Assistant for LIstening and Communication Enhancement

Hearing Disability Clinical Trial

— ALICE  

Official title:

Assistant for LIstening and Communication Enhancement

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05329922
• Other study ID #: S66285
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 two 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 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 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: August 31, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• Dutch-speaking as all training material and counselling questions will be presented in Dutch.
• 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

Related Conditions & MeSH terms

• Hearing Disability

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Belgium	KU Leuven, Experimental ORL, Dept Neurosciences	Leuven	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech in noise intelligibility	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.	During the first appointment before using the ALICE app
Primary	Speech in noise intelligibility	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.	After 8 weeks of training with the ALICE app during the final appointment
Primary	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
Primary	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
Primary	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	COSI (Client Oriented Scale of Improvement)	The COSI questionnaire is a validated clinical tool that can assist in measuring the impact of hearing aid fitting on a person's life and the benefit that is obtained after intervention (Dillon et al., 1997). Administering the COSI questionnaire is also part of the RIZIV application to receive a refund for hearing aids. The COSI questionnaire allows the audiologist to measure improvements in listening situations important for their client. Before fitting the hearing aids, together with their client, they list their client's needs/goals. After hearing aids have been fitted and the client has had time to experience the hearing aids, they evaluate the progression/satisfaction in these situations together with their client.	During the first appointment before using the ALICE app
Secondary	COSI (Client Oriented Scale of Improvement)	The COSI questionnaire is a validated clinical tool that can assist in measuring the impact of hearing aid fitting on a person's life and the benefit that is obtained after intervention (Dillon et al., 1997). Administering the COSI questionnaire is also part of the RIZIV application to receive a refund for hearing aids. The COSI questionnaire allows the audiologist to measure improvements in listening situations important for their client. Before fitting the hearing aids, together with their client, they list their client's needs/goals. After hearing aids have been fitted and the client has had time to experience the hearing aids, they evaluate the progression/satisfaction in these situations together with their client.	During the first appointment before the hearing aid trial period
Secondary	COSI (Client Oriented Scale of Improvement)	The COSI questionnaire is a validated clinical tool that can assist in measuring the impact of hearing aid fitting on a person's life and the benefit that is obtained after intervention (Dillon et al., 1997). Administering the COSI questionnaire is also part of the RIZIV application to receive a refund for hearing aids. The COSI questionnaire allows the audiologist to measure improvements in listening situations important for their client. Before fitting the hearing aids, together with their client, they list their client's needs/goals. After hearing aids have been fitted and the client has had time to experience the hearing aids, they evaluate the progression/satisfaction in these situations together with their client.	After 8 weeks of training with the ALICE app during the final appointment
Secondary	COSI (Client Oriented Scale of Improvement)	The COSI questionnaire is a validated clinical tool that can assist in measuring the impact of hearing aid fitting on a person's life and the benefit that is obtained after intervention (Dillon et al., 1997). Administering the COSI questionnaire is also part of the RIZIV application to receive a refund for hearing aids. The COSI questionnaire allows the audiologist to measure improvements in listening situations important for their client. Before fitting the hearing aids, together with their client, they list their client's needs/goals. After hearing aids have been fitted and the client has had time to experience the hearing aids, they evaluate the progression/satisfaction in these situations together with their client.	During the appointment at the end of the hearing aid trial period
Secondary	CAS (Communication and Acceptance Scale)	The CAS is a validated scale that consist of 18 items (Öberg et al., 2021). The CAS scale is a reliable instrument that can be used to measure the effect of a rehabilitation programme. Each question is scored on a 5-point Likert scale (completely agree to completely disagree). It was developed to detect clinical changes in "communication strategies and the emotional consequences, knowledge and acceptance of hearing loss". This questionnaire has been translated from Swedish to Dutch (and back translated to ensure correct translation).	During the first appointment before using the ALICE app
Secondary	CAS (Communication and Acceptance Scale)	The CAS is a validated scale that consist of 18 items (Öberg et al., 2021). The CAS scale is a reliable instrument that can be used to measure the effect of a rehabilitation programme. Each question is scored on a 5-point Likert scale (completely agree to completely disagree). It was developed to detect clinical changes in "communication strategies and the emotional consequences, knowledge and acceptance of hearing loss". This questionnaire has been translated from Swedish to Dutch (and back translated to ensure correct translation).	During the first appointment before the hearing aid trial period
Secondary	CAS (Communication and Acceptance Scale)	The CAS is a validated scale that consist of 18 items (Öberg et al., 2021). The CAS scale is a reliable instrument that can be used to measure the effect of a rehabilitation programme. Each question is scored on a 5-point Likert scale (completely agree to completely disagree). It was developed to detect clinical changes in "communication strategies and the emotional consequences, knowledge and acceptance of hearing loss". This questionnaire has been translated from Swedish to Dutch (and back translated to ensure correct translation).	During an appointment 2 weeks into the hearing aid trial period
Secondary	CAS (Communication and Acceptance Scale)	The CAS is a validated scale that consist of 18 items (Öberg et al., 2021). The CAS scale is a reliable instrument that can be used to measure the effect of a rehabilitation programme. Each question is scored on a 5-point Likert scale (completely agree to completely disagree). It was developed to detect clinical changes in "communication strategies and the emotional consequences, knowledge and acceptance of hearing loss". This questionnaire has been translated from Swedish to Dutch (and back translated to ensure correct translation).	After 8 weeks of training with the ALICE app during the final appointment
Secondary	CAS (Communication and Acceptance Scale)	The CAS is a validated scale that consist of 18 items (Öberg et al., 2021). The CAS scale is a reliable instrument that can be used to measure the effect of a rehabilitation programme. Each question is scored on a 5-point Likert scale (completely agree to completely disagree). It was developed to detect clinical changes in "communication strategies and the emotional consequences, knowledge and acceptance of hearing loss". This questionnaire has been translated from Swedish to Dutch (and back translated to ensure correct translation).	During the appointment at the end of the hearing aid trial period
Secondary	EAS (Effort Assessment Scale)	EAS is a validated scale to measure listening effort (Alhanbali et al., 2017). The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.	During the first appointment before using the ALICE app
Secondary	EAS (Effort Assessment Scale)	EAS is a validated scale to measure listening effort (Alhanbali et al., 2017). The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.	After 8 weeks of training with the ALICE app during the final appointment
Secondary	SSQ12 (Speech, Spatial and Qualities of Hearing Scale)	The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.	During the first appointment before using the ALICE app
Secondary	SSQ12 (Speech, Spatial and Qualities of Hearing Scale)	The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.	During the first appointment before the hearing aid trial period
Secondary	SSQ12 (Speech, Spatial and Qualities of Hearing Scale)	The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.	After 8 weeks of training with the ALICE app during the final appointment
Secondary	SSQ12 (Speech, Spatial and Qualities of Hearing Scale)	The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. (Noble et al., 2013). Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.	During the appointment at the end of the hearing aid trial period
Secondary	IOI-HA (International Outcome Inventory for Hearing Aids)	The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).	During the first appointment before using the ALICE app
Secondary	IOI-HA (International Outcome Inventory for Hearing Aids)	The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).	During the first appointment before the hearing aid trial period
Secondary	IOI-HA (International Outcome Inventory for Hearing Aids)	The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).	After 8 weeks of training with the ALICE app during the final appointment
Secondary	IOI-HA (International Outcome Inventory for Hearing Aids)	The IOI-HA (International Outcome Inventory for Hearing Aids) evaluates the daily use of the hearing aid, as well as the perceived benefit and satisfaction with the hearing aids or cochlear implants. The IOI-HA consist of 7 questions and has been validated in Dutch (Kramer et al., 2002).	During the appointment at the end of the hearing aid trial period
Secondary	The ALICE-specific Questionnaire	A specific ALICE-questionnaire was developed for the purpose of this study. The questions of this questionnaire were based on 3 different questionnaires. First, the SUS (system usability scale) to determine the usability of the ALICE app. Second, the SADL (Satisfaction with Amplification in Daily Living) which was designed to evaluate the satisfaction that people experience with their hearing aids. Third, the PREM (Patient Reported Experience Measures) as is used to evaluate audiological centres in the Netherlands. A total of 20 questions were selected to evaluate the participants' experience with the usability of the ALICE app, their satisfaction with their hearing aids and their satisfaction with their audiologist/hearing centre.	During an appointment 2 weeks into the hearing aid trial period
Secondary	The ALICE-specific Questionnaire	A specific ALICE-questionnaire was developed for the purpose of this study. The questions of this questionnaire were based on 3 different questionnaires. First, the SUS (system usability scale) to determine the usability of the ALICE app. Second, the SADL (Satisfaction with Amplification in Daily Living) which was designed to evaluate the satisfaction that people experience with their hearing aids. Third, the PREM (Patient Reported Experience Measures) as is used to evaluate audiological centres in the Netherlands. A total of 20 questions were selected to evaluate the participants' experience with the usability of the ALICE app, their satisfaction with their hearing aids and their satisfaction with their audiologist/hearing centre.	During the appointment at the end of the hearing aid trial period