Clinical trial NCT05366374: Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home CHEZ LES PERSONNES AGEES EN EHPAD
Official title: Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysphagia
Lead sponsor: Swallis Medical
Sponsor class: INDUSTRY
First posted: 2022-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: older people living in nursing home diagnosed or suspected of dysphagia

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 activity in subjects with or at risk for swallowing disorders. This device will thus open the way to telecare in the field of swallowing, the expected benefit of which is to improve access to care in the population of subjects living in Nursing Home

This study aims to verify three hypotheses:

1. The recording of the clinical swallowing assessment performed by the speech therapist at a distance allows observation and an interpretation equivalent to the clinical assessment performed in the presence.
2. This device is accepted by all the beneficiaries (residents) and users (nursing staff) in the usual context of a meal situation in a Nursing Home.
3. This device allows the identification of the events marked by the speech therapist and the analysis of the corresponding vibro-acoustic signals.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: reproducibility between the swallowing assessment performed in presence and at a distance
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of participants who carry the device over the full length of the meal
timeFrame: 1 day
measure: factors that limit the wearing of the device
timeFrame: 1 day
measure: Quality of the video recording
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Grenade
country: France
facility: Ehpad St Jacques
city: Lisle Sur Tarn
country: France
facility: Ehpad La Résidence
city: Pointis-de-Rivière
country: France
facility: EHPAD L Espérance
Study officials:
References: