NCT07792187

Brief 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. The main objective of this project is to study the relevance of an assessment of dysphagia by teleconsultation

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
42mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

3.4 years

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

telemedicinedeglutition disordersdisabled persons

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (5)

  • Evaluation of the satisfaction in the structures team

    1 month

  • Description of telemedicine treatment: feasibility

    2 weeks

  • Description of telemedicine treatment: evaluation methods

    2 weeks

  • Description of care in the hospital sector: feasibility

    1 month

  • Description of care in the hospital sector: evaluation methods

    1 month

Study Arms (1)

Patients with a deglutition disorder

EXPERIMENTAL

All participants will have deglutition disorder.

Other: Experimental procedure: swallowing assessment by telemedicineOther: Standard procedure: day hospitalization

Interventions

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.

Patients with a deglutition disorder

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).

Patients with a deglutition disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • non-movable patient
  • Pregnant woman, Woman of childbearing age without contraception
  • any contraindication to nasofibroscopy and/or fluoroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

FAM la Vitarelle

Montauban, 82 000, France

Location

MAS de Granès

Montauban, 82 000, France

Location

Mas Azure

Rieux-Volvestre, 31 310, France

Location

Larrey Hospital - Toulouse University Hospital

Toulouse, 31 059, France

Location

MAS Jean de la Fontaine

Toulouse, 31200, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Sabine Crestani

    Service ORL - Hôpital Larrey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 28, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations