Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06014710

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Modelling of Pharyngeal Laryngeal Effectiveness | DecenTrialz