xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06014710</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/22/0091</org_study_id>
      <secondary_id>2023-A00054-41</secondary_id>
      <nct_id>NCT06014710</nct_id>
    </id_info>
    <brief_title>Modelling of Pharyngeal Laryngeal Effectiveness</brief_title>
    <acronym>Eph-L</acronym>
    <official_title>Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Research Agency, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institut de Recherche en Informatique de Toulouse (IRIT)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Laboratoire parole et langage</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Swallis Medical</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Toulouse</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to collect the signals of pharyngeal laryngeal activity through&#xD;
        five non-invasive sensors (microphone, accelerometer, surface electromyography (EMG), nasal&#xD;
        cannula and oximeter) in order to identify indicators of functional efficiency of swallowing,&#xD;
        protection of the lower airways and phonation.&#xD;
  &#xD;
        440 patients (subjects with swallowing disorders), spread over 4 centers and 80 healthy&#xD;
        subjects spread over 2 centers will be recruited for the study in an interventional research&#xD;
        study involving the prospective, multicentric and longitudinal.&#xD;
  &#xD;
        Pharyngolaryngeal effectiveness will be measured from 6 indicators identified by examinations&#xD;
        or reference tests grouped into 3 functions:&#xD;
  &#xD;
          -  swallowing: pharyngeal transport capacity (Yale Residue) and Penetration Aspiration&#xD;
             Scale (PAS) rated by videofluoroscopy of swallowing (VFS) or flexible endoscopic&#xD;
             evaluation of swallowing (FEES);&#xD;
  &#xD;
          -  airway protection: cough trigger (citric acid test) and cough power (peak expiratory&#xD;
             flow);&#xD;
  &#xD;
          -  phonation: vocal efficiency (maximum phonation time) and velar efficiency (nasal&#xD;
             scores).&#xD;
  &#xD;
        The signals obtained from the 5 sensors will be annotated. Stochastic modelling based on&#xD;
        hidden Markov models will be used initially and followed by the implementation of deep neural&#xD;
        networks to model indicators. For the complication's prediction algorithm, deep neural&#xD;
        networks will also be used to evaluate signal-based methods.&#xD;
  &#xD;
        The expected benefits are to obtain automated recognition of pharyngeal-laryngeal&#xD;
        effectiveness to diagnose swallowing disorders using objective and quantifiable indicators,&#xD;
        non-invasive devices, to assess the severity of these disorders and to identify the risk of&#xD;
        complications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The process of swallowing is complex and difficult to assess because of its dynamic nature,&#xD;
        the lack of specialists and the technical means necessary for its exploration. Thus, the&#xD;
        majority of patients with swallowing disorders do not benefit from any specific instrumental&#xD;
        evaluation yet essential to the diagnosis of different types of disorders. The precise&#xD;
        analysis of the deficit and its causes makes it possible to guide the choice of adaptation or&#xD;
        rehabilitation strategies, with the aim of preventing the risk of complications, mainly&#xD;
        nutritional (malnutrition) and respiratory (pneumonia). The development of new, more&#xD;
        accessible diagnostic techniques would improve access to care for this population. The&#xD;
        purpose of this study is to collect the signals of pharyngeal laryngeal activity through five&#xD;
        non-invasive sensors (microphone, accelerometer, surface EMG, nasal cannula and oximeter) in&#xD;
        order to identify indicators of functional efficiency of swallowing, protection of the lower&#xD;
        airways and phonation. Modelling the mechanisms of pharyngeal-laryngeal efficacy through the&#xD;
        use of artificial intelligence would provide an automated assessment of disorders and&#xD;
        prognostic risk of complications.&#xD;
  &#xD;
        Primary objective: From the signals of 5 non-invasive sensors, model a multidimensional scale&#xD;
        of pharyngeal-laryngeal efficiency measuring the 3 main functions of pharyngeal-larynx:&#xD;
        swallowing function (evaluated by pharyngeal transport and closure of the larynx) ; airway&#xD;
        protection function (evaluated by cough reflex and cough power); phonation function&#xD;
        (evaluated by voice and velar efficiency)&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          -  Develop a diagnostic model of different physiopathological mechanisms of swallowing&#xD;
  &#xD;
          -  Determine an algorithm that can predict the severity of these disorders based on&#xD;
             pharyngeal efficacy indicators&#xD;
  &#xD;
          -  Determine an algorithm capable of predicting the risk of complications from swallowing&#xD;
             disorders, based on modelling pharyngeal effectiveness (primary objective) and clinical&#xD;
             data&#xD;
  &#xD;
        Study design: An interventional research study involving the prospective, multicentric and&#xD;
        longitudinal human person to develop a scale of pharyngeal-laryngeal effectiveness measured&#xD;
        from signals from 5 non-invasive sensors. The signals will be collected from each participant&#xD;
        using the sensors (microphone, accelerometer, nasal cannula, surface EMG and oximeter).&#xD;
        Algorithms will be developed from these signals to predict different indicators of&#xD;
        pharyngeal-laryngeal efficiency measured by baseline tests. The study population will include&#xD;
        patients with swallowing disorders (to identify pathological signal patterns) and healthy&#xD;
        volunteers (to identify non-pathological physiological patterns of swallowing mechanisms).&#xD;
  &#xD;
        440 patients (subjects with swallowing disorders), spread over 4 centers and 80 healthy&#xD;
        subjects spread over 2 centers will be recruited for the study.&#xD;
  &#xD;
        Research procedures&#xD;
  &#xD;
        For patients with swallowing disorders:&#xD;
  &#xD;
        During a hospital visit as part of their care pathway, patients with the criteria will be&#xD;
        offered to participate in the research protocol. The subjects who have given their written&#xD;
        consent will then carry out their assessment of the swallowing performed according to the&#xD;
        available reference examination (videofluoroscopy or nasofibroscopy). In parallel, they will&#xD;
        carry the following sensors: microphone, accelerometer, surface electromyography, nasal&#xD;
        cannula and pulse oximeter. For research purposes, the subjects will also perform a cough and&#xD;
        phonation test and questionnaires. Other data used are collected as part of routine care.&#xD;
  &#xD;
        At the end of the assessment, the patient will receive management advice based on the&#xD;
        reference exams and his medical record.&#xD;
  &#xD;
        Each subject (or his caregiver) will be contacted by phone once a month for 6 months to&#xD;
        monitor the occurrence of complications, The end of study visit at 6 months will be done&#xD;
        either at the hospital with a new examination of the swallowing, by telephone, as medically&#xD;
        indicated.&#xD;
  &#xD;
        For healthy volunteers:&#xD;
  &#xD;
        Only one visit is planned for the evaluation of the swallowing with the examination of&#xD;
        nasofibroscopy and the installation of the sensors. The procedures (tests, examinations and&#xD;
        questionnaires) will be identical to the data collection of the initial visit of patients&#xD;
        with swallowing disorders)&#xD;
  &#xD;
        Duration of the research: The first patient will be included from 2023. The inclusion period&#xD;
        is 18 months. Patients will be monitored for 6 months (+/- 2 months) after inclusion Healthy&#xD;
        volunteers will have one visit (estimated time: 2H) The total duration of the clinical study&#xD;
        is expected to be 26 months&#xD;
  &#xD;
        Data analysis: The characteristics of the subjects as well as the various clinical indicators&#xD;
        of swallowing and their evolution during monitoring will be described. Development and&#xD;
        validation algorithms to model the various pharyngo-laryngeal effectiveness indicators and&#xD;
        predictive algorithms of swallowing disorders will be produced using statistical approaches&#xD;
        and also using machine learning. The signals obtained from the 5 sensors will be annotated.&#xD;
        The signals will be standardized and synchronized to allow the modelling of the sequences&#xD;
        corresponding to the following events: swallowing of food, saliva, cough, throat clearing,&#xD;
        speech, wet voice. Stochastic modelling based on hidden Markov models will be used initially&#xD;
        and followed by the implementation of deep neural networks to model indicators. For the&#xD;
        complication's prediction algorithm, deep neural networks will also be used to evaluate&#xD;
        signal-based methods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 14, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Swallowing efficacy</measure>
      <time_frame>Baseline</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Swallowing safety</measure>
      <time_frame>Baseline</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lung defense reflex</measure>
      <time_frame>Baseline</time_frame>
      <description>Cough trigger reviewed by citric acid test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Power of cough</measure>
      <time_frame>Baseline</time_frame>
      <description>Cough power rated by peak expiratory flow in litres per minute</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice efficiency</measure>
      <time_frame>Baseline</time_frame>
      <description>Vocal efficiency evaluated by maximum phonation time on the letter &quot;a&quot; held in seconds</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Velar efficiency</measure>
      <time_frame>Baseline</time_frame>
      <description>velar efficiency evaluated by assessment of the sentences without nasal phonemes and sentences with nasal phonemes</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-assessment of severity of swallowing disorders</measure>
      <time_frame>Baseline</time_frame>
      <description>Severity of swallowing disorders measured by patient self-assessment with visual analogic scale ranging from 1 = no severity to 10 = very severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity of swallowing disorders assessed by oropharyngeal swallowing effectiveness scale</measure>
      <time_frame>Baseline</time_frame>
      <description>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:&#xD;
  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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General quality of life assessment</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>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 &quot; the best health you can imagine &quot; to 0 &quot; the worst health you can imagine &quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life assessment for patients with cancer</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">520</enrollment>
    <condition>Swallowing Disorders</condition>
    <arm_group>
      <arm_group_label>Experimental arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with swallowing disorders and healthy volunteers</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Swallowing evaluation</intervention_name>
      <description>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.&#xD;
  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)</description>
      <arm_group_label>Experimental arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria for patients with swallowing disorders :&#xD;
  &#xD;
            -  Indication to perform a swallowing test (suspected or proven swallowing disorder or&#xD;
               presence of a complication)&#xD;
  &#xD;
            -  Able to follow up by phone for 6 months or have a caregiver who can answer for them&#xD;
  &#xD;
            -  Affiliated subject or beneficiary of the social security system&#xD;
  &#xD;
            -  Consent to participate obtained in writing and signed by the subject or, if&#xD;
               applicable, the next of kin/support person&#xD;
  &#xD;
          Inclusion criteria for healthy volunteers :&#xD;
  &#xD;
            -  No swallowing disorder or discomfort (DHI score&lt;8)&#xD;
  &#xD;
            -  Affiliated subject or beneficiary of the social security system&#xD;
  &#xD;
            -  Signed Consent to Participate&#xD;
  &#xD;
          Non-inclusion criteria for patients with swallowing disorders :&#xD;
  &#xD;
            -  Skin lesion(s) at the neck&#xD;
  &#xD;
            -  Tracheotomy or tracheostomy (laryngectomy)&#xD;
  &#xD;
            -  Nasogastric probe&#xD;
  &#xD;
            -  Iodine allergy&#xD;
  &#xD;
            -  Asthma&#xD;
  &#xD;
            -  Refusal or any pathology incompatible with passing one of the two reference exams or&#xD;
               the sensors used&#xD;
  &#xD;
            -  Any serious pathology (severe health or behavioral disorders) where, according to the&#xD;
               investigator, this could expose participants to additional risks&#xD;
  &#xD;
            -  Legal protection (guardianship, curators, safeguarding of justice)&#xD;
  &#xD;
            -  Pregnant and lactating women&#xD;
  &#xD;
          Non-inclusion criteria for healthy volunteers :&#xD;
  &#xD;
            -  Medical history may result in chronic (history of oral-rhino-laryngeal cancer or&#xD;
               neurological disease) or temporary (upper respiratory tract infections) swallowing&#xD;
               impairment&#xD;
  &#xD;
            -  Presence of swallowing disorder or discomfort (Deglutition Handicap Index score&#xD;
               superior or equal to 8)&#xD;
  &#xD;
            -  Skin lesion(s) at the neck&#xD;
  &#xD;
            -  Tracheotomy or tracheostomy (laryngectomy)&#xD;
  &#xD;
            -  Nasogastric probe&#xD;
  &#xD;
            -  Iodine allergy&#xD;
  &#xD;
            -  Asthma&#xD;
  &#xD;
            -  Refusal or any pathology incompatible with passing one of the two reference exams or&#xD;
               the sensors used&#xD;
  &#xD;
            -  Any serious pathology (severe health or behavioral disorders) where, according to the&#xD;
               investigator, this could expose participants to additional risks&#xD;
  &#xD;
            -  Legal protection (guardianship, curators, safeguarding of justice)&#xD;
  &#xD;
            -  Pregnant and lactating women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Virginie WOISARD, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Virginie WOISARD, MD</last_name>
      <phone>33-567771718</phone>
      <email>woisard.v@chu-toulouse.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gaelle SORIANO</last_name>
      <email>soriano.g@chu-toulouse.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University hospital of Bordeaux</name>
        <address>
          <city>Bordeaux</city>
          <zip>33000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Emmanuelle CUGY, MD</last_name>
      </contact>
      <investigator>
        <last_name>Emmanuelle CUGY</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University hospital of Rouen</name>
        <address>
          <city>Rouen</city>
          <zip>76038</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Eric VERIN, MD</last_name>
      </contact>
      <investigator>
        <last_name>Eric VERIN</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Hospital of Toulouse</name>
        <address>
          <city>Toulouse</city>
          <zip>31059</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Virginie WOISARD, MD</last_name>
        <email>woisard.v@chu-toulouse.fr</email>
      </contact>
      <investigator>
        <last_name>MD WOISARD, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University hospital of Tours</name>
        <address>
          <city>Tours</city>
          <zip>37000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sylvain MORINIERE</last_name>
      </contact>
      <investigator>
        <last_name>Sylvain MORINIERE</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deglutition Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06014710
  org study id: RC31/22/0091
  secondary id: 2023-A00054-41
  nct id: NCT06014710
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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
        complication's prediction algorithm, deep neural networks will also be used to evaluate
        signal-based methods.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Swallowing efficacy
  time frame: Baseline
  description: 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).
  measure: Swallowing safety
  time frame: Baseline
  description: 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
  measure: Lung defense reflex
  time frame: Baseline
  description: Cough trigger reviewed by citric acid test
  measure: Power of cough
  time frame: Baseline
  description: Cough power rated by peak expiratory flow in litres per minute
  measure: Voice efficiency
  time frame: Baseline
  description: Vocal efficiency evaluated by maximum phonation time on the letter "a" held in seconds
  measure: Velar efficiency
  time frame: Baseline
  description: velar efficiency evaluated by assessment of the sentences without nasal phonemes and sentences with nasal phonemes
  measure: Self-assessment of severity of swallowing disorders
  time frame: Baseline
  description: Severity of swallowing disorders measured by patient self-assessment with visual analogic scale ranging from 1 = no severity to 10 = very severe.
  measure: Severity of swallowing disorders assessed by oropharyngeal swallowing effectiveness scale
  time frame: Baseline
  description: 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
  measure: General quality of life assessment
  time frame: Baseline and 6 months
  description: 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 ".
  measure: Quality of life assessment for patients with cancer
  time frame: Baseline and 6 months
  description: 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.
  arm group label: Experimental arm
  arm group type: Experimental
  description: Patients with swallowing disorders and healthy volunteers
  intervention type: Other
  intervention name: Swallowing evaluation
  description: 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)
  arm group label: Experimental arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Virginie WOISARD, MD
  role: Principal Investigator
  affiliation: University Hospital of Toulouse
  last name: Virginie WOISARD, MD
  phone: 33-567771718
  email: woisard.v@chu-toulouse.fr
  last name: Gaelle SORIANO
  email: soriano.g@chu-toulouse.fr
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Deglutition Disorders