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

Last updated: June 7, 2022
Sponsor: Swallis Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn

Treatment

N/A

Clinical Study ID

NCT05366374
2021-A02894-37
  • Ages > 60
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 ableto give his/her consent, or if necessary by the family or, in case of guardianship, bythe legally designated representative

Exclusion

Exclusion Criteria:

  • Presence of skin lesion(s) on the neck
  • Any serious pathology (severe medical condition or behavioral disorder) where, in theopinion of the investigator, it may place participants at additional risk
  • Tracheostomized subject
  • Subjects with a nasogastric feeding tube
  • Subjects under court protection

Study Design

Total Participants: 100
Study Start date:
May 10, 2022
Estimated Completion Date:
September 30, 2022

Study 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.

Connect with a study center

  • Ehpad St Jacques

    Grenade, 31330
    France

    Site Not Available

  • Ehpad La Résidence

    Lisle Sur Tarn, 81310
    France

    Site Not Available

  • EHPAD L Espérance

    Pointis-de-Rivière, 31210
    France

    Active - Recruiting

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