RecruitingNot ApplicableNCT06014710

Modelling of Pharyngeal Laryngeal Effectiveness

Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders

Sponsor

University Hospital, Toulouse

Enrollment

520 participants

Start Date

Apr 14, 2023

Study Type

INTERVENTIONAL

Conditions

Swallowing Disorders

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria27

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

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Interventions

OTHERSwallowing evaluation

For patients with swallowing disorders: assessment of the swallowing performed according to the available reference examination (videofluoroscopy or nasofibroscopy). In parallel, they will carry the following sensors: microphone, accelerometer, surface electromyography, nasal cannula and pulse oximeter. The subjects will also perform a cough and phonation test and questionnaires. Each subject (or his caregiver) will be contacted by phone once a month for 6 months to monitor the occurrence of complications. The end of study visit at 6 months will be done either at the hospital with a new examination of the swallowing, by telephone, as medically indicated. For healthy volunteers: Only one visit is planned for the evaluation of the swallowing with the examination of nasofibroscopy and the installation of the sensors. The procedures (tests, examinations and questionnaires) will be identical to the data collection of the initial visit of patients with swallowing disorders)