Hearing DisabilityALICENCT05329922
Assistant for LIstening and Communication Enhancement
A study testing ALICE: Audiological rehabilitation in people with Hearing Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Disability
- What is being tested?
- ALICE: Audiological rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2022to 14 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clients who are starting their hearing aid trial as a first time hearing aid user (N= 120). Which is more than necessary according to the power analysis (3.5.7).
- Clients who experience listening and communication difficulties
- 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).
- At least 18 years old.
- Dutch-speaking as all training material and counselling questions will be presented in Dutch
- Clients need to have an Android or iPhone smartphone and connection to internet
Who cannot join
- Visually impaired
- Motorically impaired
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
Belgium1 site
KU Leuven, Experimental ORL, Dept Neurosciences
Leuven, VLAAMS BRABANT, 3001
About this study
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.
Read the detailed description
This study is set-up as a pre-market clinical investigation of a non-CE marked medical device. The main goal of the study is to measure the efficacy of the ALICE app (Assistant for Listening and Communication Enhancement), a newly developed software application that will function as an added service in the aural rehabilitation of persons with HI, by providing remote monitoring, training and follow-up.
We will evaluate the efficacy and the clinical validity of the ALICE-app by means of a randomized controlled trial (RCT) with three arms. The first arm of the RCT will be carried out with 180 experienced hearing aid and/or cochlear implant users. The second arm of the RCT will be carried out with 120 first time hearing aid users. The third arm of the RCT includes an evaluation of the French version of the ALICE app, which will be carried out in 120 experienced hearing aid users from the French-speaking part of Belgium (the Walloon Region and Brussels).The participants will be divided in two groups: one group receiving the standard of care (control group), and another group receiving the standard of care supplemented with the ALICE-app.
All participants in the first and third arm will be assessed two times, at the beginning of the study and after 8 weeks of training (or without for the control group). The participants in the second arm will be assessed three times, at the beginning of the study, during the trial period with hearing aids and at the end of their trial period. The trial period with hearing aids takes on average 4-6 weeks. For the assessment we will use standardized clinical measures. These measures include a speech perception test in noise and validated questionnaires. The efficacy of ALICE will be determined in a within-subject design, i.e., baseline session outcomes will be compared to the final session outcomes of the randomized control trial, with a repeated measures ANOVA (α = 0.05).
- Conditions
- Hearing Disability
- Being tested
- ALICE: Audiological rehabilitation
- Keywords
- Auditory rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALICE: Audiological rehabilitationBehavioural
Also called Use of the ALICE app
Persons who are randomised into this arm of the study will be asked to train their listening and communication skills using the ALICE app.
| Study group | Role | What they receive |
|---|---|---|
| ALICE (experienced hearing aid/cochlear implant users) | Experimental | 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. Receives: Behavioral: ALICE: Audiological rehabilitation |
| Control (experienced hearing aid/cochlear implant users) | No intervention | 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. |
| ALICE (new hearing aid users) | Experimental | Clients participating in this arm are asked to train their listening and communication skills using the ALICE app on their personal smart device during the hearing aid trial period (4-6 weeks on average). Receives: Behavioral: ALICE: Audiological rehabilitation |
| Control (new hearing aid users) | No intervention | This arm will receive the standard of care given to the client during the hearing aid trial period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in noise intelligibility
Dutch: 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.
French: Listes disyllabiques de Lafon: disyllabic words presented in speech-weighted noise. Participants are required to repeat words in noise. The "Listes disyllabiques de Lafon" is a validated speech test during which French words are provided in quiet or in noise (Marie-Haps procedure).
Measured: During the first appointment before using the ALICE app
Speech in noise intelligibility
Dutch: 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.
French: Listes disyllabiques de Lafon: disyllabic words presented in speech-weighted noise. Participants are required to repeat words in noise. The "Listes disyllabiques de Lafon" is a validated speech test during which French words are provided in quiet or in noise (Marie-Haps procedure).
Measured: After 8 weeks of training with the ALICE app during the final appointment
Speech in noise intelligibility
BLU (Brugge-Leuven-Utrecht list) words presented in speech-weighted noise. Participants are required to repeat words in noise. The Brugge-Leuven-Utrecht list (BLU, ((Bosman, Woutes \& Damman), 1994)) is a validated speech test during which Dutch words are provided in quiet or in noise. Each list contains 10 2-sylable words.
Measured: During the first appointment before the hearing aid trial period
Speech in noise intelligibility
BLU (Brugge-Leuven-Utrecht list) words presented in speech-weighted noise. Participants are required to repeat words in noise. The Brugge-Leuven-Utrecht list (BLU, ((Bosman, Woutes \& Damman), 1994)) is a validated speech test during which Dutch words are provided in quiet or in noise. Each list contains 10 2-sylable words.
Measured: During an appointment 2 weeks into the hearing aid trial period
Speech in noise intelligibility
BLU (Brugge-Leuven-Utrecht list) words presented in speech-weighted noise. Participants are required to repeat words in noise. The Brugge-Leuven-Utrecht list (BLU, ((Bosman, Woutes \& Damman), 1994)) is a validated speech test during which Dutch words are provided in quiet or in noise. Each list contains 10 2-sylable words.
Measured: During the appointment at the end of the hearing aid trial period
Secondary outcomes (21)
COSI (Client Oriented Scale of Improvement)
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/INAMI 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.
Measured: During the first appointment before using the ALICE app
COSI (Client Oriented Scale of Improvement)
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.
Measured: During the first appointment before the hearing aid trial period
COSI (Client Oriented Scale of Improvement)
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.
Measured: After 8 weeks of training with the ALICE app during the final appointment
COSI (Client Oriented Scale of Improvement)
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.
Measured: During the appointment at the end of the hearing aid trial period
CAS (Communication and Acceptance Scale)
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 French (and back translated to ensure correct translation).
Measured: During the first appointment before using the ALICE app
CAS (Communication and Acceptance Scale)
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 French (and back translated to ensure correct translation).
Measured: During the first appointment before the hearing aid trial period
CAS (Communication and Acceptance Scale)
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 French (and back translated to ensure correct translation).
Measured: During an appointment 2 weeks into the hearing aid trial period
CAS (Communication and Acceptance Scale)
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 French (and back translated to ensure correct translation).
Measured: After 8 weeks of training with the ALICE app during the final appointment
CAS (Communication and Acceptance Scale)
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 French (and back translated to ensure correct translation).
Measured: During the appointment at the end of the hearing aid trial period
EAS (Effort Assessment Scale)
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 and French for this study.
Measured: During the first appointment before using the ALICE app
EAS (Effort Assessment Scale)
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 and French for this study.
Measured: After 8 weeks of training with the ALICE app during the final appointment
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. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch and French.
Measured: During the first appointment before using the ALICE app
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. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch and French.
Measured: During the first appointment before the hearing aid trial period
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. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch and French.
Measured: After 8 weeks of training with the ALICE app during the final appointment
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. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch and French.
Measured: During the appointment at the end of the hearing aid trial period
IOI-HA (International Outcome Inventory for Hearing Aids)
The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).
Measured: During the first appointment before using the ALICE app
IOI-HA (International Outcome Inventory for Hearing Aids)
The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).
Measured: During the first appointment before the hearing aid trial period
IOI-HA (International Outcome Inventory for Hearing Aids)
The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).
Measured: After 8 weeks of training with the ALICE app during the final appointment
IOI-HA (International Outcome Inventory for Hearing Aids)
The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).
Measured: During the appointment at the end of the hearing aid trial period
The ALICE-specific Questionnaire
A specific ALICE-questionnaire was developed for the purpose of this study. The questions of this questionnaire were based on 3 different questionnaires. First, the SUS (system usability scale) to determine the usability of the ALICE app. Second, the SADL (Satisfaction with Amplification in Daily Living) which was designed to evaluate the satisfaction that people experience with their hearing aids. Third, the PREM (Patient Reported Experience Measures) as is used to evaluate audiological centres in the Netherlands. A total of 20 questions were selected to evaluate the participants' experience with the usability of the ALICE app, their satisfaction with their hearing aids and their satisfaction with their audiologist/hearing centre. The questionnaire is used in Dutch and French.
Measured: During an appointment 2 weeks into the hearing aid trial period
The ALICE-specific Questionnaire
A specific ALICE-questionnaire was developed for the purpose of this study. The questions of this questionnaire were based on 3 different questionnaires. First, the SUS (system usability scale) to determine the usability of the ALICE app. Second, the SADL (Satisfaction with Amplification in Daily Living) which was designed to evaluate the satisfaction that people experience with their hearing aids. Third, the PREM (Patient Reported Experience Measures) as is used to evaluate audiological centres in the Netherlands. A total of 20 questions were selected to evaluate the participants' experience with the usability of the ALICE app, their satisfaction with their hearing aids and their satisfaction with their audiologist/hearing centre.
The questionnaire is used in Dutch and French.
Measured: During the appointment at the end of the hearing aid trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Oct 2022
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing DisabilityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the training group or the control group.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Astrid van Wieringen, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329922
- Sponsor's protocol ID
- S66285
- Acronym
- ALICE
- Status last verified
- Aug 2025
- First submitted
- 6 Apr 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Wieringen A, Van Wilderode M, De Ridder L, Francart T, Wouters J. ALICE: Improved Speech in Noise Understanding with Self-guided Hearing Care. Trends Hear. 2025 Jan-Dec;29:23312165251393034. doi: 10.1177/23312165251393034. Epub 2025 Nov 10.
PubMed 41212721
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant for LIstening and Communication Enhancement
- ClinicalTrials.gov ID
- NCT05329922
- Acronym / sponsor ID
- ALICE / S66285
- Conditions
- Hearing Disability
- Keywords
- Auditory rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is set-up as a pre-market clinical investigation of a non-CE marked medical device. The main goal of the study is to measure the efficacy of the ALICE app (Assistant for Listening and Communication Enhancement), a newly developed software application that will function as an added service in the aural rehabilitation of persons with HI, by providing remote monitoring, training and follow-up.
We will evaluate the efficacy and the clinical validity of the ALICE-app by means of a randomized controlled trial (RCT) with three arms. The first arm of the RCT will be carried out with 180 experienced hearing aid and/or cochlear implant users. The second arm of the RCT will be carried out with 120 first time hearing aid users. The third arm of the RCT includes an evaluation of the French version of the ALICE app, which will be carried out in 120 experienced hearing aid users from the French-speaking part of Belgium (the Walloon Region and Brussels).The participants will be divided in two groups: one group receiving the standard of care (control group), and another group receiving the standard of care supplemented with the ALICE-app.
All participants in the first and third arm will be assessed two times, at the beginning of the study and after 8 weeks of training (or without for the control group). The participants in the second arm will be assessed three times, at the beginning of the study, during the trial period with hearing aids and at the end of their trial period. The trial period with hearing aids takes on average 4-6 weeks. For the assessment we will use standardized clinical measures. These measures include a speech perception test in noise and validated questionnaires. The efficacy of ALICE will be determined in a within-subject design, i.e., baseline session outcomes will be compared to the final session outcomes of the randomized control trial, with a repeated measures ANOVA (α = 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are randomly assigned to either the training group or the control group.
| Arm | Type | Receives |
|---|---|---|
| ALICE (experienced hearing aid/cochlear implant users) | Experimental | Behavioral: ALICE: Audiological rehabilitationClients 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. |
| Control (experienced hearing aid/cochlear implant users) | No intervention | –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. |
| ALICE (new hearing aid users) | Experimental | Behavioral: ALICE: Audiological rehabilitationClients participating in this arm are asked to train their listening and communication skills using the ALICE app on their personal smart device during the hearing aid trial period (4-6 weeks on average). |
| Control (new hearing aid users) | No intervention | –This arm will receive the standard of care given to the client during the hearing aid trial period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clients who are starting their hearing aid trial as a first time hearing aid user (N= 120). Which is more than necessary according to the power analysis (3.5.7).
- Clients who experience listening and communication difficulties
- 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).
- At least 18 years old.
- Dutch-speaking as all training material and counselling questions will be presented in Dutch
Key exclusion criteria (3 listed)
- Visually impaired
- Motorically impaired
- Cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALICE: Audiological rehabilitationAlso: Use of the ALICE appPersons who are randomised into this arm of the study will be asked to train their listening and communication skills using the ALICE app. | Behavioural | ALICE (experienced hearing aid/cochlear implant users), ALICE (new hearing aid users) |
Primary outcome
Speech in noise intelligibility
Time frame: During the first appointment before using the ALICE app
Dutch: 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. French: Listes disyllabiques de Lafon: disyllabic words presented in speech-weighted noise. Participants are required to repeat words in noise. The "Listes disyllabiques de Lafon" is a validated speech test during which French words are provided in quiet or in noise (Marie-Haps procedure).
Speech in noise intelligibility
Time frame: After 8 weeks of training with the ALICE app during the final appointment
Dutch: 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. French: Listes disyllabiques de Lafon: disyllabic words presented in speech-weighted noise. Participants are required to repeat words in noise. The "Listes disyllabiques de Lafon" is a validated speech test during which French words are provided in quiet or in noise (Marie-Haps procedure).
Speech in noise intelligibility
Time frame: During the first appointment before the hearing aid trial period
BLU (Brugge-Leuven-Utrecht list) words presented in speech-weighted noise. Participants are required to repeat words in noise. The Brugge-Leuven-Utrecht list (BLU, ((Bosman, Woutes \& Damman), 1994)) is a validated speech test during which Dutch words are provided in quiet or in noise. Each list contains 10 2-sylable words.
Speech in noise intelligibility
Time frame: During an appointment 2 weeks into the hearing aid trial period
BLU (Brugge-Leuven-Utrecht list) words presented in speech-weighted noise. Participants are required to repeat words in noise. The Brugge-Leuven-Utrecht list (BLU, ((Bosman, Woutes \& Damman), 1994)) is a validated speech test during which Dutch words are provided in quiet or in noise. Each list contains 10 2-sylable words.
Speech in noise intelligibility
Time frame: During the appointment at the end of the hearing aid trial period
BLU (Brugge-Leuven-Utrecht list) words presented in speech-weighted noise. Participants are required to repeat words in noise. The Brugge-Leuven-Utrecht list (BLU, ((Bosman, Woutes \& Damman), 1994)) is a validated speech test during which Dutch words are provided in quiet or in noise. Each list contains 10 2-sylable words.
21 secondary outcomes
COSI (Client Oriented Scale of Improvement)
Time frame: During the first appointment before using the ALICE app
COSI (Client Oriented Scale of Improvement)
Time frame: During the first appointment before the hearing aid trial period
COSI (Client Oriented Scale of Improvement)
Time frame: After 8 weeks of training with the ALICE app during the final appointment
COSI (Client Oriented Scale of Improvement)
Time frame: During the appointment at the end of the hearing aid trial period
CAS (Communication and Acceptance Scale)
Time frame: During the first appointment before using the ALICE app
CAS (Communication and Acceptance Scale)
Time frame: During the first appointment before the hearing aid trial period
CAS (Communication and Acceptance Scale)
Time frame: During an appointment 2 weeks into the hearing aid trial period
CAS (Communication and Acceptance Scale)
Time frame: After 8 weeks of training with the ALICE app during the final appointment
CAS (Communication and Acceptance Scale)
Time frame: During the appointment at the end of the hearing aid trial period
EAS (Effort Assessment Scale)
Time frame: During the first appointment before using the ALICE app
EAS (Effort Assessment Scale)
Time frame: After 8 weeks of training with the ALICE app during the final appointment
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: During the first appointment before using the ALICE app
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: During the first appointment before the hearing aid trial period
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: After 8 weeks of training with the ALICE app during the final appointment
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: During the appointment at the end of the hearing aid trial period
IOI-HA (International Outcome Inventory for Hearing Aids)
Time frame: During the first appointment before using the ALICE app
IOI-HA (International Outcome Inventory for Hearing Aids)
Time frame: During the first appointment before the hearing aid trial period
IOI-HA (International Outcome Inventory for Hearing Aids)
Time frame: After 8 weeks of training with the ALICE app during the final appointment
IOI-HA (International Outcome Inventory for Hearing Aids)
Time frame: During the appointment at the end of the hearing aid trial period
The ALICE-specific Questionnaire
Time frame: During an appointment 2 weeks into the hearing aid trial period
The ALICE-specific Questionnaire
Time frame: During the appointment at the end of the hearing aid trial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 41212721van Wieringen A, Van Wilderode M, De Ridder L, Francart T, Wouters J. ALICE: Improved Speech in Noise Understanding with Self-guided Hearing Care. Trends Hear. 2025 Jan-Dec;29:23312165251393034. doi: 10.1177/23312165251393034. Epub 2025 Nov 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid van Wieringen, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALICE: Audiological rehabilitation in people with Hearing Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech in noise intelligibility (time frame: During the first appointment before using the ALICE app). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.