DysphagiaSWALL EHPADNCT05366374
Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home CHEZ LES PERSONNES AGEES EN EHPAD
An observational study of Dysphagia, run by Swallis Medical at 3 sites in France.
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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Swallowing assessment with Swallis DSA™ Device
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 10 May 2022to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: older people living in nursing home diagnosed or suspected of dysphagia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Ehpad St Jacques
Grenade, 31330
Yann TANNOU, tannou.yann@gmail.com
- Not yet recruiting
Ehpad La Résidence
Lisle-sur-Tarn, 81310
Xavier CORMARY, xavier.cormary@gmail.com
Gaelle Soriano, g.soriano@swallismedical.com
- Recruiting
EHPAD L Espérance
Pointis-de-Rivière, 31210
Muriel Gabas, muriel.gabas@gmail.com
Gaelle Soriano, g.soriano@swallismedical.com
About this study
Official title: 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
Read the 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:
- 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.
- 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.
- This device allows the identification of the events marked by the speech therapist and the analysis of the corresponding vibro-acoustic signals.
- Conditions
- Dysphagia
- Being tested
- Swallowing assessment with Swallis DSA™ Device
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing assessment with Swallis DSA™ DeviceOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Secondary outcomes (3)
Number of participants who carry the device over the full length of the meal
measurement of the time during which the device is worn
Measured: 1 day
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
Measured: 1 day
Quality of the video recording
satisfaction scale for the speech therapist
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start10 May 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swallis Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366374
- Sponsor's protocol ID
- 2021-A02894-37
- Acronym
- SWALL EHPAD
- Status last verified
- Jun 2022
- First submitted
- 11 Apr 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home
- ClinicalTrials.gov ID
- NCT05366374
- Acronym / sponsor ID
- SWALL EHPAD / 2021-A02894-37
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Swallis MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- 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.
- This device allows the identification of the events marked by the speech therapist and the analysis of the corresponding vibro-acoustic signals.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- older people living in nursing home diagnosed or suspected of dysphagia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swallowing assessment with Swallis DSA™ DeviceThe 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. | Other | – |
Primary outcome
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
3 secondary outcomes
Number of participants who carry the device over the full length of the meal
Time frame: 1 day
factors that limit the wearing of the device
Time frame: 1 day
Quality of the video recording
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by Swallis Medical at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaelle SORIANO (33(0)7.61.43.17.41, g.soriano@swallismedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reproducibility between the swallowing assessment performed in presence and at a distance (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.