Hearing Disability
Conditions
Keywords
auditory rehabilitation
Brief summary
It is believed that persons with hearing impairment benefit from auditory rehabilitation (AR), i.e. regular assessment and training of their listening skills. However, the efficacy of auditory rehabilitation has not been investigated before. In Leuven (Belgium) an e-health app has been developed that enables performance assessment, listening skills training, and counselling for persons with hearing impairment. Currently, an RCT is prepared to evaluate the different modules in persons with hearing impairment. The experimental group will receive auditory rehabilitation training modules, and a control group will either receive training tasks that are NOT believed to transfer to improved listening skills or will not receive any training (passive control). 1. Do participants improve on the trained tasks in the LUISTER AR scheme and does this improvement transfer to an improvement in speech perception in noise (primary outcome), executive functioning and/or quality of life (secondary outcomes)? 2. Does training with the LUISTER AR scheme provide more benefit on primary and secondary outcomes than a placebo program (active control group) or no training (passive control group)? 3. Can improvement in speech in noise perception, obtained with the LUISTER AR scheme, be consolidated until 6 months after training has stopped? 4. Are certain user-specific or training-specific aspects correlated to improvement on task-specific learning as well as near- and far transfer
Detailed description
Goals of the study: To determine an optimal, personalized AR scheme (considering age, degree of HI) and possible interacting factors (e.g., training time, type of errors) To investigate transfer of auditory and auditory-cognitive training to listening skills in everyday life To develop evidence-based guidelines for clinical AR A study to assess the efficacy in CI users will start with baseline assessment (speech in noise understanding, LIST sentences and cognitive tests (executive functioning, important for listening skills). This will be followed by 8 weeks of training, an intermediate assessment moment, again 8 weeks of training, and a final evaluation moment. After 6 months follow-up evaluation to investigate retention. This study is comprised of an active training group and an active control group. A study to assess the efficacy in HA users will start with baseline assessment (speech in noise understanding, LIST sentences and cognitive tests (executive functioning, important for listening skills). This will be followed by 6 weeks of training, an intermediate (online) assessment moment, again 6 weeks of training, and a final evaluation moment.
Interventions
BEHAVIORALAudiological rehabilitation
Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise
BEHAVIORALPlacebo Rehabilitation
CI-users: Placebo, tablet-based take-home psychophysical tasks, reading (non auditory)
BEHAVIORALPassive Control
No intervention in the passive control group for HA-users.
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participant does not know whether (s)he receives treatment or placebo. The investigator and the outcomes assessor are blind to this information too. The care provide (speech therapist) would know after communication with the participant. In case of the HA-study, participants either receive an intervention or do not receive an intervention. Therefore, they cannot be masked.
Intervention model description
Participants are assigned to either the test or the placebo group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* hearing impaired * sufficient knowledge of the Dutch language
Exclusion criteria
* cognitively impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech in noise intelligibility | Change at 16 wks compared to baseline | LIST sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST, (van Wieringen & Wouters, 2008)) was specifically designed for speech perception in noise assessment in CI users. The test has a 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 LUISTER AR scheme will be an improvement of 2dB on speech discrimination in noise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Executive functioning: task switching | 16 weeks, + 6 months | Trail Making A-B |
| Executive functioning updating | 16 weeks, + 6 months | letter memory task |
| Executive functioning inhibition | 16 weeks, + 6 months | Stroop test |
| Self-reported measure | 0 and 16 weeks, + 6 months | Nijmegen CI Questionnaire (NCIQ): 5-points scale assesses communication and quality. of life in persons with a cochlear implant. There are 6 subdomains, ranging from 0 (low) to 100 (high). Subdomains are evaluated by adding together the scores of each questions per subdomain and dividing this by the number of completed items per subdomain. A total score is reported. |
| Transfer of change in speech in noise intelligibility | Change at 6 months post intervention compared to primary outcome | LIST sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST, (van Wieringen & Wouters, 2008)) was specifically designed for speech perception in noise assessment in CI users. The test has a 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. |
| Fluid intelligence | 0 weeks, for baseline | Matrix reasoning (WAIS test) |
Countries
Belgium
Outcome results
None listed