Modelling of Pharyngeal Laryngeal Effectiveness

NCT06014710 | Recruiting

• 2 other identifiers: RC31/22/00912023-A00054-41
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Swallowing Disorders

Outcome Measures

Primary Outcomes (6)

• 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).

  Baseline

• 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

  Baseline

• Lung defense reflex

  Cough trigger reviewed by citric acid test

  Baseline

• Power of cough

  Cough power rated by peak expiratory flow in litres per minute

  Baseline

• Voice efficiency

  Vocal efficiency evaluated by maximum phonation time on the letter "a" held in seconds

  Baseline

• Velar efficiency

  velar efficiency evaluated by assessment of the sentences without nasal phonemes and sentences with nasal phonemes

  Baseline

Secondary Outcomes (4)

• Self-assessment of severity of swallowing disorders

  Baseline

• Severity of swallowing disorders assessed by oropharyngeal swallowing effectiveness scale

  Baseline

• General quality of life assessment

  Baseline and 6 months

• Quality of life assessment for patients with cancer

  Baseline and 6 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients with swallowing disorders and healthy volunteers

Other: Swallowing evaluation

Interventions

Swallowing evaluation OTHER

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)

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• National Research Agency, France: collaborator
• Institut de Recherche en Informatique de Toulouse (IRIT): collaborator
• Laboratoire parole et langage: collaborator
• Swallis Medical: collaborator

Study Sites (4)

University hospital of Bordeaux

Bordeaux, 33000, France

NOT YET RECRUITING

University hospital of Rouen

Rouen, 76038, France

NOT YET RECRUITING

University Hospital of Toulouse

Toulouse, 31059, France

RECRUITING

University hospital of Tours

Tours, 37000, France

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Virginie WOISARD, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie WOISARD, MD

CONTACT

33-567771718; woisard.v@chu-toulouse.fr

Gaelle SORIANO

CONTACT

soriano.g@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: August 28, 2023
• Study Start: April 14, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)