Modelling of Pharyngeal Laryngeal Effectiveness

Condition(s) studied

Investigational drug(s) / intervention(s)

Swallowing 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)

Study 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

Primary outcome measure(s)

• Swallowing efficacy — Baseline
  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).
• Swallowing safety — Baseline
  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
• Lung defense reflex — Baseline
  Cough trigger reviewed by citric acid test
• Power of cough — Baseline
  Cough power rated by peak expiratory flow in litres per minute
• Voice efficiency — Baseline
  Vocal efficiency evaluated by maximum phonation time on the letter "a" held in seconds
• Velar efficiency — Baseline
  velar efficiency evaluated by assessment of the sentences without nasal phonemes and sentences with nasal phonemes

Trial sites (4)

More University Hospital, Toulouse trials in France