- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05766020
Training Listening Skills With the Inclusion of Cognitive Control (TRAILS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgium, 3001
- KU Leuven, Experimental ORL, Dept Neurosciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate training group
Participants in this group will train immediately for 4 weeks.
Afterwards, they will not train for the 8 remaining weeks.
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Auditory skills with the inclusion of cognitive control.
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Experimental: Delayed Training Group
Participants in this group will receive delayed training after 4 weeks of no training.
|
Auditory skills with the inclusion of cognitive control.
|
Experimental: Active control group
Participants in this group will perform an active control for 4 weeks, followed by 4 weeks of training.
|
Auditory skills with the inclusion of cognitive control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 weeks
|
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.
|
4 weeks
|
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.
|
8 weeks
|
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.
|
12 weeks
|
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.
|
0 weeks
|
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.
|
4 weeks
|
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 weeks
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 weeks
|
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.
|
4 weeks
|
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.
|
8 weeks
|
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.
|
12 weeks
|
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.
|
0 weeks
|
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.
|
4 weeks
|
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 weeks
|
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.
|
12 weeks
|
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.
|
0 weeks
|
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.
|
4 weeks
|
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.
|
8 weeks
|
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.
|
12 weeks
|
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.
|
0 weeks
|
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.
|
4 weeks
|
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.
|
0 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Astrid van Wieringen, PhD, KU Leuven
Publications and helpful links
General Publications
- 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.
- 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.
- Noble W. Hearing, hearing impairment, and the audible world: a theoretical essay. Audiology. 1983;22(4):325-38. doi: 10.3109/00206098309072793.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S63310
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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