Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06014710

Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders

Led by University Hospital, Toulouse · Updated on 2025-06-13

520

Participants Needed

4

Research Sites

34 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

Researchers are studying swallowing disorders by collecting signals from five non-invasive sensors (microphone, accelerometer, surface electromyography, nasal cannula, and oximeter) to identify indicators of swallowing function, airway protection, and voice quality. The study aims to develop automated methods using artificial intelligence to assess swallowing efficiency, diagnose disorders, and predict complications. This research involves 440 patients with swallowing disorders and 80 healthy volunteers across multiple centers in a prospective, multicenter, and longitudinal design. Participants with swallowing disorders undergo swallowing assessments using standard exams like videofluoroscopy or nasofibroscopy while wearing the sensors. They also perform cough and phonation tests and complete questionnaires. Healthy volunteers have a similar evaluation during a single visit. Patients are followed monthly by phone for six months to monitor complications, with a final assessment at six months either in person or by phone. Throughout the study, researchers collect and analyze sensor signals synchronized with swallowing and speech events. They use statistical and machine learning methods, including deep neural networks, to model pharyngeal-laryngeal effectiveness and predict swallowing disorder severity and complication risks. Key outcome measures include swallowing safety and efficacy, cough power, voice and velar efficiency, and quality of life assessments. The study duration spans approximately 26 months, including follow-up for patients and one visit for healthy volunteers.

CONDITIONS

Brief Title

Modelling of Pharyngeal Laryngeal Effectiveness

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Patients with indication for swallowing test due to suspected or confirmed swallowing disorder or related complications
  • Ability to follow up by phone for 6 months or have a caregiver to assist
  • Affiliated with or beneficiary of social security system
  • Signed written consent to participate
  • Healthy volunteers with no swallowing disorder or discomfort (DHI score less than 8)
  • Healthy volunteers must also be affiliated with social security and provide signed consent
Not Eligible

You will not qualify if you...

  • Presence of skin lesions on the neck
  • Current tracheotomy, tracheostomy, or laryngectomy
  • Nasogastric feeding tube
  • Allergy to iodine
  • Asthma diagnosis
  • Any condition preventing passing reference swallowing exams or using sensors
  • Serious health or behavioral disorders increasing risks
  • Under legal protection (guardianship, curatorship, or judicial safeguarding)
  • Pregnant or breastfeeding women
  • Healthy volunteers with history of oral-rhino-laryngeal cancer or neurological disease
  • Healthy volunteers with upper respiratory infections or swallowing discomfort (DHI score 8 or greater)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Swallowing Evaluation

Duration - 1 day

Participants undergo a swallowing assessment using reference examinations (videofluoroscopy or nasofibroscopy) while wearing five non-invasive sensors. They also perform cough and phonation tests and complete questionnaires.

1 visit (in-person)

Monthly Monitoring

Duration - 6 months

Participants are contacted by phone once a month for 6 months to monitor the occurrence of complications related to swallowing disorders.

Monthly phone calls for 6 months

End of Study Visit

Duration - Up to 1 day

Participants complete a final swallowing examination either at the hospital or by telephone, as medically indicated.

1 visit (in-person or telephone)

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

G

Gaelle SORIANO

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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Frequently Asked Questions

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