Status:
COMPLETED
Assistant for LIstening and Communication Enhancement
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
KU Leuven
Conditions:
Hearing Disability
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 Commu...
Eligibility Criteria
Inclusion
- 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 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
- Exclusion Criteria (Both groups):
- Visually impaired
- Motorically impaired
- Cognitively impaired
Exclusion
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2025
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT05329922
Start Date
October 1 2022
End Date
August 14 2025
Last Update
November 28 2025
Active Locations (1)
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1
KU Leuven, Experimental ORL, Dept Neurosciences
Leuven, VLAAMS BRABANT, Belgium, 3001