Dysphagia
Conditions
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.
Interventions
OTHERSwallowing assessment with Swallis DSA™ Device
The WALLIS DSA™ investigative device is designed to capture and display pharyngolaryngeal activity in subjects with or at risk of swallowing disorders. The DM is non-invasive: a miniaturized microphone and accelerometer are integrated into the form of a necklace, which will be positioned around the patient's neck to capture the vibroacoustic signals of swallowing during mealtime.
Sponsors
Swallis Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reproducibility between the swallowing assessment performed in presence and at a distance | up to 6 months | Comparison of the recommendations resulting from the 2 swallowing assessments carried out by the speech therapist in presence and the speech therapist at a distance on the food adaptations, the assistance with the meals, the need for a check-up or dental care, the adaptation of the environment and the posture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who carry the device over the full length of the meal | 1 day | measurement of the time during which the device is worn |
| factors that limit the wearing of the device | 1 day | 1. subject's characteristics according to medical history (pathologies, cognitive state, installation and posture) 2. subjective assessment of difficulty or inability of caregivers to perform the data collection procedure |
| Quality of the video recording | up to 6 months | satisfaction scale for the speech therapist |
Countries
France
Contacts
Primary ContactGaelle SORIANO
Backup ContactFabrice Neveu
Outcome results
None listed