Modelling of Pharyngeal Laryngeal Effectiveness (NCT06014710) | Clinical Trial Compass
RecruitingNot Applicable
Modelling of Pharyngeal Laryngeal Effectiveness
France520 participantsStarted 2023-04-14
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 su…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.