Assistant for LIstening and Communication Enhancement

NCT05329922 | Completed

• 1 other identifier: S66285
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Disability

Keywords

Auditory rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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.

  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.

  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.

  During the appointment at the end of the hearing aid trial period

Secondary Outcomes (21)

• COSI (Client Oriented Scale of Improvement)

  During the first appointment before using the ALICE app

• COSI (Client Oriented Scale of Improvement)

  During the first appointment before the hearing aid trial period

• COSI (Client Oriented Scale of Improvement)

  After 8 weeks of training with the ALICE app during the final appointment

• COSI (Client Oriented Scale of Improvement)

  During the appointment at the end of the hearing aid trial period

• CAS (Communication and Acceptance Scale)

  During the first appointment before using the ALICE app

Study Arms (4)

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.

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).

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.

Interventions

ALICE: Audiological rehabilitation 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.

Also known as: Use of the ALICE app

ALICE (experienced hearing aid/cochlear implant users); ALICE (new hearing aid users)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Visually impaired
• Motorically impaired
• Cognitively impaired

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

KU Leuven, Experimental ORL, Dept Neurosciences

Leuven, VLAAMS BRABANT, 3001, Belgium

Location

Related Publications (1)

• 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.

  PMID: 41212721 RESULT

Study Officials

• Astrid van Wieringen, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the training group or the control group.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 15, 2022
• Study Start: October 1, 2022
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)