Clinical trial NCT05329922: Assistant for LIstening and Communication Enhancement
Official title: Assistant for LIstening and Communication Enhancement
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hearing Disability
Keywords: Auditory rehabilitation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2022-04-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the training group or the control group.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Speech in noise intelligibility
timeFrame: During the first appointment before using the ALICE app
measure: Speech in noise intelligibility
timeFrame: After 8 weeks of training with the ALICE app during the final appointment
measure: Speech in noise intelligibility
timeFrame: During the first appointment before the hearing aid trial period
measure: Speech in noise intelligibility
timeFrame: During an appointment 2 weeks into the hearing aid trial period
measure: Speech in noise intelligibility
timeFrame: During the appointment at the end of the hearing aid trial period
Secondary outcomes:
measure: COSI (Client Oriented Scale of Improvement)
timeFrame: During the first appointment before using the ALICE app
measure: COSI (Client Oriented Scale of Improvement)
timeFrame: During the first appointment before the hearing aid trial period
measure: COSI (Client Oriented Scale of Improvement)
timeFrame: After 8 weeks of training with the ALICE app during the final appointment
measure: COSI (Client Oriented Scale of Improvement)
timeFrame: During the appointment at the end of the hearing aid trial period
measure: CAS (Communication and Acceptance Scale)
timeFrame: During the first appointment before using the ALICE app
measure: CAS (Communication and Acceptance Scale)
timeFrame: During the first appointment before the hearing aid trial period
measure: CAS (Communication and Acceptance Scale)
timeFrame: During an appointment 2 weeks into the hearing aid trial period
measure: CAS (Communication and Acceptance Scale)
timeFrame: After 8 weeks of training with the ALICE app during the final appointment
measure: CAS (Communication and Acceptance Scale)
timeFrame: During the appointment at the end of the hearing aid trial period
measure: EAS (Effort Assessment Scale)
timeFrame: During the first appointment before using the ALICE app
measure: EAS (Effort Assessment Scale)
timeFrame: After 8 weeks of training with the ALICE app during the final appointment
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: During the first appointment before using the ALICE app
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: During the first appointment before the hearing aid trial period
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: After 8 weeks of training with the ALICE app during the final appointment
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: During the appointment at the end of the hearing aid trial period
measure: IOI-HA (International Outcome Inventory for Hearing Aids)
timeFrame: During the first appointment before using the ALICE app
measure: IOI-HA (International Outcome Inventory for Hearing Aids)
timeFrame: During the first appointment before the hearing aid trial period
measure: IOI-HA (International Outcome Inventory for Hearing Aids)
timeFrame: After 8 weeks of training with the ALICE app during the final appointment
measure: IOI-HA (International Outcome Inventory for Hearing Aids)
timeFrame: During the appointment at the end of the hearing aid trial period
measure: The ALICE-specific Questionnaire
timeFrame: During an appointment 2 weeks into the hearing aid trial period
measure: The ALICE-specific Questionnaire
timeFrame: During the appointment at the end of the hearing aid trial period
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven, Experimental ORL, Dept Neurosciences
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Astrid van Wieringen, PhD
role: PRINCIPAL_INVESTIGATOR
References: