Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home CHEZ LES PERSONNES AGEES EN EHPAD

• Conditions: Dysphagia

• Registration Number: NCT05366374
• Lead Sponsor: Swallis Medical

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.

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-05-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-08
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Ehpad La Résidence; 🇫🇷 Lisle Sur Tarn, France

Ehpad St Jacques; 🇫🇷 Grenade, France

EHPAD L Espérance; 🇫🇷 Pointis-de-Rivière, France