Clinical trial NCT05766020: Training Listening Skills With the Inclusion of Cognitive Control
Official title: Training Listening Skills With the Inclusion of Cognitive Control
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Disability
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speech in noise intelligibility
timeFrame: 0 weeks
measure: Speech in noise intelligibility
timeFrame: 4 weeks
measure: Speech in noise intelligibility
timeFrame: 8 weeks
measure: Speech in noise intelligibility
timeFrame: 12 weeks
measure: phoneme identification in noise
timeFrame: 0 weeks
measure: phoneme identification in noise
timeFrame: 4 weeks
measure: phoneme identification in noise
timeFrame: 8 weeks
measure: phoneme identification in noise
timeFrame: 12 weeks
Secondary outcomes:
measure: The temporal modulation Transfer function
timeFrame: 0 weeks
measure: The temporal modulation Transfer function
timeFrame: 4 weeks
measure: The temporal modulation Transfer function
timeFrame: 8 weeks
measure: The temporal modulation Transfer function
timeFrame: 12 weeks
measure: Dual-task listening postural control
timeFrame: 0 weeks
measure: Dual-task listening postural control
timeFrame: 4 weeks
measure: Dual-task listening postural control
timeFrame: 8 weeks
measure: Dual-task listening postural control
timeFrame: 12 weeks
measure: Stroop task
timeFrame: 0 weeks
measure: Stroop task
timeFrame: 4 weeks
measure: Stroop task
timeFrame: 8 weeks
measure: Stroop task
timeFrame: 12 weeks
measure: EAS (Effort Assessment Scale)
timeFrame: 0 weeks
measure: EAS (Effort Assessment Scale)
timeFrame: 4 weeks
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: 0 weeks
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven, Experimental ORL, Dept Neurosciences
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Astrid van Wieringen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Noble W. Hearing, hearing impairment, and the audible world: a theoretical essay. Audiology. 1983;22(4):325-38. doi: 10.3109/00206098309072793.
citation: 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.