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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-10

Study Completion Date

2022-09-30

Brief Summary

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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

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Detailed Description

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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

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Dysphagia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No