Assistant for LIstening and Communication Enhancement

NCT ID: NCT05329922

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-08-14

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALICE (experienced hearing aid/cochlear implant users)

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.

Group Type: EXPERIMENTAL

ALICE: Audiological rehabilitation

Intervention Type: BEHAVIORAL

Persons who are randomised into this arm of the study will be asked to train their listening and communication skills using the ALICE app.

Control (experienced hearing aid/cochlear implant users)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ALICE (new hearing aid users)

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).

Group Type: EXPERIMENTAL

ALICE: Audiological rehabilitation

Intervention Type: BEHAVIORAL

Persons who are randomised into this arm of the study will be asked to train their listening and communication skills using the ALICE app.

Control (new hearing aid users)

This arm will receive the standard of care given to the client during the hearing aid trial period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Use of the ALICE app

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Visually impaired
• Motorically impaired
• Cognitively impaired

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid van Wieringen, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven, Experimental ORL, Dept Neurosciences

Leuven, VLAAMS BRABANT, Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 41212721 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

S66285

Identifier Type: -

Identifier Source: org_study_id