Swallowing DisorderDéGluT'GNCT06163118
Validation of a Screening Tool for Swallowing Disorders for the Elderly
A study testing Deglut'G test, SLP swallowing test and ENT doctor swallowing test in people with Swallowing Disorder and Dysphagia, run by University Hospital Center of Martinique at 1 site in France.
Trial summary
Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Swallowing Disorder, Dysphagia
- What is being tested?
- Deglut'G test, SLP swallowing test and ENT doctor swallowing test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2023to 20 Dec 2024
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Person aged 75 or over hospitalized in the Geriatric Short-Stay Unit,
- Person having been informed of the research,
- Person having given free written and informed consent,
- Person affiliated to a social security scheme.
Who cannot join
- Person unable to take the tests,
- Person with an oral condition that hinders normal swallowing (stomatitis, gingivitis, etc.),
- Elderly person under legal protection, under guardianship or curatorship,
- Person who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Center of Martinique
Fort-de-France, 97261
Yann Mopsus, MSc, yann.mopsus@chu-martinique.fr
Seendy Bartholet, PhD
About this study
Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the mouth and the stomach, sometimes with falsities. These disorders can be the cause of a loss of appetite and a reduction in food consumption in older people.
In the most serious cases, they can lead to aspiration, weakening the pulmonary passages and possibly leading to suffocation.
Read more
Swallowing disorders constitute an important public health problem due to their prevalence among the elderly. Many early readmissions could be avoided thanks to better quality of care in these patients.
In the elderly, the number of comorbidities and the multiplicity of medications and drug intake increase the incidence of swallowing disorders in this population. They constitute a common pathology, probably underestimated and underdiagnosed in the geriatric population.
Given the aging of the Martinique population, it is appropriate to offer an easy-to-use, quickly achievable tool for diagnostic purposes, making it possible to quickly identify potential swallowing disorders, and therefore to anticipate meal intake, and on the adaptation of the prescription to a medicinal alternative (before any food or medication taken during hospitalization).
In the Geriatric Short-Stay Unit of the Martinique University Hospital, a tool called "Deglut'G", was developed, and has been used since 2015, in order to allow caregivers a rapid, reliable and relevant assessment of swallowing disorders in the elderly, in order to guide care and medication alternatives.It now appears important to validate this tool, by comparing it with the results of examinations of swallowing disorders obtained from a speech-language pathologists (SLPs) and an ENT doctor.
- Conditions
- Swallowing Disorder, Dysphagia
- Being tested
- Deglut'G test, SLP swallowing test, ENT doctor swallowing test
- Keywords
- Swallowing Disorder, Dysphagia, Swallowing Disorder test, Bronchopneumonia, Geriatric short-stay unit
- Medical subject headings
- Deglutition Disorders, Bronchopneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deglut'G testDiagnostic test
Two tests to assess swallowing disorders using the Deglut'G tool will be carried out by a nurse or a caregiver from the Geriatric Short-Stay Unit, at visit 1.
The tests can be taken successively, or spaced apart by a time defined by the medical team, and will be taken blind to each other.
The average test administration time will be measured during the study, but the test should not exceed 10 minutes depending on the patients.
The Deglut'G tool consists of an initial administration of gelled water (1 to 3 teaspoons), to identify if a cough occurs. In the event of a cough, the oral treatment is stopped; if the cough is absent, a new step this time consists of the administration of water (1 to 3 sips). In case of cough, the food will be mixed, the liquids thickened, and the medicinal treatments crushed. If there is no cough, foods and liquids can be taken as normal.
SLP swallowing testDiagnostic test
At visit 1, 1 to 2 hours after the last Deglut'G test, a second swallowing test will be carried out by a SLP according to his skills and according to his usual practice, independently of the Deglut'G tool.
This test should not exceed 20-30 minutes depending on the patient.
ENT doctor swallowing testDiagnostic test
At Visit 2 (day 7 +/- 3 days after the inclusion), still as part of the short-stay hospitalization, the patient will meet an ENT doctor who will carry out an examination aimed at detecting swallowing disorders, according to his usual practice, of independent of the Deglut'G tool.
The examination should not exceed 20-30 minutes depending on the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patient aged 75 or over hospitalized in the Geriatric Short-Stay Unit | Experimental | Two caregivers from the Geriatric Short-Stay Unit will successively administer the "Deglut'G" tool to each patient, blind to each other, and blind to the SLP and ENT doctor examination. All patients will have a SLP examination and an ENT doctor examination aimed at detecting swallowing disorders. Receives: Diagnostic Test: Deglut'G test; Diagnostic Test: SLP swallowing test; Diagnostic Test: ENT doctor swallowing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the concordance between the results of the SLP examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders.
Concordance between the results of the Deglut'G test and the SLP assessment.
The evaluation of a swallowing disorder via the DegluT'G tool, by the geriatric short-stay unit caregivers, will be done as follows:
- Presence of cough following administration of gelled water : suspicion of swallowing disorder
- Presence of cough following administration of water : suspicion of swallowing disorder
- Absence of cough following administration of water : no swallowing disorder
This assessment will be compared to the SLP assessment, whatever the assessment method used.
Measured: 12 months
Secondary outcomes (3)
Measure the concordance between the results of the ENT doctor examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders
Concordance between the results of the Deglut'G test and the ENT doctor assessment.
The evaluation of a swallowing disorder via the DegluT'G tool, by the geriatric short-stay unit caregivers, will be done as follows:
- Presence of cough following administration of gelled water : suspicion of swallowing disorder
- Presence of cough following administration of water : suspicion of swallowing disorder
- Absence of cough following administration of water : no swallowing disorder
This assessment will be compared to the ENT doctor assessment, whatever the assessment method used.
Measured: 12 months
Measure the concordance of the measurements obtained with the Deglut'G tool between two caregivers, for the detection of swallowing disorders
Inter-rater reliability of Deglut'G screening
Measured: 12 months
Estimate the average time it takes to use the Deglut'G tool
Time taken to take the Déglut'G tests (in minutes)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start12 Dec 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seendy Bartholet, PhD, Principal investigator, University Hospital Center of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163118
- Sponsor's protocol ID
- 21_RIPH2-14
- Acronym
- DéGluT'G
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Screening Tool for Swallowing Disorders for the Elderly
- ClinicalTrials.gov ID
- NCT06163118
- Acronym / sponsor ID
- DéGluT'G / 21_RIPH2-14
- Conditions
- Swallowing Disorder, Dysphagia
- Keywords
- Swallowing Disorder, Dysphagia, Swallowing Disorder test, Bronchopneumonia, Geriatric short-stay unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 8 Dec 2023 (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.
Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the mouth and the stomach, sometimes with falsities. These disorders can be the cause of a loss of appetite and a reduction in food consumption in older people.
In the most serious cases, they can lead to aspiration, weakening the pulmonary passages and possibly leading to suffocation.
Swallowing disorders constitute an important public health problem due to their prevalence among the elderly. Many early readmissions could be avoided thanks to better quality of care in these patients.
In the elderly, the number of comorbidities and the multiplicity of medications and drug intake increase the incidence of swallowing disorders in this population. They constitute a common pathology, probably underestimated and underdiagnosed in the geriatric population.
Given the aging of the Martinique population, it is appropriate to offer an easy-to-use, quickly achievable tool for diagnostic purposes, making it possible to quickly identify potential swallowing disorders, and therefore to anticipate meal intake, and on the adaptation of the prescription to a medicinal alternative (before any food or medication taken during hospitalization).
In the Geriatric Short-Stay Unit of the Martinique University Hospital, a tool called "Deglut'G", was developed, and has been used since 2015, in order to allow caregivers a rapid, reliable and relevant assessment of swallowing disorders in the elderly, in order to guide care and medication alternatives.It now appears important to validate this tool, by comparing it with the results of examinations of swallowing disorders obtained from a speech-language pathologists (SLPs) and an ENT doctor.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient aged 75 or over hospitalized in the Geriatric Short-Stay Unit | Experimental | Diagnostic Test: Deglut'G test, Diagnostic Test: SLP swallowing test, Diagnostic Test: ENT doctor swallowing testTwo caregivers from the Geriatric Short-Stay Unit will successively administer the "Deglut'G" tool to each patient, blind to each other, and blind to the SLP and ENT doctor examination. All patients will have a SLP examination and an ENT doctor examination aimed at detecting swallowing disorders. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Person aged 75 or over hospitalized in the Geriatric Short-Stay Unit,
- Person having been informed of the research,
- Person having given free written and informed consent,
- Person affiliated to a social security scheme.
Key exclusion criteria (4 listed)
- Person unable to take the tests,
- Person with an oral condition that hinders normal swallowing (stomatitis, gingivitis, etc.),
- Elderly person under legal protection, under guardianship or curatorship,
- Person who refused to participate in the study.
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 |
|---|---|---|
| Deglut'G testTwo tests to assess swallowing disorders using the Deglut'G tool will be carried out by a nurse or a caregiver from the Geriatric Short-Stay Unit, at visit 1. The tests can be taken successively, or spaced apart by a time defined by the medical team, and will be taken blind to each other. The average test administration time will be measured during the study, but the test should not exceed 10 minutes depending on the patients. The Deglut'G tool consists of an initial administration of gelled water (1 to 3 teaspoons), to identify if a cough occurs. In the event of a cough, the oral treatment is stopped; if the cough is absent, a new step this time consists of the administration of water (1 to 3 sips). In case of cough, the food will be mixed, the liquids thickened, and the medicinal treatments crushed. If there is no cough, foods and liquids can be taken as normal. | Diagnostic test | Patient aged 75 or over hospitalized in the Geriatric Short-Stay Unit |
| SLP swallowing testAt visit 1, 1 to 2 hours after the last Deglut'G test, a second swallowing test will be carried out by a SLP according to his skills and according to his usual practice, independently of the Deglut'G tool. This test should not exceed 20-30 minutes depending on the patient. | Diagnostic test | Patient aged 75 or over hospitalized in the Geriatric Short-Stay Unit |
| ENT doctor swallowing testAt Visit 2 (day 7 +/- 3 days after the inclusion), still as part of the short-stay hospitalization, the patient will meet an ENT doctor who will carry out an examination aimed at detecting swallowing disorders, according to his usual practice, of independent of the Deglut'G tool. The examination should not exceed 20-30 minutes depending on the patient. | Diagnostic test | Patient aged 75 or over hospitalized in the Geriatric Short-Stay Unit |
Primary outcome
Measure the concordance between the results of the SLP examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders.
Time frame: 12 months
Concordance between the results of the Deglut'G test and the SLP assessment. The evaluation of a swallowing disorder via the DegluT'G tool, by the geriatric short-stay unit caregivers, will be done as follows: * Presence of cough following administration of gelled water : suspicion of swallowing disorder * Presence of cough following administration of water : suspicion of swallowing disorder * Absence of cough following administration of water : no swallowing disorder This assessment will be compared to the SLP assessment, whatever the assessment method used.
3 secondary outcomes
Measure the concordance between the results of the ENT doctor examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders
Time frame: 12 months
Measure the concordance of the measurements obtained with the Deglut'G tool between two caregivers, for the detection of swallowing disorders
Time frame: 12 months
Estimate the average time it takes to use the Deglut'G tool
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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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.
Seendy Bartholet, PhD principal investigator
University Hospital Center of Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deglut'G test, SLP swallowing test and ENT doctor swallowing test in people with Swallowing Disorder and Dysphagia, run by University Hospital Center of Martinique at 1 site 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 4 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Seendy Bartholet, PhD (05 96 55 11 76 ext. +596, seendy.bartholet@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the concordance between the results of the SLP examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders. (time frame: 12 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 11 Jan 2024.