Deglutition Disorders in Disabled PersonsTEDDYNCT07792187
Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized
A study testing Experimental procedure: swallowing assessment by telemedicine and Standard procedure: day hospitalization in people with Deglutition Disorders in Disabled Persons, run by University Hospital, Toulouse at 5 sites in France.
Trial summary
Swallowing disorders are common and fall within the scope of primary care (as basic, essential health services accessible to all individuals within a community). These swallowing disorders, strongly linked to the environment, do not require, in the majority of cases, a technical and intrusive evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders in Disabled Persons
- What is being tested?
- Experimental procedure: swallowing assessment by telemedicine and Standard procedure: day hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2027to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years living in a medical institution (MAS type, FAM from the ASEI network)
- Indication of a medical swallowing assessment in hospital
- Person affiliated to or beneficiary of a social security system.
- Free, informed and written consent signed by the participant or their guardian
Who cannot join
- Participation in another research including a period of exclusion still ongoing
- non-movable patient
- Pregnant woman, Woman of childbearing age without contraception
- any contraindication to nasofibroscopy and/or fluoroscopy
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
FAM la Vitarelle
Montauban, 82 000
Dounia Akrouh, 05 63 20 35 35 ext. +33, dounia.akrouh@asei.asso.fr
Dounia Akrouh
MAS de Granès
Montauban, 82 000
Dounia Akrouh, 05 63 20 35 35 ext. +33, dounia.akrouh@asei.asso.fr
Dounia Akrouh
Mas Azure
Rieux-Volvestre, 31 310
Noémie Roussel, 06 75 17 21 76 ext. +33, noemie.roussel@asei.asso.fr
Germain Huc, MD, 05 81 44 10 01 ext. +33, germain.huc@asei.asso.fr
Larrey Hospital - Toulouse University Hospital
Toulouse, 31 059
Sabine Crestani, MD, 05 67 77 81 61 ext. +33, crestani.s@chu-toulouse.fr
Virginie Woisard, PHD, 05 31 15 56 48 ext. +33, woisard.v@chu-toulouse.fr
MAS Jean de la Fontaine
Toulouse, 31200
Anne Breuillaud, 05 34 25 55 66 ext. +33, anne.breuillaud@asei.asso.fr
Gauthier Forni, 07 65 56 88 66 ext. +33, gauthier.forni@asei.asso.fr
About this study
Swallowing disorders are common and fall within the scope of primary care (as basic, essential health services accessible to all individuals within a community). These swallowing disorders, strongly linked to the environment, do not require, in the majority of cases, a technical and intrusive evaluation. The main objective of this project is to study the relevance of an assessment of dysphagia by teleconsultation
Read the detailed description
Experimental procedure: swallowing assessment by telemedicine. During this teleconsultation, the resident will do a food test under the eyes of the CHU specialists. Then an hospitalisation will be done with instrumental evaluation. To complete this visit, a teleexpertise will be scheduled approximately 1 month later.
- Being tested
- Experimental procedure: swallowing assessment by telemedicine, Standard procedure: day hospitalization
- Keywords
- telemedicine, deglutition disorders, disabled persons
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental procedure: swallowing assessment by telemedicineOther
The teleconsultation will be scheduled by the UVD programming IDE after contact by the structure team. This teleconsultation will take place in the presence of the patient's care assistant as well as medical staff (IDE, occupational therapist, physiotherapist, speech therapist, etc.) from the institution and a doctor specializing in swallowing and a speech therapist for the university hospital. The resident will do a food test under the eyes of CHU specialists. The patient will be able to test several textures (more or less solid/liquid) prepared in the center in order to be more accurate in their daily life. The meal will be in his familiar environment with his usual caregivers and tools. The CHU team will be able to interact directly with the institution's staff in order to have all the information necessary to determine their conclusions : questions, details on the patient's degree of compliance, etc.
Standard procedure: day hospitalizationOther
Treatment for swallowing disorders in the hospital sector consists of the patient coming to the university hospital or to a day hospital in order to carry out a swallowing assessment consisting of invasive examinations such as nasofibroscopy (NF), swallowing fluoroscopy (VFS) as well as eating a meal outside the patient's usual context, sometimes in the presence of other people foreign to the patient (source of distractibility and sometimes anxiety).
| Study group | Role | What they receive |
|---|---|---|
| Patients with a deglutition disorder | Experimental | All participants will have deglutition disorder. Receives: Other: Experimental procedure: swallowing assessment by telemedicine; Other: Standard procedure: day hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommendations on food textures
Recommendations regarding food textures will be assessed using the IDDSI (International Dysphagia Diet Standardization Initiative) scale during the V1 telemedicine visit and the V2 outpatient visit 15 days later.
This scale consists of 8 categories ranging from 0 ("liquid texture") to 7 ("normal texture"), which are used to assess patients' swallowing abilities.
This scale will be used to assess the recommended solid-textured diet (IDDSI 3 to 7) and liquid-textured diet (IDDSI 0 to 4).
The relevance between the results of the telemedicine and the outpatient visit will be assessed.
Measured: 1 month
Secondary outcomes (5)
Evaluation of the satisfaction in the structures team
Satisfaction will be assessed using a satisfaction questionnaire to be completed by caregivers or paramedical staff at medical facilities for the first telemedicine assessment (V1), and then by caregivers accompanying the patient for the second assessment in a hospital setting (V2).
It will consist of 8 questions answered on a scale ranging from 1 to 10. These questions will address satisfaction, the extent to which the consultation was tailored to the patient's needs and disability, the patient's dietary habits and the level of difficulty in conducting the consultation. A "free text comments" field will be available.
Measured: 1 month
Description of telemedicine treatment: feasibility
It will be assessed based on a description of how the teleconsultation (V1) is organized and the patient's care pathway, the presence of the usual caregiver during meals, a description of the difficulties encountered in evaluating feasibility and the level of discomfort during the food trial using the ECPA scale (Behavioral Scale for Non-Communicative Older Adults) (composite criterion).
The last scale is based on the observation of the patient's behavior and assesses facial expressions, movements, interactions with others and behavior during the meal. The higher the score, the more severe is the pain.
Measured: 2 weeks
Description of telemedicine treatment: evaluation methods
It will be assessed based on the description of the remote ecological evaluation, the assessment of the validity of the telemedicine examination among the various stakeholders, and the collection of data on the type of IDDSI food textures before and after treatment (composite criterion).
Measured: 2 weeks
Description of care in the hospital sector: feasibility
It will be assessed by describing the nature of the hospital visit (inpatient stay or outpatient visit), the presence of the usual caregiver, and the difficulties encountered in assessing feasibility, as well as the level of discomfort associated with medical procedures, using the ECPA scale (composite criterion).
Measured: 1 month
Description of care in the hospital sector: evaluation methods
It will be assessed based on the description of the examinations and procedures performed under optimal conditions:
- speech-language assessment
- nasofibroscopy,
- fluoroscopy of swallowing,
- consumption of a meal outside the patient's usual daily routine. For the last 3 procedures, the ECPA scale will be used. The diagnostic value of the examination will also be evaluated (composite criterion).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition Disorders in Disabled PersonsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Crestani, Principal investigator, Service ORL - Hôpital Larrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792187
- Sponsor's protocol ID
- RC31/24/0427
- Other IDs
- 2025-A02816-43
- Acronym
- TEDDY
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized
- ClinicalTrials.gov ID
- NCT07792187
- Acronym / sponsor ID
- TEDDY / RC31/24/0427
- Keywords
- telemedicine, deglutition disorders, disabled persons
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 28 Aug 2026 (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 disorders are common and fall within the scope of primary care (as basic, essential health services accessible to all individuals within a community). These swallowing disorders, strongly linked to the environment, do not require, in the majority of cases, a technical and intrusive evaluation. The main objective of this project is to study the relevance of an assessment of dysphagia by teleconsultation
Detailed description
Experimental procedure: swallowing assessment by telemedicine. During this teleconsultation, the resident will do a food test under the eyes of the CHU specialists. Then an hospitalisation will be done with instrumental evaluation. To complete this visit, a teleexpertise will be scheduled approximately 1 month later.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a deglutition disorder | Experimental | Other: Experimental procedure: swallowing assessment by telemedicine, Other: Standard procedure: day hospitalizationAll participants will have deglutition disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years living in a medical institution (MAS type, FAM from the ASEI network)
- Indication of a medical swallowing assessment in hospital
- Person affiliated to or beneficiary of a social security system.
- Free, informed and written consent signed by the participant or their guardian
Key exclusion criteria (4 listed)
- Participation in another research including a period of exclusion still ongoing
- non-movable patient
- Pregnant woman, Woman of childbearing age without contraception
- any contraindication to nasofibroscopy and/or fluoroscopy
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 |
|---|---|---|
| Experimental procedure: swallowing assessment by telemedicineThe teleconsultation will be scheduled by the UVD programming IDE after contact by the structure team. This teleconsultation will take place in the presence of the patient's care assistant as well as medical staff (IDE, occupational therapist, physiotherapist, speech therapist, etc.) from the institution and a doctor specializing in swallowing and a speech therapist for the university hospital. The resident will do a food test under the eyes of CHU specialists. The patient will be able to test several textures (more or less solid/liquid) prepared in the center in order to be more accurate in their daily life. The meal will be in his familiar environment with his usual caregivers and tools. The CHU team will be able to interact directly with the institution's staff in order to have all the information necessary to determine their conclusions : questions, details on the patient's degree of compliance, etc. | Other | Patients with a deglutition disorder |
| Standard procedure: day hospitalizationTreatment for swallowing disorders in the hospital sector consists of the patient coming to the university hospital or to a day hospital in order to carry out a swallowing assessment consisting of invasive examinations such as nasofibroscopy (NF), swallowing fluoroscopy (VFS) as well as eating a meal outside the patient's usual context, sometimes in the presence of other people foreign to the patient (source of distractibility and sometimes anxiety). | Other | Patients with a deglutition disorder |
Primary outcome
Recommendations on food textures
Time frame: 1 month
Recommendations regarding food textures will be assessed using the IDDSI (International Dysphagia Diet Standardization Initiative) scale during the V1 telemedicine visit and the V2 outpatient visit 15 days later. This scale consists of 8 categories ranging from 0 ("liquid texture") to 7 ("normal texture"), which are used to assess patients' swallowing abilities. This scale will be used to assess the recommended solid-textured diet (IDDSI 3 to 7) and liquid-textured diet (IDDSI 0 to 4). The relevance between the results of the telemedicine and the outpatient visit will be assessed.
5 secondary outcomes
Evaluation of the satisfaction in the structures team
Time frame: 1 month
Description of telemedicine treatment: feasibility
Time frame: 2 weeks
Description of telemedicine treatment: evaluation methods
Time frame: 2 weeks
Description of care in the hospital sector: feasibility
Time frame: 1 month
Description of care in the hospital sector: evaluation methods
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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.
Sabine Crestani principal investigator
Service ORL - Hôpital Larrey
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental procedure: swallowing assessment by telemedicine and Standard procedure: day hospitalization in people with Deglutition Disorders in Disabled Persons, run by University Hospital, Toulouse at 5 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 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: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Crestani, MD (05 67 77 81 61 ext. +33, crestani.s@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommendations on food textures (time frame: 1 month). 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 28 Aug 2026.