- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03316287
Big Data Supporting Public Health Hearing Policies (EVOTION)
EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION
Hearing Loss (HL) affects over 5% of the world's population (WHO 2014) and is the 5th leading cause of Years Lived with Disability. HL is currently managed with Hearing Aids (HAs), i.e. programmable sound amplification devices that are worn by the hearing impaired subjects to address their hearing difficulties. HA use however is often problematic, costly and with poor overall benefits. The holistic management of HL requires appropriate public health policies for HL prevention, early diagnosis, long-term treatment and rehabilitation; detection and prevention of cognitive decline; and socioeconomic inclusion of HL patients. Currently the evidential basis for forming such policies is limited.
The EVOTION project proposes to address this by collecting and analysing a big set of heterogeneous data, including HA usage, audiological, physiological, cognitive, clinical and medication, personal, behavioural, life style, occupational and environmental data.
This will be done by:
i. accessing big datasets of existing HA user data from the EVOTION clinical partners (UCL/UCLH and GST in the UK; OTICON in Denmark) ii. collection of prospective HA user data who will be recruited to the prospective EVOTION study and who will undergo some additional assessments iii. collection of real time dynamic data of the human participant HA users who will be given a smart phone with different apps (auditory tests; auditory training), sensors (recording of heart rate, blood pressure, respiratory rate etc.) and smart HAs (recording environmental factors such as noise levels, type of noise etc.) so that real life contextual factors that affect HA usage and outcome can be identified.
These data will be analysed with big data analysis/data mining techniques in order to identify relationships between these in order to use this information to derive and support public health decisions.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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London, Royaume-Uni
- Guy's and St. Thomas' Foundation Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age >18 years
- Basic understanding of oral and written English
- Unilateral and/or bilateral mild to severe sensorineural hearing loss
- Willing to use smart hearing aids for at least 2 hours daily on average
- Willing/capable to use a mobile phone
Exclusion Criteria:
- Dementia (MoCA<22 )
- Not agreeing or able to attend for f/u appointments
- Not agreeing or able to use HA >2 hours daily (average)
- Not sufficient vision to use smartphone ap
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Hearing aid + mobile phone
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Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
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Expérimental: Hearing aid + mobile phone + biosensor
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Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
Wearable biosensor for the collection of physiological data
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks
Délai: Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid
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Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 17/0064
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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