Assistant for LIstening and Communication Enhancement (NCT05329922) | Clinical Trial Compass
CompletedNot Applicable
Assistant for LIstening and Communication Enhancement
Belgium161 participantsStarted 2022-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Experienced hearing aid/cochlear implant users):
* Clients with a hearing aid or cochlear implant.
* Clients with a hearing aid must have completed the hearing aid trial period and must have decided to purchase the hearing aid.
* Clients with a cochlear implant must have at least 6 months of experience with the implant.
* Clients who experience listening and communication difficulties.
* Clients may not have any experience with auditory training yet.
* 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.
* Arm 1: Dutch-speaking as all training material and counselling questions will be presented in Dutch.
* Arm 3: French-speaking as all training material and counselling questions will be presented in French.
* Clients need to have an Android or iPhone smart device and connection to internet
Inclusion Criteria (New hearing aid users):
* 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 operat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Speech in noise intelligibility
Timeframe: During the first appointment before using the ALICE app
2
Speech in noise intelligibility
Timeframe: After 8 weeks of training with the ALICE app during the final appointment
3
Speech in noise intelligibility
Timeframe: During the first appointment before the hearing aid trial period
4
Speech in noise intelligibility
Timeframe: During an appointment 2 weeks into the hearing aid trial period
5
Speech in noise intelligibility
Timeframe: During the appointment at the end of the hearing aid trial period