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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants are asked to train (at least) 5 times a week during 15 - 20 mins. The first 4 sessions are training sessions, the fifth session is an in-training test session (DTT and phoneme discrimination). |
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| Placebo | Other | CI-users: Participants are asked to train (at least) 5 times a week during 15 - 20 mins. The first 4 sessions are training sessions, and the fifth session is an in-training test session (DTT and phoneme discrimination). |
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| Passive Control | Placebo Comparator | HA users: Participants do not receive an intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audiological rehabilitation | Behavioral | Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise |
| Measure | Description | Time Frame |
|---|---|---|
| Speech in noise intelligibility | 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. | Change at 16 wks compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Executive functioning inhibition | Stroop test | 16 weeks, + 6 months |
| Executive functioning: task switching | Trail Making A-B | 16 weeks, + 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid van Wieringen | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven, Experimental ORL, Dept Neurosciences | Leuven | Vlaams Brabant | 3001 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36534665 | Derived | Magits S, Boon E, De Meyere L, Dierckx A, Vermaete E, Francart T, Verhaert N, Wouters J, van Wieringen A. Comparing the Outcomes of a Personalized Versus Nonpersonalized Home-Based Auditory Training Program for Cochlear Implant Users. Ear Hear. 2023 May-Jun 01;44(3):477-493. doi: 10.1097/AUD.0000000000001295. Epub 2022 Oct 29. | |
| 35732012 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 27, 2023 | |
| Reset | Mar 27, 2024 | |
| Release | Apr 18, 2024 | |
| Reset | Sep 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 27, 2023 | Mar 27, 2024 | |||
| Apr 18, 2024 |
Participants are assigned to either the test or the placebo group.
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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.
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| Placebo Rehabilitation | Behavioral | CI-users: Placebo, tablet-based take-home psychophysical tasks, reading (non auditory) |
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| Passive Control | Behavioral | No intervention in the passive control group for HA-users. |
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| Executive functioning updating | letter memory task | 16 weeks, + 6 months |
| Fluid intelligence | Matrix reasoning (WAIS test) | 0 weeks, for baseline |
| Self-reported measure | 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. | 0 and 16 weeks, + 6 months |
| Self-reported measure | Coping: Utrechtse Coping Lijst: A validated questionnaire based on a 4-point scale: assesses coping strategies in daily life. There are 7 subscales and 1 total score. Scale varies between 1 (low) and 4 (high). | 0 weeks, for baseline |
| Transfer of change in speech in noise intelligibility | 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. | Change at 6 months post intervention compared to primary outcome |
| van Wieringen A, Wouters J. Lilliput: speech perception in speech-weighted noise and in quiet in young children. Int J Audiol. 2023 Aug;62(8):747-755. doi: 10.1080/14992027.2022.2086491. Epub 2022 Jun 22. |
| Sep 12, 2024 |