Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014710
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-04-11
Brief Title:
Modelling of Pharyngeal Laryngeal Effectiveness
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Eph-L
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 complications 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
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 complications 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
440 patients subjects with swallowing disorders spread over 4 centers and 80 healthy subjects spread over 2 centers will be recruited for the study
Research procedures
For patients with swallowing disorders
During a hospital visit as part of their care pathway patients with the criteria will be offered to participate in the research protocol The subjects who have given their written consent will then carry out their 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 For research purposes the subjects will also perform a cough and phonation test and questionnaires Other data used are collected as part of routine care
At the end of the assessment the patient will receive management advice based on the reference exams and his medical record
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
Duration of the research The first patient will be included from 2023 The inclusion period is 18 months Patients will be monitored for 6 months - 2 months after inclusion Healthy volunteers will have one visit estimated time 2H The total duration of the clinical study is expected to be 26 months
Data analysis The characteristics of the subjects as well as the various clinical indicators of swallowing and their evolution during monitoring will be described Development and validation algorithms to model the various pharyngo-laryngeal effectiveness indicators and predictive algorithms of swallowing disorders will be produced using statistical approaches and also using machine learning The signals obtained from the 5 sensors will be annotated The signals will be standardized and synchronized to allow the modelling of the sequences corresponding to the following events swallowing of food saliva cough throat clearing speech wet voice 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 complications prediction algorithm deep neural networks will also be used to evaluate signal-based methods
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
440 patients subjects with swallowing disorders spread over 4 centers and 80 healthy subjects spread over 2 centers will be recruited for the study
Research procedures
For patients with swallowing disorders
During a hospital visit as part of their care pathway patients with the criteria will be offered to participate in the research protocol The subjects who have given their written consent will then carry out their 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 For research purposes the subjects will also perform a cough and phonation test and questionnaires Other data used are collected as part of routine care
At the end of the assessment the patient will receive management advice based on the reference exams and his medical record
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
Duration of the research The first patient will be included from 2023 The inclusion period is 18 months Patients will be monitored for 6 months - 2 months after inclusion Healthy volunteers will have one visit estimated time 2H The total duration of the clinical study is expected to be 26 months
Data analysis The characteristics of the subjects as well as the various clinical indicators of swallowing and their evolution during monitoring will be described Development and validation algorithms to model the various pharyngo-laryngeal effectiveness indicators and predictive algorithms of swallowing disorders will be produced using statistical approaches and also using machine learning The signals obtained from the 5 sensors will be annotated The signals will be standardized and synchronized to allow the modelling of the sequences corresponding to the following events swallowing of food saliva cough throat clearing speech wet voice 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 complications prediction algorithm deep neural networks will also be used to evaluate signal-based methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00054-41 | OTHER | ID-RCB | None |