Modelling of Pharyngeal Laryngeal Effectiveness
ConditionSwallowing Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Swallowing evaluation
Other interventionFor 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)
Treatment groups
520 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Swallowing efficacy
Swallowing efficacy : pharyngeal transport capacity (assessed by the Yale Pharyngeal residue severity rating scale). The Yale Pharyngeal residue severity rating scale (YPRSRS) is a 5-point scale ranging from I (none) to V (severe).
Time frame
Baseline2
Swallowing safety
Swallowing Safety : the Penetration Aspiration Scale (PAS) rated by VFS (videofluoroscopy of swallowing) or FEES (flexible endoscopic evaluation of swallowing). The Penetration Aspiration Scale (PAS) is a 8-point scale ranging from 1 to 8 : 1 is considered the best and 8 the worst
Time frame
Baseline3
Lung defense reflex
Cough trigger reviewed by citric acid test
Time frame
Baseline4
Power of cough
Cough power rated by peak expiratory flow in litres per minute
Time frame
BaselineSecondary outcomes
1
Self-assessment of severity of swallowing disorders
Severity of swallowing disorders measured by patient self-assessment with visual analogic scale ranging from 1 = no severity to 10 = very severe.
Time frame
Baseline2
Severity of swallowing disorders assessed by oropharyngeal swallowing effectiveness scale
Severity of swallowing disorders measured by oropharyngeal swallowing effectiveness scale from baseline studies (FEES or VFS). The OroPharyngeal Swallowing Efficiency (OPSE) is a subjective evaluation of the severity expressed as a percentage of the bolus actually passing through the esophagus according to the formula: 100% (of the bolus introduced into the mouth) - X% of the bolus having gone astray - Y% of the bolus stagnating in the form of residue
Time frame
Baseline3
General quality of life assessment
Quality of life assessed by euroqol 5-dimension 5-level questionnaire (EQ-5D-5L). The EQ-5D-5L is questionnaire with 5 items from 1 to 5 : 1 is considered the best and 5 the worst and a scale from 100 " the best health you can imagine " to 0 " the worst health you can imagine ".
Time frame
Baseline and 6 months4
Quality of life assessment for patients with cancer
Quality of life assessed by Cancer Quality of life questionnaire (CLQ-C30) for patients with cancer. The CLQ-C30 questionnaire is composed of 30 items.
Time frame
Baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Toulouse
Lead sponsor
National Research Agency, France
Collaborator
Institut de Recherche en Informatique de Toulouse (IRIT)
Collaborator
Laboratoire parole et langage
Collaborator
Swallis Medical
Collaborator
Source ClinicalTrials.gov