Training Listening Skills With the Inclusion of Cognitive Control

Hearing Disability Clinical Trial

— TRAILS  

Official title:

Training Listening Skills With the Inclusion of Cognitive Control

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05766020
• Other study ID #: S63310
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Disability

Intervention

Behavioral:
• Listen training
Auditory skills with the inclusion of cognitive control.

Locations

Country	Name	City	State
Belgium	KU Leuven, Experimental ORL, Dept Neurosciences	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The temporal modulation Transfer function	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
Secondary	The temporal modulation Transfer function	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
Secondary	The temporal modulation Transfer function	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
Secondary	The temporal modulation Transfer function	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
Secondary	Dual-task listening postural control	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
Secondary	Dual-task listening postural control	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
Secondary	Dual-task listening postural control	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
Secondary	Dual-task listening postural control	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
Secondary	Stroop task	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
Secondary	Stroop task	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
Secondary	Stroop task	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
Secondary	Stroop task	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
Secondary	EAS (Effort Assessment Scale)	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
Secondary	EAS (Effort Assessment Scale)	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
Secondary	SSQ12 (Speech, Spatial and Qualities of Hearing Scale)	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
Secondary	SSQ12 (Speech, Spatial and Qualities of Hearing Scale)	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