Actively Recruiting
Modelling of Pharyngeal Laryngeal Effectiveness
Led by University Hospital, Toulouse · Updated on 2025-06-13
520
Participants Needed
4
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Toulouse
Lead Sponsor
N
National Research Agency, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to collect the signals of pharyngeal laryngeal activity through five non-invasive sensors (microphone, accelerometer, surface electromyography (EMG), nasal cannula and oximeter) in order to identify indicators of functional efficiency of swallowing, protection of the lower airways and phonation. 440 patients (subjects with swallowing disorders), spread over 4 centers and 80 healthy subjects spread over 2 centers will be recruited for the study in an interventional research study involving the prospective, multicentric and longitudinal. Pharyngolaryngeal effectiveness will be measured from 6 indicators identified by examinations or reference tests grouped into 3 functions: * swallowing: pharyngeal transport capacity (Yale Residue) and Penetration Aspiration Scale (PAS) rated by videofluoroscopy of swallowing (VFS) or flexible endoscopic evaluation of swallowing (FEES); * airway protection: cough trigger (citric acid test) and cough power (peak expiratory flow); * phonation: vocal efficiency (maximum phonation time) and velar efficiency (nasal scores). The signals obtained from the 5 sensors will be annotated. Stochastic modelling based on hidden Markov models will be used initially and followed by the implementation of deep neural networks to model indicators. For the complication's prediction algorithm, deep neural networks will also be used to evaluate signal-based methods. The expected benefits are to obtain automated recognition of pharyngeal-laryngeal effectiveness to diagnose swallowing disorders using objective and quantifiable indicators, non-invasive devices, to assess the severity of these disorders and to identify the risk of complications.
CONDITIONS
Official Title
Modelling of Pharyngeal Laryngeal Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication to perform a swallowing test due to suspected or confirmed swallowing disorder or related complications
- Ability to participate in phone follow-up for 6 months or have a caregiver who can respond
- Affiliation or beneficiary of the social security system
- Written informed consent provided by the participant or their legal representative
- For healthy volunteers: no swallowing disorder or discomfort (Deglutition Handicap Index score less than 8)
- For healthy volunteers: affiliation or beneficiary of the social security system
- For healthy volunteers: signed consent to participate
You will not qualify if you...
- Presence of skin lesions on the neck
- Having a tracheotomy, tracheostomy, or laryngectomy
- Use of a nasogastric feeding tube
- Allergy to iodine
- Diagnosis of asthma
- Refusal or inability to undergo videofluoroscopy, nasofibroscopy, or wear the study sensors
- Any serious health or behavioral disorder posing additional risk as judged by the investigator
- Under legal protection such as guardianship or curatorship
- Pregnant or lactating women
- For healthy volunteers: medical history causing chronic or temporary swallowing impairment (e.g., oral-rhino-laryngeal cancer, neurological disease, recent upper respiratory infections)
- For healthy volunteers: swallowing disorder or discomfort with Deglutition Handicap Index score 8 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University hospital of Bordeaux
Bordeaux, France, 33000
Not Yet Recruiting
2
University hospital of Rouen
Rouen, France, 76038
Not Yet Recruiting
3
University Hospital of Toulouse
Toulouse, France, 31059
Actively Recruiting
4
University hospital of Tours
Tours, France, 37000
Actively Recruiting
Research Team
V
Virginie WOISARD, MD
CONTACT
G
Gaelle SORIANO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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