Assessing swallowing disorders using non-invasive sensors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate swallowing disorders by collecting signals from five non-invasive sensors, including a microphone, accelerometer, surface electromyography (EMG), nasal cannula, and oximeter. It will analyze pharyngeal-laryngeal activity to identify indicators of swallowing efficiency, airway protection, and phonation. The study will recruit 440 patients with swallowing disorders and 80 healthy subjects across multiple centers, utilizing artificial intelligence to model and assess the mechanisms of pharyngeal-laryngeal efficacy. The goal is to improve diagnostic techniques and access to care for individuals with swallowing difficulties.

Why it matters

Who can join: the full rules

Inclusion criteria for patients with swallowing disorders :

* Indication to perform a swallowing test (suspected or proven swallowing disorder or presence of a complication)
* Able to follow up by phone for 6 months or have a caregiver who can answer for them
* Affiliated subject or beneficiary of the social security system
* Consent to participate obtained in writing and signed by the subject or, if applicable, the next of kin/support person

Inclusion criteria for healthy volunteers :

* No swallowing disorder or discomfort (DHI score\<8)
* Affiliated subject or beneficiary of the social security system
* Signed Consent to Participate

Non-inclusion criteria for patients with swallowing disorders :

* Skin lesion(s) at the neck
* Tracheotomy or tracheostomy (laryngectomy)
* Nasogastric probe
* Iodine allergy
* Asthma
* Refusal or any pathology incompatible with passing one of the two reference exams or the sensors used
* Any serious pathology (severe health or behavioral disorders) where, according to the investigator, this could expose participants to additional risks
* Legal protection (guardianship, curators, safeguarding of justice)
* Pregnant and lactating women

Non-inclusion criteria for healthy volunteers :

* Medical history may result in chronic (history of oral-rhino-laryngeal cancer or neurological disease) or temporary (upper respiratory tract infections) swallowing impairment
* Presence of swallowing disorder or discomfort (Deglutition Handicap Index score superior or equal to 8)
* Skin lesion(s) at the neck
* Tracheotomy or tracheostomy (laryngectomy)
* Nasogastric probe
* Iodine allergy
* Asthma
* Refusal or any pathology incompatible with passing one of the two reference exams or the sensors used
* Any serious pathology (severe health or behavioral disorders) where, according to the investigator, this could expose participants to additional risks
* Legal protection (guardianship, curators, safeguarding of justice)
* Pregnant and lactating women

Where it's running

• University Hospital of Toulouse
  Toulouse, France Recruiting
• University hospital of Tours
  Tours, France Recruiting
• University hospital of Bordeaux
  Bordeaux, France Not yet recruiting
• University hospital of Rouen
  Rouen, France Not yet recruiting

Study contacts

• Principal investigator: Virginie WOISARD, MD — University Hospital of Toulouse
• Study coordinator: Virginie WOISARD, MD
• Email: woisard.v@chu-toulouse.fr
• Phone: 33-567771718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.