Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 520
- Locations
- 4
- Primary Endpoint
- Power of cough
Study Overview
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.
Detailed Description
The process of swallowing is complex and difficult to assess because of its dynamic nature, the lack of specialists and the technical means necessary for its exploration. Thus, the majority of patients with swallowing disorders do not benefit from any specific instrumental evaluation yet essential to the diagnosis of different types of disorders. The precise analysis of the deficit and its causes makes it possible to guide the choice of adaptation or rehabilitation strategies, with the aim of preventing the risk of complications, mainly nutritional (malnutrition) and respiratory (pneumonia). The development of new, more accessible diagnostic techniques would improve access to care for this population. The purpose of this study is to collect the signals of pharyngeal laryngeal activity through five non-invasive sensors (microphone, accelerometer, surface EMG, nasal cannula and oximeter) in order to identify indicators of functional efficiency of swallowing, protection of the lower airways and phonation. Modelling the mechanisms of pharyngeal-laryngeal efficacy through the use of artificial intelligence would provide an automated assessment of disorders and prognostic risk of complications.
Primary objective: From the signals of 5 non-invasive sensors, model a multidimensional scale of pharyngeal-laryngeal efficiency measuring the 3 main functions of pharyngeal-larynx: swallowing function (evaluated by pharyngeal transport and closure of the larynx) ; airway protection function (evaluated by cough reflex and cough power); phonation function (evaluated by voice and velar efficiency)
Secondary Objectives:
- Develop a diagnostic model of different physiopathological mechanisms of swallowing
- Determine an algorithm that can predict the severity of these disorders based on pharyngeal efficacy indicators
- Determine an algorithm capable of predicting the risk of complications from swallowing disorders, based on modelling pharyngeal effectiveness (primary objective) and clinical data
Study design: An interventional research study involving the prospective, multicentric and longitudinal human person to develop a scale of pharyngeal-laryngeal effectiveness measured from signals from 5 non-invasive sensors. The signals will be collected from each participant using the sensors (microphone, accelerometer, nasal cannula, surface EMG and oximeter). Algorithms will be developed from these signals to predict different indicators of pharyngeal-laryngeal efficiency measured by baseline tests. The study population will include patients with swallowing disorders (to identify pathological signal patterns) and healthy volunteers (to identify non-pathological physiological patterns of swallowing mechanisms).
Study Design
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single group
- Primary Purpose
- Other
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental arm
Patients with swallowing disorders and healthy volunteers
Intervention: Swallowing evaluation (Other)
Outcomes
Primary Outcomes
Power of cough
Time Frame: Baseline
Cough power rated by peak expiratory flow in litres per minute
Swallowing safety
Time Frame: 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
Voice efficiency
Time Frame: Baseline
Vocal efficiency evaluated by maximum phonation time on the letter "a" held in seconds
Velar efficiency
Time Frame: Baseline
velar efficiency evaluated by assessment of the sentences without nasal phonemes and sentences with nasal phonemes
Lung defense reflex
Time Frame: Baseline
Cough trigger reviewed by citric acid test
Swallowing efficacy
Time Frame: 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).
Secondary Outcomes
- Self-assessment of severity of swallowing disorders(Baseline)
- General quality of life assessment(Baseline and 6 months)
- Quality of life assessment for patients with cancer(Baseline and 6 months)
- Severity of swallowing disorders assessed by oropharyngeal swallowing effectiveness scale(Baseline)
Investigators
Study Sites (4)
Identifiers
- NCT ID
- NCT06014710
- Other Study IDs
- RC31/22/0091, 2023-A00054-41
Dates
- First Submitted
- (3 years ago)
- First Posted
- (3 years ago)
- Primary Completion
- (in 6 months)
- Study Completion
- (next year)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No