Swallowing DisorderDYSPHAGING-PNCT05734586
Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric Patients [DYSPHAGING-PILOT]
A study testing EAT-10 (Eating assessment Tool) screening questionnaire and Protective measures for the upper airways in people with Swallowing Disorder and Sarcopanic Dysphagia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Swallowing Disorder, Sarcopanic Dysphagia
- What is being tested?
- EAT-10 (Eating assessment Tool) screening questionnaire and Protective measures for the upper airways
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 1 Oct 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged ≥ 70 years,
- Patient affiliated to a social security system,
- Patient hospitalized in the health sector or in a medico-social institute,
- Patient informed of the study (information leaflet provided) and having orally signified their consent to inclusion in the study.
- Patient under legal protection, guardianship or curatorship,
Who cannot join
- Patient unable to feed orally,
- Patient with an active pathology responsible for acute swallowing disorders (< 3 months) (neurodegenerative pathology with predominant motor impairment such as Charcot's disease, stroke, ENT disease).
- Patient unable to answer the questionnaire.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon Sud - Court Séjour Gériatrique
Lyon, 69495
Marion MERDINIAN, Dr, 00 33 4 78 86 56 83, marion.merdinian@chu-lyon.fr
About this study
Official title: Feasibility Study of Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric or Institutionalized Patients Aged ≥ 70 Years.
Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Awareness of the high prevalence of sarcopenic dysphagia and its serious consequences among elderly people with disabilities and hospitalized patients is recent, which explains the low rate of screening in the population concerned. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most exposed population are needed.
Two European learned societies have developed recommendations that include increased awareness of swallowing disorders, the use of screening scores, preventive measures, diagnostic standardization, and implemented interventions (rehabilitation, textural adaptation, etc.). In order to respect these recommendations, a pedagogical sheet, entitled DYSPHAGING was elaborated within our unit in a multiprofessional way in 4 steps (1 - Screen; 2 - Protect; 3 - Confirm; 4 - Rehabilitate).
This feasibility study aims to evaluate the rate of completion and the conditions for implementing steps 1 and 2 in hospital and institutional care units.
Read the detailed description
Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Awareness of the high prevalence of sarcopenic dysphagia and its serious consequences among elderly people with disabilities and hospitalized patients is recent, which explains the low rate of screening in the population concerned. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most exposed population are needed.
Two European learned societies have developed recommendations that include increased awareness of swallowing disorders, the use of screening scores, preventive measures, diagnostic standardization, and implemented interventions (rehabilitation, textural adaptation, etc.). In order to respect these recommendations, a pedagogical sheet, entitled DYSPHAGING was elaborated within our unit in a multiprofessional way in 4 steps (1 - Screen; 2 - Protect; 3 - Confirm; 4 - Rehabilitate).
This feasibility study aims to evaluate the rate of completion and the conditions for implementing steps 1 and 2 in hospital and institutional care units.
- Conditions
- Swallowing Disorder, Sarcopanic Dysphagia
- Being tested
- EAT-10 (Eating assessment Tool) screening questionnaire, Protective measures for the upper airways
- Keywords
- Prevention, Nutrition, Re-education
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAT-10 (Eating assessment Tool) screening questionnaireOther
After inclusion, issuance of the EAT-10 screening questionnaire for swallowing disorders by the healthcare team
Protective measures for the upper airwaysProcedure or surgery
In the event of an EAT ≥2 score, immediate implementation or within three days by the healthcare team of protective measures for the upper airways in 3 sectors:
1: Postural maneuvers; 2: Hygienodietetic rules; 3: Food textures
| Study group | Role | What they receive |
|---|---|---|
| DYSPHAGING Interventional group | Other | * Step 1: delivery of the EAT-10 questionnaire for swallowing disorders screening;
* Step 2: in case of EAT≥2 score, immediate implementation of upper airway protection measures in 3 areas:
1: Postural adjustments; 2 : Hygienic and dietary rules ; 3: Food textures The hypothesis is that allied health professionals in acute geriatric wards, rehabilitation units, and Long Term Care Units are able to implement the current recommendations for screening for sarcopenic dysphagia and to implement preventive measures but in a systematic way.
Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.
At the end of the study, each allied health professionals who has been involved in the care of at least one patient will fill out a satisfaction questionnaire. Receives: Other: EAT-10 (Eating assessment Tool) screening questionnaire; Procedure: Protective measures for the upper airways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of complete achievement of steps 1 and 2
The judgment criterion is validated if
- Stage 1 is performed and the EAT-10 < 2 or if
- Stage 1 is performed with an EAT-10 ≥ 2 and stage 2 is performed within 3 days after stage 1
Measured: Three days
Secondary outcomes (6)
Percentage of eligible patients refusing to participate in the study
Number of eligible patients who refused to participate in the study
Measured: 18 months
Age, gender, comorbidities (CIRS-G), autonomy (ADL, IADL), co-medications
Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.
Measured: 19 months
Rate of partial completion of the protocol
Proportion of non-performance of step 1 and/or step 2 within the time limit. Proportion of steps 2 carried out incompletely), description of the reasons
Measured: 19 months
Diagnosis of undernutrition and/or neurocognitive disorders and/or patent lung infection and/or COPD described in the patient's medical file, nutritional risk situation assessed by the Mini Nutritional Assessment® (MNA)
Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records.
Measured: 19 months
Composition and disciplines of the care team
At the end of the study, all data on the each allied health professionals will be collected on the dysphaging sheet
Measured: 19 months
Caregiver satisfaction (Likert scale).
At the end of the study, each allied health professionals who has been involved in the care of at least one patient will fill out a satisfaction questionnaire.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jun 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734586
- Sponsor's protocol ID
- 69HCL22_0474
- Acronym
- DYSPHAGING-P
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Masse-Deragon N, Tripoz-Dit-Masson S, Grehalle C, Subtil F, Rouze H, Grilot C, Merazga S, Goldet K, Durlach O, Schir S, Haution-Bitker M, Merdinian M, Falandry C. Adaptation and evaluation of a food preference assessment tool for older adults in geriatric care: the DYSPHAGING Preferences study protocol. BMJ Open. 2026 Sep 25;16(9):e120395. doi: 10.1136/bmjopen-2026-120395.
PubMed 42790906Durlach O, Tripoz-Dit-Masson S, Masse-Deragon N, Subtil F, Niasse-Sy Z, Herledan C, Guittard L, Goldet K, Merazga S, Chabert M, Suel A, Dayde D, Merdinian M, Falandry C. Feasibility of a screening and prevention procedure for risks associated with dysphagia in older patients in geriatric units: the DYSPHAGING pilot study protocol. BMJ Open. 2024 Apr 19;14(4):e081333. doi: 10.1136/bmjopen-2023-081333.
PubMed 38642998
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric or Institutionalized Patients Aged ≥ 70 Years.
- ClinicalTrials.gov ID
- NCT05734586
- Acronym / sponsor ID
- DYSPHAGING-P / 69HCL22_0474
- Conditions
- Swallowing Disorder, Sarcopanic Dysphagia
- Keywords
- Prevention, Nutrition, Re-education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 21 Feb 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.
Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Awareness of the high prevalence of sarcopenic dysphagia and its serious consequences among elderly people with disabilities and hospitalized patients is recent, which explains the low rate of screening in the population concerned. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most exposed population are needed.
Two European learned societies have developed recommendations that include increased awareness of swallowing disorders, the use of screening scores, preventive measures, diagnostic standardization, and implemented interventions (rehabilitation, textural adaptation, etc.). In order to respect these recommendations, a pedagogical sheet, entitled DYSPHAGING was elaborated within our unit in a multiprofessional way in 4 steps (1 - Screen; 2 - Protect; 3 - Confirm; 4 - Rehabilitate).
This feasibility study aims to evaluate the rate of completion and the conditions for implementing steps 1 and 2 in hospital and institutional care units.
Detailed description
Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Awareness of the high prevalence of sarcopenic dysphagia and its serious consequences among elderly people with disabilities and hospitalized patients is recent, which explains the low rate of screening in the population concerned. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most exposed population are needed.
Two European learned societies have developed recommendations that include increased awareness of swallowing disorders, the use of screening scores, preventive measures, diagnostic standardization, and implemented interventions (rehabilitation, textural adaptation, etc.). In order to respect these recommendations, a pedagogical sheet, entitled DYSPHAGING was elaborated within our unit in a multiprofessional way in 4 steps (1 - Screen; 2 - Protect; 3 - Confirm; 4 - Rehabilitate).
This feasibility study aims to evaluate the rate of completion and the conditions for implementing steps 1 and 2 in hospital and institutional care units.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DYSPHAGING Interventional group | Other | Other: EAT-10 (Eating assessment Tool) screening questionnaire, Procedure: Protective measures for the upper airways* Step 1: delivery of the EAT-10 questionnaire for swallowing disorders screening; * Step 2: in case of EAT≥2 score, immediate implementation of upper airway protection measures in 3 areas: 1: Postural adjustments; 2 : Hygienic and dietary rules ; 3: Food textures The hypothesis is that allied health professionals in acute geriatric wards, rehabilitation units, and Long Term Care Units are able to implement the current recommendations for screening for sarcopenic dysphagia and to implement preventive measures but in a systematic way. Patient characteristics will be collected at each site at the end of the study by a clinical research assistant based on their medical records. At the end of the study, each allied health professionals who has been involved in the care of at least one patient will fill out a satisfaction questionnaire. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient aged ≥ 70 years,
- Patient affiliated to a social security system,
- Patient hospitalized in the health sector or in a medico-social institute,
- Patient informed of the study (information leaflet provided) and having orally signified their consent to inclusion in the study.
- Patient under legal protection, guardianship or curatorship,
Key exclusion criteria (3 listed)
- Patient unable to feed orally,
- Patient with an active pathology responsible for acute swallowing disorders (< 3 months) (neurodegenerative pathology with predominant motor impairment such as Charcot's disease, stroke, ENT disease).
- Patient unable to answer the questionnaire.
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 |
|---|---|---|
| EAT-10 (Eating assessment Tool) screening questionnaireAfter inclusion, issuance of the EAT-10 screening questionnaire for swallowing disorders by the healthcare team | Other | DYSPHAGING Interventional group |
| Protective measures for the upper airwaysIn the event of an EAT ≥2 score, immediate implementation or within three days by the healthcare team of protective measures for the upper airways in 3 sectors: 1: Postural maneuvers; 2: Hygienodietetic rules; 3: Food textures | Procedure or surgery | DYSPHAGING Interventional group |
Primary outcome
Proportion of complete achievement of steps 1 and 2
Time frame: Three days
The judgment criterion is validated if 1. Stage 1 is performed and the EAT-10 < 2 or if 2. Stage 1 is performed with an EAT-10 ≥ 2 and stage 2 is performed within 3 days after stage 1
6 secondary outcomes
Percentage of eligible patients refusing to participate in the study
Time frame: 18 months
Age, gender, comorbidities (CIRS-G), autonomy (ADL, IADL), co-medications
Time frame: 19 months
Rate of partial completion of the protocol
Time frame: 19 months
Diagnosis of undernutrition and/or neurocognitive disorders and/or patent lung infection and/or COPD described in the patient's medical file, nutritional risk situation assessed by the Mini Nutritional Assessment® (MNA)
Time frame: 19 months
Composition and disciplines of the care team
Time frame: 19 months
Caregiver satisfaction (Likert scale).
Time frame: 19 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 42790906Masse-Deragon N, Tripoz-Dit-Masson S, Grehalle C, Subtil F, Rouze H, Grilot C, Merazga S, Goldet K, Durlach O, Schir S, Haution-Bitker M, Merdinian M, Falandry C. Adaptation and evaluation of a food preference assessment tool for older adults in geriatric care: the DYSPHAGING Preferences study protocol. BMJ Open. 2026 Sep 25;16(9):e120395. doi: 10.1136/bmjopen-2026-120395.
- Derived from this study: PubMed 38642998Durlach O, Tripoz-Dit-Masson S, Masse-Deragon N, Subtil F, Niasse-Sy Z, Herledan C, Guittard L, Goldet K, Merazga S, Chabert M, Suel A, Dayde D, Merdinian M, Falandry C. Feasibility of a screening and prevention procedure for risks associated with dysphagia in older patients in geriatric units: the DYSPHAGING pilot study protocol. BMJ Open. 2024 Apr 19;14(4):e081333. doi: 10.1136/bmjopen-2023-081333.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAT-10 (Eating assessment Tool) screening questionnaire and Protective measures for the upper airways in people with Swallowing Disorder and Sarcopanic Dysphagia, run by Hospices Civils de Lyon 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 5 inclusion and 3 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 25 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 Marion MERDINIAN, Dr (00 33 4 78 86 56 83, marion.merdinian@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of complete achievement of steps 1 and 2 (time frame: Three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734586, which also lists 2 linked publications.
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 25 Jan 2024.