ALICE: Assistant for LIstening and Communication Enhancement
Study Details
Study Description
Brief Summary
As we get older, our hearing deteriorates and an age-related hearing loss can develop. Having a hearing loss can make it more difficult for people to understand conversations. Hearing aids can help in these situations, but difficulties often remain in more challenging situations, for example, when a conversation is being held in a group or when background noise is present. These difficulties are often not only related to the hearing loss but also to how these sounds are processed in the brain. Auditory rehabilitation is believed to help persons with a hearing impairment train their listening and communication skills. Auditory rehabilitation includes sensory management to enhance auditory function; knowledge and skills to improve the outcome; perceptual training and counselling. For this reason, the ALICE app was developed. The ALICE app contains monitoring tests, listening training exercises and counselling for persons with a hearing impairment.
In the current study, the ALICE app will be evaluated by persons with a hearing impairment. The experimental group will use the ALICE app in addition to the standard of care (hearing aid or cochlear implant) while the control group will receive the standard of care. Listening and communication skills will be evaluated pre and post training by a speech perception test in noise and questionnaires.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALICE Clients participating in this arm are asked to train their listening and communication skills using the ALICE app on their personal smart device for 8 weeks. |
Behavioral: ALICE: Audiological rehabilitation
Persons who are randomised into this arm of the study will be asked to train their listening and communication skills using the ALICE app for 8 weeks.
Other Names:
|
| No Intervention: Control This arm will receive the standard of care given to the client. Persons with a moderate to profound hearing loss are provided with a hearing aid. Persons with a profound to severe HI are provided with a cochlear implant and concomitant rehabilitation. Most persons with a cochlear implant receive intensive rehabilitation during the first 6 months after their implantation. Afterwards, they mainly return for mapping of the device but not for listening training therapy. |
Outcome Measures
Primary Outcome Measures
- Speech in noise intelligibility [During the first appointment before using the ALICE app]
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, (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 ALICE app will be an improvement of 2dB on speech discrimination in noise.
- Speech in noise intelligibility [After 8 weeks of training with the ALICE app during the final appointment]
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, (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 ALICE app will be an improvement of 2dB on speech discrimination in noise.
Secondary Outcome Measures
- COSI (Client Oriented Scale of Improvement) [During the first appointment before using the ALICE app]
The COSI questionnaire is a validated clinical tool that can assist in measuring the impact of hearing aid fitting on a person's life and the benefit that is obtained after intervention (Dillon et al., 1997). Administering the COSI questionnaire is also part of the RIZIV application to receive a refund for hearing aids. The COSI questionnaire allows the audiologist to measure improvements in listening situations important for their client. Before fitting the hearing aids, together with their client, they list their client's needs/goals. After hearing aids have been fitted and the client has had time to experience the hearing aids, they evaluate the progression/satisfaction in these situations together with their client.
- COSI (Client Oriented Scale of Improvement) [After 8 weeks of training with the ALICE app during the final appointment]
The COSI questionnaire is a validated clinical tool that can assist in measuring the impact of hearing aid fitting on a person's life and the benefit that is obtained after intervention (Dillon et al., 1997). Administering the COSI questionnaire is also part of the RIZIV application to receive a refund for hearing aids. The COSI questionnaire allows the audiologist to measure improvements in listening situations important for their client. Before fitting the hearing aids, together with their client, they list their client's needs/goals. After hearing aids have been fitted and the client has had time to experience the hearing aids, they evaluate the progression/satisfaction in these situations together with their client.
- CAS (Communication and Acceptance Scale) [During the first appointment before using the ALICE app]
The CAS is a validated scale that consist of 18 items (Öberg et al., 2021). The CAS scale is a reliable instrument that can be used to measure the effect of a rehabilitation programme. Each question is scored on a 5-point Likert scale (completely agree to completely disagree). It was developed to detect clinical changes in "communication strategies and the emotional consequences, knowledge and acceptance of hearing loss". This questionnaire has been translated from Swedish to Dutch (and back translated to ensure correct translation).
- CAS (Communication and Acceptance Scale) [After 8 weeks of training with the ALICE app during the final appointment]
The CAS is a validated scale that consist of 18 items (Öberg et al., 2021). The CAS scale is a reliable instrument that can be used to measure the effect of a rehabilitation programme. Each question is scored on a 5-point Likert scale (completely agree to completely disagree). It was developed to detect clinical changes in "communication strategies and the emotional consequences, knowledge and acceptance of hearing loss". This questionnaire has been translated from Swedish to Dutch (and back translated to ensure correct translation).
- EAS (Effort Assessment Scale) [During the first appointment before using the ALICE app]
EAS is a validated scale to measure listening effort (Alhanbali et al., 2017). 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.
- EAS (Effort Assessment Scale) [After 8 weeks of training with the ALICE app during the final appointment]
EAS is a validated scale to measure listening effort (Alhanbali et al., 2017). 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.
- SSQ12 (Speech, Spatial and Qualities of Hearing Scale) [During the first appointment before using the ALICE app]
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. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.
- SSQ12 (Speech, Spatial and Qualities of Hearing Scale) [After 8 weeks of training with the ALICE app during the final appointment]
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. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clients with a hearing aid or cochlear implant.
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Clients with a hearing aid must have completed the hearing aid trial period and must have decided to purchase the hearing aid.
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Clients with a cochlear implant must have at least 6 months of experience with the implant.
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Clients who experience listening and communication difficulties.
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Clients may not have any experience with auditory training yet.
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Able to operate the training programme as an app on a mobile device/tablet (e.g. clients have a mobile device or table; clients have sufficient eyesight to see the exercises; clients must be able operate the programme).
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At least 18 years old.
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Dutch-speaking as all training material and counselling questions will be presented in Dutch.
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Clients need to have an Android smartphone and connection to internet
Exclusion Criteria:
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Visually impaired
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Motorically impaired
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Cognitively impaired
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KU Leuven, Experimental ORL, Dept Neurosciences | Leuven | Vlaams Brabant | Belgium | 3001 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
- KU Leuven
Investigators
- Principal Investigator: Astrid van Wieringen, PhD, KU Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S66285