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

Dysphagia Clinical Trial

— SWALL EHPAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366374
• Other study ID #: 2021-A02894-37
• Status: Recruiting
• Start date: May 10, 2022
• Est. completion date: September 2022

Study information

• Verified date: June 2022
• Source: Swallis Medical
• Contact: Gaelle SORIANO
• Phone: 33(0)7.61.43.17.41
• Email: g.soriano[@]swallismedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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.

Locations

Country	Name	City	State
France	Ehpad St Jacques	Grenade
France	Ehpad La Résidence	Lisle Sur Tarn
France	EHPAD L Espérance	Pointis-de-Rivière

Sponsors (1)

Lead Sponsor	Collaborator
Swallis Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reproducibility between the swallowing assessment performed in presence and at a distance	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	up to 6 months
Secondary	Number of participants who carry the device over the full length of the meal	measurement of the time during which the device is worn	1 day
Secondary	factors that limit the wearing of the device	subject's characteristics according to medical history (pathologies, cognitive state, installation and posture); subjective assessment of difficulty or inability of caregivers to perform the data collection procedure	1 day
Secondary	Quality of the video recording	satisfaction scale for the speech therapist	up to 6 months

External Links

•   Swallis Medical Website