time frame: 0 weeks

    The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.

  10. Stroop task

    Time frame: 4 weeks

    The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.

  11. Stroop task

    Time frame: 8 weeks

    The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.

  12. Stroop task

    Time frame: 12 weeks

    The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.

  13. EAS (Effort Assessment Scale)

    Time frame: 0 weeks

    EAS is a validated scale to measure listening effort. The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.

  14. EAS (Effort Assessment Scale)

    Time frame: 4 weeks

    EAS is a validated scale to measure listening effort. The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.

  15. SSQ12 (Speech, Spatial and Qualities of Hearing Scale)

    Time frame: 0 weeks

    The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.

  16. SSQ12 (Speech, Spatial and Qualities of Hearing Scale)

    Time frame: 4 weeks

    The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: TRAILS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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