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

June 7, 2022 updated by: Swallis Medical

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

older people living in nursing home diagnosed or suspected of dysphagia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reproducibility between the swallowing assessment performed in presence and at a distance
Time Frame: 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
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who carry the device over the full length of the meal
Time Frame: 1 day
measurement of the time during which the device is worn
1 day
factors that limit the wearing of the device
Time Frame: 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
1 day
Quality of the video recording
Time Frame: up to 6 months
satisfaction scale for the speech therapist
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swallis Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02894-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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