Assessing swallowing disorders using non-invasive sensors
Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders
This study is testing new non-invasive sensors to see how well they can help identify swallowing problems in people with swallowing disorders compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT06014710 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with suspected or proven swallowing disorders who can participate in follow-up assessments.
Not a fit: Patients with severe health issues, tracheostomy, or other incompatible conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for swallowing disorders, enhancing patient care and outcomes.
How similar studies have performed: While the approach of using non-invasive sensors for swallowing assessment is innovative, similar studies have shown promise in improving diagnostic techniques for swallowing disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bordeaux and 3 other locations
- University hospital of Bordeaux — Bordeaux, France (Not_yet_recruiting)
- University hospital of Rouen — Rouen, France (Not_yet_recruiting)
- University Hospital of Toulouse — Toulouse, France (Recruiting)
- University hospital of Tours — Tours, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.