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

NCT05366374 | Unknown

• 1 other identifier: 2021-A02894-37
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants who carry the device over the full length of the meal

  1 day

• factors that limit the wearing of the device

  1 day

• Quality of the video recording

  up to 6 months

Interventions

Swallowing assessment with Swallis DSA™ Device OTHER

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

older people living in nursing home diagnosed or suspected of dysphagia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swallis Medical: lead

Study Sites (3)

Ehpad St Jacques

Grenade, 31330, France

NOT YET RECRUITING

Ehpad La Résidence

Lisle-sur-Tarn, 81310, France

NOT YET RECRUITING

EHPAD L Espérance

Pointis-de-Rivière, 31210, France

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Gaelle SORIANO

CONTACT

33(0)7.61.43.17.41; g.soriano@swallismedical.com

Fabrice Neveu

CONTACT

33(0)7.61.43.17.41; f.neveu@swallismedical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 9, 2022
• Study Start: May 10, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)