Status:
UNKNOWN
Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home CHEZ LES PERSONNES AGEES EN EHPAD
Lead Sponsor:
Swallis Medical
Conditions:
Dysphagia
Eligibility:
All Genders
60+ years
Brief Summary
SWALL EHPAD is a multicenter, prospective study on the use and Acceptability Study of Swallis DSA™ Medical Device for Distanced Swallowing Assessment for Older Adults In Nursing Home
Detailed Description
Swallowing disorders are frequent in nursing homes and under-assessed, under-diagnosed, and under-managed. The SWALLIS DSA™ investigative device is intended to capture and display pharyngolaryngeal ac...
Eligibility Criteria
Inclusion
- Subject over 60 years old residing in nursing homes
- Subject with a medical prescription for a swallowing assessment
- Subject affiliated or benefiting from the social security system
- Consent to participate obtained in writing and signed by the subject if he/she is able to give his/her consent, or if necessary by the family or, in case of guardianship, by the legally designated representative
Exclusion
- Presence of skin lesion(s) on the neck
- Any serious pathology (severe medical condition or behavioral disorder) where, in the opinion of the investigator, it may place participants at additional risk
- Tracheostomized subject
- Subjects with a nasogastric feeding tube
- Subjects under court protection
Key Trial Info
Start Date :
May 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05366374
Start Date
May 10 2022
End Date
September 1 2022
Last Update
June 8 2022
Active Locations (3)
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1
Ehpad St Jacques
Grenade, France, 31330
2
Ehpad La Résidence
Lisle-sur-Tarn, France, 81310
3
EHPAD L Espérance
Pointis-de-Rivière, France, 31210