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Identifiant

S66285

Titre

Assistant for listening and communication enhancement
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05329922

Auditory rehabilitation

Source : Importé depuis le centre

Recrutement possiblement ouvert

Dernière modification : 2024/08/18

Centres participants

Ku leuven, experimental orl, dept neurosciences

Type de recherche

Interventionnel

Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'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

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes

Nom	Condition médicale	Traitement	État du recrutement
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.	Donnée non disponible	Inconnu
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.	Donnée non disponible	Inconnu
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).	Donnée non disponible	Inconnu
Control (new hearing aid users)	This arm will receive the standard of care given to the client during the hearing aid trial period.	Donnée non disponible	Inconnu

ALICE (experienced hearing aid/cochlear implant users)

État du recrutement

unknown

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.

Control (experienced hearing aid/cochlear implant users)

État du recrutement

unknown

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)

État du recrutement

unknown

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).

Control (new hearing aid users)

État du recrutement

unknown

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

Données à jour depuis : 18 août 2024

Description de l'étude

Résumé de l'étude

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.

Source : Importé depuis le centre

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).

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KU LEUVEN, EXPERIMENTAL ORL, DEPT NEUROSCIENCES

Leuven

VLAAMS BRABANT, BELGIUM

Recrutement local

État du recrutement: INCONNU

Dernière modification : 18 août 2024
Données à jour depuis : 20 août
Origine des données : clinicaltrials.gov

Référence clinicaltrials.gov: NCT05329922

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S66285

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Assistant for listening and communication enhancement
Source : Importé depuis le centre

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Identifiant S66285

Titre Assistant for listening and communication enhancement Source : Importé depuis le centre

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Identifiant

S66285

Titre

Assistant for listening and communication enhancement
Source : Importé depuis le centre