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

Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Swallis Medical · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
OTHER	Swallowing 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.

Timeline

• Start date: 2022-05-10
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-05-09
• Last updated: 2022-06-08

Locations

3 sites across 1 country: France