Development and Assessment of a New Ultrasound Score to Diagnose Swallowing Disorders in at Risk-out-patients
Phase: NA
Conditions: Deglutition Disorders
Sponsor: Hopital Forcilles

 
DARC-VADOC 
 
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Construction and assessment of a new ultrasound score for the 
swallowing disorders diagnosis in at-risk patients 
 
DARC-VADOC 
Diagnostic AccuRaCy eValuation of AeroDigestive ultrasOund sCore 
 
Version n°2 of 18/12/2020 
Protocol code 
number 
RCB ID1 
IRB NUMBER 
CNIL or MR 
number 
No. Clinical 
Trial 
2020-10-1 
2020-A02942-37 
20.12.88 / SI 
CNRIPH 
20.10.27.43604 
MR001 
<...> 
 
Interventional research involving humans with minimal risk and minimal burden (Type 
2 HIPR) 
 
PRINCIPAL INVESTIGATOR 
Natacha BOURRY, radiotherapist, Forcilles Hospital, radiotherapy department 
CO-INVESTIGATORS 
Carlos DIAZ LOPEZ, Physiotherapist, MSc, Forcilles 
Hospital, Rehabilitation Department 
Andreia GOMES LOPES, Physiotherapist, MSc, 
Forcilles Hospital, Rehabilitation Department 
Joséphine COTTIAS, physiotherapist, 
 Forcilles Hospital, Rehabilitation Department 
Aymeric LE NEINDRE, physiotherapist, PhD, clinical 
research commission, Forcilles Hospital 
Estelle ROBIN, speech therapist, Forcilles Hospital, 
rehabilitation department 
Bénédicte SINGLAND, Head of Department, ENT 
Oncology, Forcilles Hospital 
METHODOLOGY-STATISTICS 
Aymeric LE NEINDRE, PhD, Clinical research unit, Forcilles Hospital 
 
Promoter : 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 
77150 Férolles-Attilly 
Contact: 
Aymeric LE NEINDRE, Clinical Research Coordinator 
Tel: 01 60 64 61 31 
Mail: aleneindre@cognacq-jay.fr  
                                               
 

 
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KEY CONTACTS 
FIRST NAME, LAST 
NAME 
ROLE 
FUNCTION 
CONTACT INFORMATION 
Natacha BOURRY 
Principal 
investigator 
Radiotherapist 
nbourry@cognacq-jay.fr 
01.60.64.62.06 
Carlos DIAZ LOPEZ 
Co-investigator 
Head 
of 
Physiotherapy 
cdiaz.physio@gmail.com 
01.60.64.61.30 
Aymeric LE NEINDRE 
Co-investigator 
Clinical 
Research 
Coordinator 
aleneindre@cognacq-jay.fr  
01.60.64.61.31 
Andreia GOMES LOPES 
Co-investigator 
Physiotherapist 
andreialopes87@gmail.com 
06.24.92.68.03 
Joséphine COTTIAS 
Co-investigator 
Physiotherapist 
physio.jcottias@gmail.com 
06.58.88.06.10 
Estelle ROBIN 
Co-investigator 
Speech therapist 
robinestelle@orange.fr 
 
Bénédicte SINGLAND 
Co-investigator 
Head 
of 
ENT 
Oncology 
bsingland@cognacq-jay.fr  
06.60.64.61.51 
Arthur SPILLEBOUT 
Methodology 
Public health doctor 
aspillebout@cognacq-jay.fr  
01 60 64 63 78 

 
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PROTOCOL VERSION HISTORY 
 
Version 
Date 
Reason for the amendment 
N°2 
18/12/2020 
Responses to the IRB 
 
 
 
 
 
 
 
 
 

 
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SUMMARY OF THE RESEARCH 
Manager 
Forcilles Hospital-Cognacq-Jay Foundation 
Person who 
directs and 
monitors the 
research 
BOURRY Natacha 
Title 
Construction and assessment of a new ultrasound score for the swallowing 
disorders diagnosis in at-risk patients attending a day hospital 
Acronym 
DARC-VADOC 
Protocol version 
n°2 of 18/12/2020 
Rationale / 
context 
The management of swallowing disorders requires a good understanding of the 
mechanisms or structures causing the disorder. Clinical assessment lacks 
precision and diagnostic reliability. Imaging examinations, although more 
accurate, are still based on the subjective analysis of the examiner, lack 
standardisation and require human and technical resources that are often 
inaccessible to the clinician. 
In this context, ultrasound, which can be performed at the patient's bedside, is 
non-invasive, non-irradiating and allows the qualitative and quantitative 
evaluation of the different structures involved in swallowing, opens up new 
evaluation perspectives. 
Main Objective 
To construct an ultrasound score to diagnose swallowing disorders in at-risk 
patients attending a day hospital. 
Secondary 
objectives 
- 
To evaluate the validity and reliability of a new ultrasound score for the 
diagnosis of swallowing disorders. 
- 
To assess the reliability and validity of hyoid bone ascension in the 
diagnosis of swallowing disorders; 
- 
To evaluate the reliability and validity of the digastric muscle thickening 
fraction in the diagnosis of swallowing disorders; 
- 
To evaluate the reliability and validity of the genohyoid thickening fraction 
in the diagnosis of swallowing disorders; 
- 
To assess the reliability and validity of the amount and duration of lingual 
movement in the diagnosis of swallowing disorders. 
Research scheme 
Prospective, monocentric, interventional cohort study with minimal risks and 
constraints falling within the scope of article L.1121-1 of the Public Health Code. 
Inclusion criteria 
- 
Patients admitted to the day hospital ; 
- 
Patients with a medical indication for videofluoroscopy; 
- 
Medical prescription for physiotherapy assessment; 
- 
Ultrasound operator available; 
- 
Patient at least 18 years old at the time of inclusion; 
- 
Affiliation with a social security scheme or beneficiary of such a scheme ; 
- 
Oral, free, informed and express consent of the patient. 
Non-inclusion 
criteria 
- 
Patient with total laryngectomy ; 
- 
Patient's refusal to participate in the study ; 
- 
Known pregnancy ; 
- 
Person subject to a legal protection measure ; 
- 
Cognitive impairment incompatible with understanding instructions; 
- 
Patient under guardianship or curatorship ; 

 
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- 
Patient in care limitation. 
Primary endpoint 
Selection of the variables composing the score based on their diagnostic accuracy 
and their contribution to the predictive model. 
Secondary 
evaluation criteria 
- 
To evaluate the reproducibility and diagnostic accuracy of the ultrasound 
score in the diagnosis of swallowing disorders; 
- 
To evaluate the reproducibility and diagnostic accuracy of hyoid bone 
ascension in the diagnosis of swallowing disorders; 
- 
To evaluate the reproducibility and diagnostic accuracy of the digastric 
muscle thickening fraction in the diagnosis of swallowing disorders; 
- 
To evaluate the reproducibility and diagnostic accuracy of the genohyoid 
thickening fraction in the diagnosis of swallowing disorders; 
- 
To evaluate the reproducibility and diagnostic accuracy of the amount and 
duration of lingual movement in the diagnosis of swallowing disorders. 
Comparison 
groups 
Videofluoroscopy will be used as a reference examination. 
Number of 
subjects needed 
100 
Expected number 
of centres 
1 
Duration of the 
research 
25 months 
Statistical 
analysis of data 
Univariate comparisons will use the usual statistical tests after verification of the 
distribution of the variables (Chi2 or Fisher's test, t-test, anova or their non-
parametric equivalents Wilcoxon and Kruskal-Wallis tests). The ultrasound 
variables will be compared between the 2 groups by the appropriate tests 
according to the type of variables (quantitative or qualitative) and their distribution. 
The selection of variables in the prediction model will be performed by multivariate 
logistic regression based on the AIC. 
The study of inter and intra-examiner reproducibility will be evaluated with the 
Kappa coefficient. The threshold of the ultrasound score defining the presence of 
swallowing disorders will be determined using ROC (Receiver Operating 
Characteristic) curve analysis. Sensitivity, specificity, positive and negative 
predictive values, positive and negative likelihood ratios and the diagnostic ODD-
Ratio will be estimated. 
Expected benefits 
We expect excellent reliability and validity of ultrasound in the diagnosis of 
swallowing disorders, which would make it possible to propose an alternative 
examination to videofluroroscopy that would be more easily performed on an 
outpatient basis, non-invasive and non-irradiating. 
Source of funding 
Forcilles Hospital-Cognacq-Jay Foundation 
Independent 
Supervisory 
Committee 
planned 
No 
 
 

 
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LIST OF ABBREVIATIONS 
 
 
DOSS 
Dysphagia Outcome and Severity Scale 
HDJ 
Day Hospital 
FEES 
Swallowing fibroscopy 
NOT 
Penetration-Aspiration Scale 
ROC 
Receiver Operating Characteristics 
SC 
Clinical score 
SRH 
Follow-up and rehabilitation care 
VFSS 
Videofluoroscopy 
 
 
 

 
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Table of contents 
PROTOCOL VERSION HISTORY........................................................................................... 3 
SUMMARY OF THE RESEARCH ........................................................................................... 4 
LIST OF ABBREVIATIONS ................................................................................................... 6 
1 
Rationale for the research ......................................................................................... 9 
1.1 
Swallowing disorders .................................................................................................... 9 
1.2 
Day hospital for swallowing disorders .......................................................................... 10 
1.3 
Diagnostic strategy for swallowing disorders ............................................................... 10 
1.3.1 
Clinical assessment ....................................................................................................... 10 
1.3.2 
Radiology and fibroscopy .............................................................................................. 11 
1.3.3 
Ultrasound assessment ................................................................................................. 12 
1.4 
Research hypothesis .................................................................................................... 13 
2 
Objective ................................................................................................................. 13 
2.1 
Main objective ............................................................................................................ 13 
2.2 
Secondary objectives ................................................................................................... 14 
3 
Judging criteria ..................................................................... Erreur ! Signet non défini. 
3.1 
Primary endpoint ........................................................................................................ 14 
3.2 
Secondary endpoint .................................................................................................... 14 
4 
Eligibility criteria ...................................................................................................... 15 
4.1 
Inclusion criteria ......................................................................................................... 15 
4.2 
Non-inclusion criteria .................................................................................................. 15 
4.3 
Recruitment procedures .............................................................................................. 15 
5 
Research design ....................................................................................................... 15 
5.1 
Type of study .............................................................................................................. 15 
5.2 
Research Diagram ....................................................................................................... 16 
5.3 
Provisional research timetable .................................................................................... 16 
5.3.1 
Study schedule ....................................................................... Erreur ! Signet non défini. 
5.4 
Location of the study ................................................................................................... 16 
6 
Description of the usual care in HDJ deglutition ....................................................... 17 
6.1 
Description of the usual course of the HDJ ................................................................... 17 
6.2 
Standard assessment procedures ................................................................................. 17 
6.2.1 
Clinical examination of swallowing ............................................................................... 17 
6.2.2 
Videofluoroscopy .......................................................................................................... 18 
7 
Evaluation procedure added by the research ........................................................... 18 
7.1 
Operator training in ultrasound ................................................................................... 18 
7.2 
Practical arrangements for the ultrasound examination ............................................... 19 
7.3 
Aerodigestive tract ultrasound semiology .................................................................... 20 
8 
Conduct of the research ........................................................................................... 21 
8.1 
Pre-inclusion visit ........................................................................................................ 21 

 
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8.1.1 
Checking inclusion and non-inclusion criteria .............................................................. 21 
8.1.2 
Patient information and consent .................................................................................. 21 
8.2 
Inclusion visit .............................................................................................................. 21 
8.3 
Ultrasound operator visit ............................................................................................ 22 
8.4 
Visit of the speech therapist ........................................................................................ 22 
8.5 
Performance of imaging examinations ......................................................................... 22 
8.6 
End of research visit .................................................................................................... 22 
8.7 
Summary table ............................................................................................................ 23 
9 
Statistical aspects .................................................................................................... 24 
9.1 
Calculation of study size .............................................................................................. 24 
9.2 
General aspects ........................................................................................................... 24 
9.3 
Potential ultrasound score variables ............................................................................ 25 
9.4 
Determination of classes and thresholds for quantitative variables .............................. 25 
9.5 
Selection of variables to be included in the score ......................................................... 26 
9.6 
Weighting of variables ................................................................................................. 26 
9.7 
Score validation .......................................................................................................... 26 
9.7.1 
Reliability ....................................................................................................................... 26 
9.7.2 
Validity .......................................................................................................................... 26 
10 
Expected results in terms of scientific and professional advances ......................... 27 
11 
Expected benefits and risks for patients ............................................................... 27 
11.1 
Minimal risks and constraints added by the research ................................................... 27 
11.2 
Expected benefits for the patient ................................................................................. 27 
12 
Feasibility ............................................................................................................. 28 
13 
Ethical and regulatory aspects .............................................................................. 28 
13.1 
Role of the promoter ................................................................................................... 28 
13.2 
Submission to the PPC ................................................................................................. 29 
13.3 
Data protection ........................................................................................................... 29 
13.4 
Insurance .................................................................................................................... 29 
13.5 
Substantial amendment to the protocol ....................................................................... 30 
13.6 
Information notice and express consent ...................................................................... 31 
13.7 
Expected deadline for publication of results in an international journal ........................ 31 
13.8 
Data management ....................................................................................................... 32 
13.9 
Human and financial resources .................................................................................... 32 
13.10 
Data properties ....................................................................................................... 32 
14 
Bibliographic References ...................................................................................... 33 
15 
APPENDICES ......................................................................................................... 38 
15.1 
Appendix 1: Dysphagia Outcome and Severity Scale ..................................................... 39 
15.2 
Appendix 2: Penetration-aspiration scale ..................................................................... 40 
15.3 
Appendix 3: Procedure for performing Videofluoroscopy ............................................. 41 
15.4 
Appendix 4: Details of how the ultrasound measurements were taken ......................... 45 
15.5 
Annex 5. Information note to the patient ..................................................................... 47 
 

 
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1 Rationale for the research 
1.1 Swallowing disorders 
Swallowing is the mechanism that allows food to be grasped, prepared in the oral cavity and 
then propelled from the oropharynx to the stomach while protecting the airways. This is a 
complex semi-reflexive sensory-motor mechanism involving many functions and anatomical 
structures. It involves more than fifty muscles, six cranial pairs and cortical structures, 
including the fronto-parietal operculum, the primary sensorimotor cortex and the anterior 
insula association. (1) 
Impairment of any of these functions or structures of swallowing, whether neurological, 
muscular or mechanical, resulting in partial or total inability to transport the bolus of food to 
the lower digestive tract is called dysphagia or swallowing disorder. 
In some clinical contexts, the particularly high prevalence of these disorders motivates the 
quasi-systematic screening of patients. This is the case, for example, in intensive care, ENT 
oncology and post-stroke. (2)(3) 
The presence of swallowing disorders can lead to undernutrition, dehydration or the 
development of inhalation pneumonitis. (4)(5) These complications related to swallowing 
disorders are associated with an increase in patient morbidity and mortality, mainly in terms 
of increased length of stay, hospital costs, readmission rates and mortality. (6)(7)(8) 
The complexity of the swallowing mechanism, as well as the lack of specificity of the symptoms 
often encountered, requires a multidisciplinary assessment (9). The lack of precision of clinical 
tests will require the use of additional imaging or endoscopy. (6)(10) 
 
1.1. Background to the onset of swallowing disorders 
Swallowing disorders, although under-diagnosed (8)The prevalence of swallowing disorders, 
although under-diagnosed, can be as high as 30% in hospitalised patients. (11) This 
prevalence is particularly high in certain clinical situations such as neurological disorders or 
diseases like Parkinson's disease (80%) (12)neuromuscular diseases (80%) (13) or post-
stroke (81%) (14). In head and neck cancers, especially after surgery, the prevalence can be 
as high as 61%; (15). In intensive care, they may be the consequence of intubation, 
tracheotomies and prolonged mechanical ventilation, (16)(17)(7) or even the reason for 
admission to the intensive care unit. (18)(5) 
 

 
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1.2 Day hospital for swallowing disorders 
Dysphagia is a historically important disorder at Forcilles because of its prevalence in the 
population admitted to hospital. Various health professionals are organised around the 
multidisciplinary management of these disorders in the different departments of the hospital. 
The need to bring together this expertise, in order to meet the growing demand from 
independent professionals and other surrounding health establishments, in particular the 
geriatric, acute medicine and ENT cancer departments, led to the creation of a swallowing day 
hospital (HDJ). 
Most patients admitted to HDJ have sarcopenia, ENT cancers and/or have had long periods 
of mechanical ventilation and may still have a tracheostomy. 
The HDJ therefore welcomes patients with the risk factors described above for swallowing 
disorders. The examinations that will be carried out are prescribed by the doctor responsible 
for the medical care of the patient. 
The following equipment is available in the HDJ: an endoscopy column and the medical 
equipment necessary to monitor the patient's vital parameters; a radiology room with the 
necessary equipment for videofluoroscopy and two consultation rooms. Thus, within this HDJ, 
a doctor is involved, responsible for the unit, who ensures the medical evaluation of the patient, 
the carrying out of medical examinations when they are indicated and the submission of the 
end of hospitalisation report; a radiologist doctor who ensures the carrying out of imaging 
examinations; physiotherapists and speech therapists in charge of the clinical assessment of 
the patient and dieticians who carry out a consultation in order to detect and manage any 
undernutrition, and also to adapt the patient's diet to the food textures recommended by the 
speech therapists following their assessment. 
 
1.3 Diagnostic strategy for swallowing disorders 
1.3.1 Clinical assessment 
Clinical assessment of swallowing includes analytical evaluation of the structures involved and 
the use of composite tests or feeding trials. The clinician may also use self-report 
questionnaires to assess the patient's feelings to guide exploration. (19) 
As part of the analytical assessment, the speech and language therapist, after reading the 
medical record and interviewing the patient, assesses structures such as the lips, cheeks and 
tongue, and explores the cranial nerves and reflexes involved in swallowing. (20)(21) 
He will also assess the pharyngeal phase during palpation of the larynx and cervical 
auscultation during swallowing. (22) 

 
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For feeding trials, many standardised tests are described in the literature. They are based on 
a swallow test and the clinician's identification of signs such as coughing, oxygen desaturation 
or voice changes, which may indicate inhalation. (20) These tests differ in the amount of test 
food administered, the variability of its texture, and their methodology. 
Many studies have assessed the validity of these tests and the clinical examination for 
swallowing disorders. The majority of these studies have focused on screening in a post-stroke 
patient population, thereby validating some of these tests in this patient population. (23)(24) 
Several reviews of the literature have been carried out in recent years and all agree on the 
heterogeneity of the studies, the large number of existing assessment methods and the lack 
of a standardised test with sufficient predictive value in different populations such as 
neurological and neuromuscular diseases, cancers of the ENT sphere, in elderly subjects or 
in intensive care patients (8)(10)(13)(25). 
Furthermore, these assessments remain based on the feeding trial and do not allow for the 
diagnosis of deficiencies in the structures and functions involved in swallowing and therefore 
to orientate the therapeutic strategy. 
 
1.3.2 Radiology and fibroscopy 
The literature agrees that videofluoroscopy (VFSS) and swallowing fibroscopy are the gold 
standards for swallowing assessment. (26)(27) Different quantities and textures, which will 
evolve progressively according to the outcome of the first feeding trials, will be used to assess 
the patient's swallowing abilities.  
Real-time visualization of swallowing will allow the clinician to objectify inhalation as a sign of 
a swallowing disorder (28) and to estimate its severity by means of scores such as the 
"Dysphagia outcome and severity scale" (DOSS) or the "Penetration-Aspiration Scale" (PAS). 
(29)(30)(31) (Appendices 1 and 2). 
For VFSS, the liquids/foods administered to the patient are mixed with barium in order to follow 
the course of the food bolus. This allows the assessment of all three phases of swallowing 
and a better assessment of the oral phase compared to nasofibroscopy of swallowing (FEES). 
However, it does not allow the analysis of the anatomy of structures and requires the patient 
to be transported to an equipped room and exposed to radiation. 
The FEES, thanks to its location at the tip of the epiglottis during the examination, has the 
advantage of allowing the evaluation of tissues, possible local trauma or the presence of 
secretions. In addition, it allows the evaluation of the sensitivity of the larynx. However, this 
examination is often uncomfortable for the patient and requires the frequent use of a local 
anaesthetic which alters sensitivity. (6) Physiological movements during swallowing make it 

 
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difficult to see the vocal cords. The examiner will have to lower the fiberscope afterwards to 
look for signs of inhalation. Furthermore, there is a lack of a standardised protocol. (32) 
 
1.3.3 Ultrasound evaluation 
It allows the qualitative and quantitative assessment of the structures involved in the three 
phases of swallowing: the strength of the tongue, the kinetics of the lingual propulsion, the 
thickness of the supra- and infra-hyoid muscles at rest and during swallowing, the ascent of 
the hyoid bone and the larynx, and the mobility and diameter of the upper esophageal 
sphincter. 
The application of ultrasound in swallowing assessment has been described for many years. 
(33) It is an easy to use, reproducible, bedside tool that is non-invasive and non-irradiating. 
Ultrasound assesses the kinetics of the tongue for abnormal movements and the contractility 
and thickness of the oropharyngeal muscles to diagnose possible dysfunction. (34)(35) 
Ultrasound will allow quantitative and qualitative analysis of lingual kinetics during swallowing, 
in particular looking for abnormal movement patterns. (36)(37) 
It is also possible to quantify the movement in search of a propulsion defect. (38)(39) It also 
allows qualitative and quantitative assessment of the geniohyoid, mylohyoid and digastric 
muscles. 
The thickness of these muscles at rest and during swallowing and their echogenicity can be 
quantified.(40)(41) The measurement of the thickness of these muscles is reproducible and 
its accuracy in assessing the digastric muscles has been compared with MRI, showing a very 
good correlation. (42)(45) 
During this second phase of swallowing, it will also be possible to measure the duration and 
distance of hyoid bone elevation, reflecting laryngeal elevation. (43)(44)(45) A decrease in 
hyoid bone elevation associated with a decrease in lingual contraction capacity as seen on 
ultrasound can explain dysphagia. (46)  
Finally, ultrasound can be used to assess the displacement and diameter of opening and 
closing of the upper oesophageal sphincter (USO), allowing the detection of dysphagia related 
to USO damage. (47) 
This ultrasound evaluation will complement the clinical evaluation of reflexes, cranial pairs or 
the patient's posture or vigilance, with a quantitative analysis of the structures mentioned 
above, for which the clinical examination lacks precision and reliability and needs to be 
supplemented by complementary examinations. (48)(49) 
This quantitative, reproducible, non-invasive, non-radiating, bedside ultrasound analysis 
represents a promising tool for clinical practice to monitor patient progress.  (50)  

 
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Numerous studies have investigated the use of ultrasound as a diagnostic tool for swallowing 
disorders in different patient populations. (43)(51)(52) However, these studies are limited by 
their small size, often include healthy subjects, do not usually define a threshold value 
necessary for diagnosis and do not combine the evaluation of the different structures involved 
in swallowing. 
 
1.4 Research hypothesis 
We hypothesise that an ultrasound score is reliable and valid in the assessment of swallowing 
disorders in at-risk patients admitted to the swallowing day hospital. 
 
2 Objective 
2.1 Main objective 
The main objective of this study is to construct an ultrasound score to diagnose swallowing 
disorders in at-risk patients attending a day hospital. 
 
 
 

 
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2.2 Secondary objectives 
In at-risk patients admitted to a day hospital Swallowing : 
- To evaluate the validity and reliability of a new ultrasound score for the diagnosis of 
swallowing disorders. 
- To assess the reliability and validity of hyoid bone ascension in the diagnosis of 
swallowing disorders; 
- To evaluate the reliability and validity of the digastric muscle thickening fraction in the 
diagnosis of swallowing disorders; 
- To evaluate the reliability and validity of the genohyoid thickening fraction in the 
diagnosis of swallowing disorders; 
- To assess the reliability and validity of the amount and duration of lingual movement 
in the diagnosis of swallowing disorders. 
 
3 Outcome 
3.1 Primary outcome 
The main outcome is the selection of the variables composing the score based on their 
diagnostic accuracy and their contribution to the predictive model. 
 
3.2 Secondary outcomes 
The secondary outcomes will be : 
- 
To evaluate the diagnostic accuracy and reproducibility of the ultrasound score in the 
diagnosis of swallowing disorders 
- 
To evaluate the reproducibility and diagnostic accuracy of hyoid bone ascension in the 
diagnosis of swallowing disorders 
- 
To evaluate the reproducibility and diagnostic accuracy of the digastric muscle thickening 
fraction in the diagnosis of swallowing disorders  
- 
To evaluate the reproducibility and diagnostic accuracy of the genohyoid thickening 
fraction in the diagnosis of swallowing disorders  
- 
To evaluate the reproducibility and diagnostic accuracy of the amount and duration of 
lingual movement in the diagnosis of swallowing disorders  
 
 

 
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4 Eligibility criteria 
4.1 Inclusion criteria 
Patients with the following criteria will be included:  
- Patients admitted to the day hospital ; 
- Patients with a medical indication for videofluoroscopy ; 
- Medical prescription for physiotherapy assessment ; 
- Ultrasound operator available; 
- Patient at least 18 years old at the time of inclusion; 
- Affiliation with a social security scheme or beneficiary of such a scheme ; 
- Oral, free, informed and express consent of the patient. 
 
4.2 Non-inclusion criteria 
Patients with the following criteria will not be included:  
- Patient with total laryngectomy ; 
- Patient's refusal to participate in the study ; 
- Known pregnancy ; 
- Person subject to a legal protection measure ; 
- Cognitive impairment incompatible with understanding instructions; 
- Patient under guardianship or curatorship ; 
- Patient in care limitation. 
 
4.3 Recruitment procedures 
Patients will be recruited prospectively and consecutively in the HDJ Déglutition of the Forcilles 
Hospital, the only inclusion centre. The doctor in charge of the unit identifies the patients during 
the initial consultation. 
The number of annual admissions is 108 patients. The monthly recruitment target is 4 patients. 
 
5 Research design 
5.1 Type of study 
This is a prospective, monocentric, interventional cohort study with minimal risks and 
constraints falling within the scope of article L.1121-1 of the Public Health Code. 
The research will be conducted in accordance with the protocol. 
 

 
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5.2 Research scheme 
 
5.3 Provisional research timetable 
The recruitment period will be 25 months with a half-day follow-up of patients, for a total 
estimated study duration of 25 months. 
 
- 
Submission to IRB: November 2020 
- 
Start of inclusions: January 2021 
- 
Duration of the inclusion period: 25 months 
- 
Duration of each patient's participation: half a day 
- 
End of inclusions: February 2023 
- 
Total duration of the research: 25 months 
- 
Communication in congresses: Société de Rénimation de Langue Française ; Congrès de 
Pneumologie de Langue Française ; Journées Francophones en Kinésithérapie ; 
Association de Rééducation Oro-Maxillofaciale ; SEPAR ;  
- 
Publication: July 2023 
 
5.4 Location of the study 
The study will take place at the Forcilles Hospital, in the HDJ dedicated to the evaluation of 
swallowing disorders. 
 

 
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6 Description of the usual care in HDJ deglutition 
6.1 Description of the usual course of the HDJ 
A total of three patients can be admitted each week in this HDJ, one patient per half-day in 
each of the three half-days dedicated to it. This HDJ lasts approximately three hours and starts 
with the reception of the patient by the nurse and continues with :  
- 
Clinical examination and swallowing test (physiotherapist and speech therapist) ; 
- 
Nasofibroscopy (ENT doctor) ; 
- 
Videofluoroscopy (radiologist) ; 
- 
Dietetic consultation (dietician) ; 
- 
Medical consultation (delivery of the hospital report). 
After all investigations have been carried out and before the dietetic consultation, a 
consultation meeting is held between the doctor, the speech therapist and the dietician of the 
unit. This meeting allows the therapeutic strategy and any necessary adaptations to be 
defined. 
After the meeting, the dietician receives the patient in consultation and informs him/her of the 
recommendations necessary to maintain or recover a satisfactory nutritional status, while 
following the adaptations of the mode of feeding possibly decided in the consultation meeting. 
Finally, the patient is received by the doctor in charge of the unit who gives him the 
hospitalization report.  
All examinations and consultations are carried out within the usual framework of the HDJ 
Déglutition and are systematically prescribed by the doctor in charge. 
 
6.2 Standard assessment procedures 
6.2.1 Clinical examination of swallowing 
The speech and language therapist studies the patient's medical file and takes note of the 
reason for hospitalisation (and possibly of the swallowing disorder assessments and 
treatments carried out previously). The SLT then carries out a clinical assessment of the 
patient. 
This assessment consists of two parts: the clinical examination and the swallowing test. 
This examination consists mainly of observation and palpation of the different structures at 
rest and during active movements (praxis) and counter-resistance requested by the speech 
therapist. This allows the evaluation of :  
- 
The tone and mobility of the lips, tongue, cheeks, soft palate and temporomandibular 
joints; 
- 
Reflex and airway protection mechanisms; 

 
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- 
Cranial pairs involved in swallowing and the oro-maxillofacial sphere; 
- 
Posture and motor control of the head, cervical spine and upper limbs. 
Following these investigations, swallowing trials with different textures are routinely 
performed.(28) The speech and language therapist will look for signs of swallowing disorders 
such as coughing or voice changes. 
 
6.2.2 Videofluoroscopy 
This examination takes place in the radiology department of the Forcilles Hospital. It is the last 
examination performed by the patient. The electro-radiology manipulator (MER) carries out 
the examination on the prescription and under the supervision of the radiologist, as defined by 
the legal framework for this examination. The speech therapist is present to collect information 
useful for the assessment and the possible proposal of rehabilitation. Swallowing tests with 
different textures and quantities are carried out. The details of the order of the swallowing 
tests, the textures and quantities used are described in Annex 3.  
 
7 Evaluation procedure added by the research 
A swallowing ultrasound will be added as part of the research. 
7.1 Operator training in ultrasound 
The ultrasound examination will be performed by a physiotherapist, blind to the totality of the 
examinations performed on the patient. The details of the ultrasound examination carried out 
within the framework of the protocol can be found in appendix 4. 
The operator training is as follows: 
- 
3 days of theoretical and practical training; 
- 
More than 100 ultrasounds supervised by a radiologist; 
- 
Two years of independent practice. 
Similarly, all the physiotherapists performing the ultrasound scans are already involved in 
other research projects using lung, diaphragm and peripheral muscle ultrasound: 
https://clinicaltrials.gov/ct2/show/NCT02474797, 
https://clinicaltrials.gov/ct2/show/NCT02881814 
and 
https://clinicaltrials.gov/ct2/show/NCT04373811  
 
 

 
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7.2 Practical details of the ultrasound examination 
The examination, the details of which can be found in Appendix 4, is carried out using a 
Sonoscape Expert 2 ultrasound scanner (Digital Color Doppler Ultrasound System; 
Sonoscape medical corp. China) equipped with a linear probe (7-10 MHZ) and a convex probe 
(3-5 MHZ). Both probes will be used for each of the swallowing trials. 
In order to assess inter- and intra-examiner reliability, the tests will be performed by two 
different operators and twice by the same operator, i.e. 3 identical examinations in total, in the 
first 20 patients included. 
The duration of an examination will not exceed 15 minutes, i.e. a total duration of the 
ultrasound examination of 45 minutes for the first 20 patients (15 minutes for examination, 3 
examinations). 
The patient is in a sitting position and performs salivary swallowing attempts on request of the 
operator. 
 
The convex probe will be placed under the chin, in the sagittal plane and between the edges 
of the hyoid bone and the mandible. The acoustic shadows of these bones will allow us to 
localise the structures and centre the image. (53)(54) 
 
The following elements will be assessed: 
- 
The position of the hyoid bone at rest and during swallowing; 
- 
The thickness of the geniohyoid at rest and during swallowing; 
- 
The contractility of the tongue ; 
- 
The duration of contraction of the geniohyoid ; 
- 
The number of swallowing attempts. 
 
The linear probe will also be placed submentally, along a transverse axis, in order to 
qualitatively and quantitatively evaluate the suprahyoid muscles (55) 
Qualitative analysis will be performed using the Heckmatt Score. (56) Quantitative analysis 
will be performed by measuring the thickness of the muscles at rest and during contraction. 
These two measurements will be used to calculate its thickening fraction. The thickness of the 
muscle is calculated by quantifying the distance between the upper and lower fascia of the 
muscle. 
 
 

 
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7.3 Semiology in aerodigestive tract ultrasound 
The different dysfunctions of the structures or functions involved in swallowing can be defined 
on ultrasound by the following signs 
(1) Lingual dysfunction (53)(57)(54):  
a. Abnormal movement pattern ; 
b. Several attempts identified; 
c. Decreased range of motion ; 
d. Decrease in thickness. 
(2) Suprahyoid muscle dysfunction (58)(59)  :  
a. Decrease in signal strength ; 
b. Fat invasion and poorly defined muscle boundaries; 
c. Decrease in thickness or surface area compared to contralateral ; 
d. Decreased mobility and thickening fraction compared to contralateral. 
(3) Genohyoid dysfunction (55)(60) : 
a. Decreased thickening fraction. 
(4) Laryngeal ascension defect (60)(58) : 
a. Ascension <1.5cm. measured indirectly by assessment of hyoid bone 
ascension. 
 
 

 
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8 Conduct of the research 
8.1 Pre-inclusion visit 
8.1.1 Checking inclusion and non-inclusion criteria 
When a patient is admitted to the HDJ, the doctor in charge of the unit checks the presence 
of the inclusion criteria and the absence of the non-inclusion criteria in the medical file sent to 
him by the doctor referring the patient and in the patient's computerised file, if applicable.  
 
8.1.2 Patient information and consent 
When all the criteria allow the inclusion of the patient, the investigating physician informs the 
patient of the purpose of the study during a consultation. He/she provides the patient with all 
the information described in the information note (appendix 5) and, if necessary, obtains the 
patient's free, informed and express oral consent. This consent will be recorded in the patient's 
computerised medical record. 
 
8.2 Inclusion visit 
The inclusion visit takes place when the patient agrees to participate in the study.  The 
following data will be collected:  
(1) Basic data : 
a. Age, gender, height, weight ;  
b. Medical history : 
i. Oral language disorders ; 
ii.  Stay in intensive care: indicate if the patient required mechanical ventilation, 
tracheotomy, nasogastric tube; 
iii.  Neurological alterations/diseases: previous stroke; Parkinson's; ALS; dementia; 
iv.  Cervical, ENT or oesophageal surgery, (attach surgical report) ; 
v. Orthodontic treatment. 
(2) Information on nutritional status ;  
(3) Presence or absence of a tracheostomy at the time of the examination; 
(4) Presence or absence of a nasogastric tube at the time of the examination ; 
 
 

 
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(5) Data on care :  
a. Professional who requested hospitalization ; 
b. Diagnostic hypothesis of the referring clinician ; 
c. Information on the management of swallowing disorders ; 
d. Dietary adaptations. 
 
8.3 Visit of the ultrasound operator 
The ultrasound examination is the first examination performed in order to maintain the 
operator's ultrasound blindness. It will take place in the consultation room provided in the HDJ. 
 
8.4 Visit from the speech therapist 
This visit takes place following the ultrasound examination. Before the visit and the clinical 
examination, the speech and language therapist will read the patient's medical file. The SLT 
then carries out the clinical examination in the usual way. 
 
8.5  Performing imaging tests 
Imaging examinations will take place after the ultrasound examination and the SLT visit. They 
will be carried out in accordance with the procedure described in Appendix 3. After the 
imaging tests have been carried out and depending on the results, the speech and language 
therapist will adapt the advice on food textures to the patient.  
Following this examination and taking into account the results of the various investigations 
carried out during the day, the speech and language therapist will summarise the assessment 
and choose the dietary adaptations. The degree of severity corresponding to the DOSS scale, 
details of which are given in Appendix 1, will be noted in the observation booklet. 
 
8.6 End of research visit 
This visit takes place during the end-of-day consultation. It is carried out by the doctor in 
charge of the unit, who gives the patient the hospitalization report and ensures the 
transcription of the information in the research observation book.  
 
 

 
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8.7 Summary table 
 
Pre-
inclusion Inclusion 
Visit of the 
ultrasound 
operator 
Visit from the 
speech 
therapist 
Performing 
imaging tests 
Information for 
the patient or 
relative 
 
 
 
 
 
Collection of 
basic data (age, 
sex, BMI, 
medical history)  
 
 
 
 
 
Collection of the 
reason for 
hospitalisation in 
HDJ 
 
 
 
 
 
Collection of 
information on 
medical and 
rehabilitation 
care 
 
 
 
 
 
Clinical 
examination 
 
 
 
 
 
Ultrasound 
examination 
 
 
 
 
 
VFSS 
 
 
 
 
 
DOSS and 
PASS 
information 
 
 
 
 
 
  
 

 
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9 Statistical aspects 
9.1 Calculating the size of the study 
The calculation of the number of subjects required is based on the number of explanatory 
variables to be included in the multiple logistic regression model to construct the ultrasound 
score. The "1 variable per 10 events" rule is applied. (61) 
A total of 5 variables will be collected and analysed as described above (see 9.5), with an 
estimated prevalence of swallowing disorders of 50%. 
There are therefore potentially 5 variables to be included in the predictive model, i.e. a required 
number of 100 patients. 
 
9.2 General aspects 
Descriptive statistics will be based on means (+/- standard deviation) or medians [minimum-
maximum] depending on the distribution of quantitative variables. Qualitative variables will be 
described in terms of numbers and percentages. Univariate comparisons will use the usual 
statistical tests after verification of the distribution of the variables (Chi2 or Fisher's test, t-test, 
anova or their non-parametric equivalents Wilcoxon and Kruskal-Wallis tests).  
The tests will be performed at the 5% significance level. The 95% confidence intervals will be 
provided for each estimate. 
Measures of association between quantitative variables will be made using Pearson's or 
Spearman's correlation coefficients depending on the distribution of the data. Measures of 
association between qualitative variables will be performed using the Chi-square or Fisher test 
depending on the distribution of the data. 
The agreement between quantitative variables will be evaluated using the Bland-Altman 
method and that between qualitative variables using the Kappa coefficient. 
Calculations will be made using IBM SPSS v21 and R software (version 3.6.1, www.R-
project.org). 
 
 

 
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9.3 Potential variables of the ultrasound score 
Structures assessed 
 
Results 
Weighting 
Language 
 
 
 
 
Abnormal movement 
Yes/No 
 
 
> 1 attempt identified 
Yes/No 
 
 
Range of motion 
< threshold 
> threshold  
(only to be defined) 
 
 
Thickness 
< threshold 
> threshold 
(threshold 
to 
be 
defined) 
 
Suprahyoid muscles 
 
Signal strength 
(Heckmatt score) 
1-4 
 
 
Poorly 
defined 
fat 
involution and muscle 
boundaries 
Yes/No 
 
 
Decreased surface area 
compared 
to 
contralateral 
Surface < threshold 
(threshold 
to 
be 
defined)  
 
 
Thickening 
fraction 
compared to contralateral 
< threshold 
> threshold 
 (only to be defined) 
 
Geniohyoid 
 
Decreased 
thickening 
fraction 
< threshold 
> threshold 
(only to be defined) 
 
Laryngeal ascension 
 
Ascension 
measured 
indirectly by assessment 
of hyoid bone ascension  
< threshold 
> threshold  
(only to be defined) 
 
 
9.4 Determination of classes and thresholds of quantitative 
variables 
The hypothesis of a linear relationship between the logit of the diagnosis of swallowing 
disorders objectified by VFSS and the quantitative variable will be tested. If it is verified, the 
variable will be dichotomised. The threshold used will be determined using ROC (Receiver 

 
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Operating Characteristic) curve analysis, which will allow the threshold for which sensitivity 
and specificity are maximum to be retained. (62) 
The variables for which the hypothesis is not verified will be split into classes. (63) 
9.5 Selection of variables to be included in the score 
Patients will be classified into 2 groups according to the diagnosis obtained with VFSS: 
positive group (presence of swallowing disorders) and negative group (absence of swallowing 
disorders). The ultrasound variables will be compared between the 2 groups by appropriate 
tests according to the type of variables (quantitative or qualitative) and their distribution. The 
results of these comparisons will be used to select the ultrasound variables showing a 
difference between the 2 groups (p < 0.20) for inclusion in the multivariate logistic regression. 
(62)(63) 
 
9.6 Weighting of variables 
The previously selected ultrasound variables will be included in the model predicting the 
presence of swallowing disorders. Multiple logistic regression with variable selection using the 
Akaike information criterion (AIC) method will be used. The presence of multicollinearity 
between variables will also be investigated and the variable eliminated if necessary. 
Variables that do not improve the predictive model will thus be removed from the score. 
The scores for each variable resulting from the multivariate logistic regression will be used to 
weight each variable in the ultrasound score. (62)(63) 
 
9.7 Score validation 
9.7.1 Reliability 
With the correlation coefficient ρ= 0.80, a minimum value of the desired correlation 
coefficient ρ0 = 0.50, a number of observations k= 2, α= 0.05 and β= 0.20, the critical value 
for α from the normal distribution is 1.645 and the critical value for β from the normal 
distribution is 0.842. It is necessary to include 20 patients. 
The study of inter and intra-examiner reproducibility will be evaluated with the Kappa 
coefficient. (64) 
 
9.7.2 Validity 
The threshold of the ultrasound score defining the presence of swallowing disorders will be 
determined using Receiver Operating Characteristic (ROC) curve analysis. 

 
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Sensitivities, specificities, positive and negative predictive values and the diagnostic Odd ratio 
will be calculated to determine the diagnostic accuracy of the score. 
 
10 Expected results in terms of scientific and professional 
advances 
This study will allow the construction and evaluation of the reliability and validity of a new 
ultrasound score in the diagnosis of swallowing disorders. To our knowledge, no study has 
evaluated the performance of an ultrasound score in the diagnosis of swallowing disorders. 
The analysis of the different structures involved in swallowing will also provide knowledge on 
the impairment of the functions and structures involved in swallowing. This may allow to better 
orientate the therapeutic strategy, both medical and rehabilitation. 
Moreover, as the ultrasound examination is non-invasive, non-irradiating, can be performed 
in a simple consultation room and requires minimal cooperation from the patient, it could be 
an alternative to videofluroroscopy, currently the reference examination. 
Swallowing ultrasound could thus also be a tool for monitoring the effectiveness of the 
treatments implemented, since it can be performed frequently without adverse effects. 
The results of this study will only be applicable to a population of patients consulting a day 
hospital for suspected swallowing disorders, mostly related to ENT surgery or a prolonged 
stay in an intensive care unit. Further multicentre work and in other population categories to 
improve external validity. 
 
11 Expected benefits and risks for patients 
11.1 Minimal risks and constraints added by the research 
The risks and constraints for the patient will only be the extra time spent by the patient on the 
ultrasound. Ultrasound is a non-invasive, non-irradiating and totally painless tool. 
 
11.2 Expected benefits for the patient 
Ultrasound allows a quantitative and qualitative evaluation of the structures involved in 
swallowing disorders. It is a non-invasive, non-irradiating diagnostic tool that can be performed 
in a consultation. To our knowledge, there is no ultrasound score for the diagnosis of 
swallowing disorders. Videofluoroscopy is an irradiating examination, requiring the 
displacement of the patient and mobilizing a specialized multidisciplinary team. We expect 
excellent reliability and validity of ultrasound in the diagnosis of swallowing disorders, which 

 
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would make it possible to propose an alternative examination to videofluoroscopy that would 
be more easily performed on an outpatient basis, non-invasive and non-irradiating. 
 
12 Feasibility 
The Forcilles Hospital has a technical platform dedicated to the HDJ deglutition with a capacity 
of three patients per week, at a rate of one patient per day for three days. Given the difficulty 
of the surrounding health structures to have the human and technical resources to carry out 
the examinations proposed in this HDJ deglutition, many patients are referred to the Forcilles 
Hospital. The data relating to admissions over the last two years allow us to envisage 90 
patients over a 10-month period. 
The medical and physiotherapy team has experience in clinical research, as they are already 
involved in other ongoing research projects (https://clinicaltrials.gov/ct2/show/NCT02881814, 
https://clinicaltrials.gov/ct2/show/NCT02474797 
and 
https://clinicaltrials.gov/ct2/show/NCT04373811). 
Taking into account the inclusion and non-inclusion criteria, possible refusals of patients to 
participate in the research, potential exclusions and the recruitment experience, we estimate 
a minimum recruitment capacity of 50% of patients with risk factors for swallowing disorders 
admitted to HDJ for evaluation of these disorders, i.e. 100 patients in 25 months 
 
13 Ethical and regulatory aspects 
The Forcilles-Fondation Cognacq-Jay hospital promoter and the person(s) directing and 
supervising the research undertake to ensure that this research is carried out in accordance 
with law n°2004-806 of 9 August 2004 relating to public health policy and the regulatory 
provisions in force (articles L.1121-1, L.1121-2 and L.1121-3 of the Public Health Code. The 
data recorded during this research will be subject to computerised processing in compliance 
with law n°78-17 of 6 January 1978 relating to information technology, files and freedoms, 
amended by law n° 2018-493 of 20 June 2018 (decree n° 2018-687 of 1° August 2018) and 
order n° 2018-1125 of 12 December 2018. 
The research will be conducted in accordance with this protocol. 
 
13.1 Role of the promoter 
The research commission of the Forcilles-Fondation Cognacq-Jay hospital, promoter of this 
research, submits the file to the opinion of the relevant Comité de Protection des Personnes 

 
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(CPP) (CPP Ouest III) whose opinion will be notified in the information note intended for the 
persons concerned. 
The natural or legal person who initiates the research, manages it and ensures that it is 
financed is called the sponsor. 
 
13.2 Submission to the PPC 
This research will be submitted to a Committee for the Protection of Individuals, which will be 
drawn by lot within the framework of the "Jardé law" (article L.1121-4 of the Public Health 
Code, decree no. 2016-1537 of 16 November 2016, which came into force on 18 November 
2016). 
The opinion of the above-mentioned committee is notified in the information note intended for 
the persons concerned. A copy of this opinion and a summary of the research will be sent to 
the ANSM. 
 
13.3 Data protection 
This research is subject to law n°78-17 of 6 January 1978 relating to information technology, 
files and freedoms as amended by law n° 2018-493 of 20 June 2018 (decree n° 2018-687 of 
1 August 2018). Information on the rights of persons participating in this research (right of 
access and rectification, right to object to the transmission of data covered by professional 
secrecy likely to be used in the context of this research) is included in the information note 
intended for the patient. 
A reference methodology specific to the processing of personal data carried out in the context 
of biomedical research defined by Law 2004-806 of 9 August 2004 as falling within the scope 
of Articles L.1121-1 et seq. of the Public Health Code was updated by the CNIL in May 2018 
(Deliberation No. 2018-153 of 3 May 2018) following the publication of European Regulation 
No. 2016/679 (General Data Protection Regulation). This methodology allows a simplified 
declaration procedure when the nature of the data collected in the research is compatible with 
the list provided by the CNIL in its reference document. This study is part of the MR001 
reference methodology to which the Forcilles-Fondation Cognacq-Jay hospital has committed 
to comply. 
 
13.4 Insurance 
The Sponsor takes out insurance covering its own civil liability and that of any person involved 
in the performance of the research for the entire duration of the research, regardless of the 
nature of the links between the participants and the Sponsor (Article L.1121-10 of the Public 

 
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Health Code). The sponsor is also responsible for the compensation of the harmful 
consequences of the research for the person who undergoes it and for that of his or her 
dependents, unless it can be proved that the damage is not attributable to its fault or to that of 
any other party involved, without the possibility of invoking the act of a third party or the 
voluntary withdrawal of the person who initially agreed to undergo the research. Where the 
sponsor is not liable, the victims may be compensated under the conditions set out in Article 
L.1142-3. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability as well as that of any intervening party with the company 
SHAM for the entire duration of the research, in accordance with article L.1121-10 of the Public 
Health Code. 
 
13.5 Substantial amendment to the protocol 
The investigator or coordinator informs the research commission of the Forcilles-Fondation 
Cogacq-Jay hospital of any proposed modification of the protocol. Any substantial modification 
will be submitted by the sponsor of this research to the CPP for its opinion. 
 
 
 

 
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13.6 Information note and express consent 
In accordance with Article L.1122-1 of the Public Health Code, the information provided to the 
persons who are to be involved in the research is the subject of a written document submitted 
in advance to the personal protection committee. The ethical opinion of the CPP Ouest III has 
been requested. 
The investigator at the centre offers the patient, or a relative if the patient is incapacitated, to 
participate in the study. The investigator informs the patient orally of the terms of the study 
and gives him/her the information note. If the patient gives free, informed and express oral 
consent to participate in the protocol, the information given orally and in writing, as well as the 
collection of oral consent, will be recorded in the patient's medical record. 
In the event that a relative of the patient has given consent, as soon as possible, the patient 
will be informed of the research and asked for oral consent for the possible continuation of the 
research. 
Patients are free to participate or withdraw from the study at any time in accordance with 
Article 21 of the GDPR. Data collected until the patient withdraws consent will be used unless 
the patient expressly requests otherwise. The withdrawal of consent by the patient and the 
agreement to use or not the data previously collected will be traced in the patient's medical 
file. 
When the research is completed, the person who is to be the subject of the research may be 
informed of the overall results of the research in a manner to be specified in the information 
document. 
 
13.7 Expected deadline for publication of results in an international 
journal 
The deadline for the publication of the results is 30 months. 
 
 
 

 
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13.8 Data management 
For each subject, an identification code (corresponding to the centre number-inclusion 
number-Initial Surname-Initial First Name) will be assigned. The data collected will be 
confidential and coded (only the identification code will appear). The concordance table linking 
the assigned identification code and the participant's name will be kept by the principal 
investigator in a file with computer restricted access rights. The data will be entered into a 
password protected Excel® file held by the principal investigator. Data processing and 
statistical analysis will be carried out at the Forcilles-Fondation Cognacq-Jay hospital. 
The promoter is the owner of the data and no use or transmission to a third party can be made 
without his prior agreement. 
The specific documents of a type 2 interventional research ("Loi Jardé", decree n° 2016-1537 
of 16 November 2016, which came into force on 18 November 2016) with minimal risks and 
constraints will be archived by all parties for a period of 15 years after the end of the research. 
This indexed archive includes : 
- 
successive versions of the protocol (identified by version number and date); 
- 
correspondence ; 
- 
the inclusion list or register ; 
- 
the data collection document ; 
- 
research-specific annexes ; 
- 
the final report of the research. 
The database used for the statistical analysis must also be archived by the person responsible 
for the analysis (paper or computer). 
 
13.9 Human and financial resources 
The Forcilles-Fondation Cognacq-Jay hospital is equipped with human, material and technical 
resources to carry out this research project. 
 
13.10 Data properties 
The Forcilles-Fondation Cognacq-Jay Hospital is the owner of the data and no use or 
transmission to a third party may be made without its prior agreement. 
 
 

 
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25.  Magalhães Junior HV, Pernambuco L de A, Lima KC, Ferreira MAF. Screening for oropharyngeal 
dysphagia in older adults: A systematic review of self-reported questionnaires. Gerodontology. 
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Am. Nov 2008;19(4):769-85.  
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(ICON) on assessment of oropharyngeal dysphagia. Eur Ann Otorhinolaryngol Head Neck Dis. 
Feb 2018;135(1):S17-21.  
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videofluoroscopic and fiberoptic endoscopic swallow examinations. J Appl Res. 1 Dec 2003;3:89-
96.  
29.  Martin-Harris B, Brodsky MB, Michel Y, Castell DO, Schleicher M, Sandidge J, et al. MBS 
Measurement Tool for Swallow Impairment-MBSImp: Establishing a Standard. Dysphagia. Dec 
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30.  O'Neil KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia. 
May 1999;14(3):139-45.  
31.  Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. 
Dysphagia. 1996;11(2):93-8.  
32.  Macht M, White SD, Moss M. Swallowing Dysfunction After Critical Illness. Chest. Dec 
2014;146(6):1681-9.  
33.  Chi-Fishman G. Quantitative lingual, pharyngeal and laryngeal ultrasonography in swallowing 
research: a technical review. Clin Linguist Phon. Nov 2005;19(6-7):589-604.  

 
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34.  Nakamori M, Hosomi N, Takaki S, Oda M, Hiraoka A, Yoshikawa M, et al. Tongue thickness 
evaluation using ultrasonography can predict swallowing function in amyotrophic lateral sclerosis 
patients. Clin Neurophysiol Off J Int Fed Clin Neurophysiol. feb 2016;127(2):1669-74.  
35.  Van Den Engel-Hoek L, Lagarde M, Van Alfen N. Ultrasound of oral and masticatory muscles: 
Why every neuromuscular swallow team should have an ultrasound machine. Clin Anat N Y N. 
March 2017;30(2):183-93.  
36.  Peng C-L, Jost-Brinkmann P-G, Yoshida N, Chou H-H, Lin C-T. Comparison of tongue functions 
between mature and tongue-thrust swallowing--an ultrasound investigation. Am J Orthod 
Dentofac Orthop Off Publ Am Assoc Orthod Its Const Soc Am Board Orthod. May 
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37.  Fuhrmann RA, Diedrich PR. B-mode ultrasound scanning of the tongue during swallowing. Dento 
Maxillo Facial Radiol. Nov 1994;23(4):211-5.  
38.  Hsiao M-Y, Chang Y-C, Chen W-S, Chang H-Y, Wang T-G. Application of Ultrasonography in 
Assessing Oropharyngeal Dysphagia in Stroke Patients. Ultrasound Med Biol. 1 Sep 
2012;38(9):1522-8.  
39.  Nakamori M, Hosomi N, Takaki S, Oda M, Hiraoka A, Yoshikawa M, et al. Tongue thickness 
evaluation using ultrasonography can predict swallowing function in amyotrophic lateral sclerosis 
patients. Clin Neurophysiol Off J Int Fed Clin Neurophysiol. feb 2016;127(2):1669-74.  
40.  Feng X, Cartwright MS, Walker FO, Bargoil JH, Hu Y, Butler SG. Ultrasonographic evaluation of 
geniohyoid muscle and hyoid bone during swallowing in young adults: Ultrasound During 
Swallowing. The Laryngoscope. August 2015;125(8):1886-91.  
41.  Ogawa N, Mori T, Fujishima I, Wakabayashi H, Itoda M, Kunieda K, et al. Ultrasonography to 
Measure Swallowing Muscle Mass and Quality in Older Patients With Sarcopenic Dysphagia. J 
Am Med Dir Assoc. 2018;19(6):516-22.  
42.  Macrae PR, Jones RD, Myall DJ, Melzer TR, Huckabee M-L. Cross-Sectional Area of the Anterior 
Belly of the Digastric Muscle: Comparison of MRI and Ultrasound Measures. Dysphagia. Sep 
2013;28(3):375-80.  
43.  Komori M, Hyodo M, Gyo K. A swallowing evaluation with simultaneous videoendoscopy, 
ultrasonography and videofluorography in healthy controls. ENT J Oto-Rhino-Laryngol Its Relat 
Spec. 2008;70(6):393-8.  
44.  Huang Y-L, Hsieh S-F, Chang Y-C, Chen H-C, Wang T-G. Ultrasonographic evaluation of hyoid-
larynx approximation in dysphagic stroke patients. Ultrasound Med Biol. Jul 2009;35(7):1103-8.  
45.  Hsiao M-Y, Chang Y-C, Chen W-S, Chang H-Y, Wang T-G. Application of ultrasonography in 
assessing oropharyngeal dysphagia in stroke patients. Ultrasound Med Biol. Sep 
2012;38(9):1522-8.  
46.  Hsiao M-Y, Chang Y-C, Chen W-S, Chang H-Y, Wang T-G. Application of ultrasonography in 
assessing oropharyngeal dysphagia in stroke patients. Ultrasound Med Biol. Sep 
2012;38(9):1522-8.  
47.  Morinière S, Hammoudi K, Marmouset F, Bakhos D, Beutter P, Patat F. Ultrasound analysis of 
the upper esophageal sphincter during swallowing in the healthy subject. Eur Ann 
Otorhinolaryngol Head Neck Dis. Dec 2013;130(6):321-5.  
48.  Lagarde ML, Kamalski DM, van den Engel-Hoek L. The reliability and validity of cervical 
auscultation in the diagnosis of dysphagia: a systematic review. Clin Rehabil. Feb 2016;30(2):199-
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49.  Perren A, Zürcher P, Schefold JC. Clinical Approaches to Assess Post-extubation Dysphagia 
(PED) in the Critically Ill. Dysphagia. August 2019;34(4):475-86.  
50.  van den Engel-Hoek L, de Groot IJM, Sie LT, van Bruggen HW, de Groot S a. F, Erasmus CE, et 
al. Dystrophic changes in masticatory muscles related chewing problems and malocclusions in 
Duchenne muscular dystrophy. Neuromuscul Disord NMD. 2016;26(6):354-60.  
51.  Tomii Y, Matsuoka H, Torii T, Uehara T, Toyoda K, Minematsu K. A new ultrasound method for 
evaluating dysphagia in acute stroke patients. Int J Stroke Off J Int Stroke Soc. June 
2011;6(3):279-80.  
52.  Komori M, Hyodo M, Gyo K. A swallowing evaluation with simultaneous videoendoscopy, 
ultrasonography and videofluorography in healthy controls. ENT J Oto-Rhino-Laryngol Its Relat 
Spec. 2008;70(6):393-8.  
53.  Li C, Li J, Zhang C, Cao X, Li N, Song D, et al. Application of B+M-Mode Ultrasonography in 
Assessing Deglutitive Tongue Movements in Healthy Adults. Med Sci Monit Int Med J Exp Clin 
Res. 6 June 2015;21:1648-55.  
54.  Peng C-L, Miethke R-R, Pong S-J, Lin C-T. Investigation of Tongue Movements during 
Swallowing with M-Mode Ultrasonography. J Orofac Orthop Fortschritte Kieferorthopädie. Jan 
2007;68(1):17-25.  
55.  Feng X, Cartwright MS, Walker FO, Bargoil JH, Hu Y, Butler SG. Ultrasonographic evaluation of 
geniohyoid muscle and hyoid bone during swallowing in young adults: Ultrasound During 
Swallowing. The Laryngoscope. August 2015;125(8):1886-91.  
56.  Heckmatt JZ, Leeman S, Dubowitz V. Ultrasound imaging in the diagnosis of muscle disease. J 
Pediatr. Nov 1982;101(5):656-60.  
57.  Peng C-L, Jost-Brinkmann P-G, Yoshida N, Chou H-H, Lin C-T. Comparison of tongue functions 
between mature and tongue-thrust swallowing-an ultrasound investigation. Am J Orthod 
Dentofacial Orthop. May 2004;125(5):562-70.  
58.  Hsiao M-Y, Wahyuni LK, Wang T-G. Ultrasonography in Assessing Oropharyngeal Dysphagia. J 
Med Ultrasound. Dec 2013;21(4):181-8.  
59.  Van Den Engel-Hoek L, Lagarde M, Van Alfen N. Ultrasound of oral and masticatory muscles: 
Why every neuromuscular swallow team should have an ultrasound machine: Ultrasound of Oral 
and Masticatory Muscles. Clin Anat. March 2017;30(2):183-93.  
60.  Ahn SY, Cho KH, Beom J, Park DJ, Jee S, Nam JH. Reliability of Ultrasound Evaluation of Hyoid-
Larynx Approximation with Positional Change. Ultrasound Med Biol. May 2015;41(5):1221-5.  
61.  van Smeden M, de Groot JAH, Moons KGM, Collins GS, Altman DG, Eijkemans MJC, et al. No 
rationale for 1 variable per 10 events criteria for binary logistic regression analysis. BMC Med Res 
Methodol. 24 2016;16(1):163.  
62.  Fardet L, Galicier L, Lambotte O, Marzac C, Aumont C, Chahwan D, et al. Development and 
validation of the HScore, a score for the diagnosis of reactive hemophagocytic syndrome. Arthritis 
Rheumatol Hoboken NJ. Sep 2014;66(9):2613-20.  
63.  Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease 
classification system. Crit Care Med. Oct 1985;13(10):818-29.  
64.  Sim J, Wright CC. The Kappa Statistic in Reliability Studies: Use, Interpretation, and Sample Size 
Requirements. Phys Ther. 1 March 2005;85(3):257-68.  

 
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65.  Saucier B. Clinical Reasoning in the Health Professions, 2nd edition edited by Joy Higgs and Mark 
Jones. Butterworth-Heinemann, Oxford, 2000, 322 pages, £35-00, ISBN 0 750 63907 5. J Adv 
Nurs. 2001;35(4):631-631.  
66.  Viel É. Bien rédiger le bilan-diagnostic kinésithérapique. Elsevier Masson; 2006. 220 p.  
67.  Miller WC. Bias in Discrepant Analysis. J Clin Epidemiol. Feb 1998;51(3):219-31.  
68.  Randolph AG, Guyatt GH, Calvin JE, Doig G, Richardson WS. Understanding articles describing 
clinical prediction tools. Crit Care Med. Sep 1998;26(9):1603-1612.  
69.  Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an 
updated list of essential items for reporting diagnostic accuracy studies. BMJ [Internet]. 28 Oct 
2015 [cited 25 Aug 2020];351. Available from: https://www.bmj.com/content/351/bmj.h5527 
70.  Honest H, Khan KS. Reporting of measures of accuracy in systematic reviews of diagnostic 
literature. BMC Health Serv Res. Dec 2002;2(1):4.  
71.  Rutjes AWS, Reitsma JB, Di Nisio M, Smidt N, van Rijn JC, Bossuyt PMM. Evidence of bias and 
variation in diagnostic accuracy studies. CMAJ Can Med Assoc J J Assoc Medicale Can. 14 Feb 
2006;174(4):469-76.  
72.  DOYON F, HILL C. Evaluation of diagnostic methods. Éval Méthodes Diagn. 2001;82(2):117-25.  
73.  Xirouchaki N, Kondili E, Prinianakis G, Malliotakis P, Georgopoulos D. Impact of lung ultrasound 
on clinical decision making in critically ill patients. Intensive Care Med. Jan 2014;40(1):57-65.  
74.  Kim Y, McCullough GH. Maximum Hyoid Displacement in Normal Swallowing. Dysphagia. Sept 
2008;23(3):274-9.  
75.  Sia I, Carvajal P, Carnaby-Mann GD, Crary MA. Measurement of Hyoid and Laryngeal 
Displacement in Video Fluoroscopic Swallowing Studies: Variability, Reliability, and Measurement 
Error. Dysphagia. June 2012;27(2):192-7.  
 
 
 

 
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15 ANNEXES 
 
 

 
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15.1 Appendix 1: Dysphagia Outcome and Severity Scale  
 
Completely oral feeding: normal diet 
- 
Level 7: Normal in all situations 
- 
Level 6: Functional swallowing; with functional limitations/independent with modifications 
Modified scheme and/or adaptations 
- 
Level 5: Mild dysphagia; mild monitoring, may require restriction of one type of texture 
- 
Level 4: Mild to moderate dysphagia: intermittent monitoring, one or two restricted textures 
- 
Level 3: Moderate dysphagia: full assistance, supervision, two or more restricted textures 
Need for additional artificial nutrition 
- 
Level 2: Moderate to severe dysphagia: significant assistance or need for strategies with 
partial oral feeding (tolerates at least one texture with use of strategies) 
- 
Level 1: Severe dysphagia: no oral feeding: unable to tolerate oral intake 
 

 
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15.2 Appendix 2: Penetration-aspiration scale 
 
Category 
Score 
Description 
No penetration or 
suction 
1 
The material does not fit into the VA 
 
Penetration 
2 
The material enters the VA, remains above the vocal cords 
and is ejected from the VA 
3 
The material enters the VA, remains above the vocal cords 
and is not ejected from the VA 
4 
Material contacts the vocal cords and is ejected from the VA 
5 
Material contacts the vocal cords and is not ejected from the 
VA 
Suction 
6 
Material enters the VA, passes through the vocal cords and is 
ejected into the larynx or out of the VA 
7 
The material enters the VA, passes through the vocal cords, 
and is not ejected from the trachea despite patient effort 
8 
The material enters the VA, passes through the vocal cords 
and no ejection effort is made by the patient 
 
 

 
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15.3 Appendix 3: Procedure for performing Videofluoroscopy 
 Conduct of the examination :  
The examination must be carried out in the presence of the radiologist and the doctor and 
speech therapist responsible for the HDJ care.  
All professionals will ensure that they have the necessary equipment to monitor the patient's 
vital parameters. If alterations in vital parameters, patient discomfort or any other reason for 
stopping the examination, the doctor will fill in the adverse event sheet.  
If the examination could not be finalised, the patient will be excluded from the protocol. The 
exclusion of the patient for non-interpretable examination will be noted in the research 
observation booklet.  
Swallowing trials will be conducted in the quantities and textures described above. The food 
will be mixed with barium to allow for vision.  
 
For each trial, we will ask the patient to take the food/liquid and swallow it after the professional 
has indicated.  
Tests 1-4 will be performed in lateral projection. Test 5 will be performed in anteroposterior 
projection.  
 
 
Patient position:  
- 
Lateral projection (trials 1-4) :  
The patient is seated and the image is oriented to find a vertical alignment of the C2-C4 
vertebrae. The anterior-inferior border of C4 and the body of the hyoid bone will be used as a 
reference for the evaluation of laryngeal movement. (74)(75).  
- 
Anteroposterior projection (try 5) :  
Again the patient will be seated, perpendicular to the rays, in a comfortable position.  
Swallowing tests of fine liquid in a glass will be performed to observe unilateral abnormalities 
(asymmetry, paralysis or paresis).  
Figure1. Example of projections and patient set-up. Taken from : "La réhabilitation de la déglutition chez l'adulte" 
Woissar-Bassols V. 

 
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 
Sequence of testing : 
 
Chronology 
of the tests 
Product 
and 
quantity 
Signs of 
disorder 
(yes/no) 
Specify the 
structure(s)/function(s) 
in deficit 
Pathophysiological 
mechanism 
PAS 
score 
1 
5ml of the 
fine liquid 
 
 
 
 
2 
5ml of the 
thick liquid 
 
 
 
 
3 
Drink 30ml 
from a 
glass 
 
 
 
 
4 
Chew and 
swallow 1 
teaspoon 
of solid 
food 
 
 
 
 
5 
Drinks 
30ml of the 
thin liquid 
from a 
glass  
 
 
 
 
 
Record, for each food trial : 
- 
The onset of swallowing disorder signs 
- 
The structure(s) suspected of causing the disorder. If the cause of the disorder has not 
been identified, the SLT will indicate "NI". 
- 
The pathophysiological mechanism identified, according to the table above 
- 
The score corresponding to the PAS scale 
 
 
 

 
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Reminder of the physiopathological mechanisms that can be demonstrated:  
 
N° 
Pathophysiological mechanism 
N° 
Pathophysiological mechanism 
1 
Anterior closure defect of the oral cavity 
7 
Failure to initiate pharyngeal time 
2 
Posterior closure defect of the oral cavity 
8 
Lingual propulsion defect 
3 
Velopharyngeal closure defect 
9 
Pharyngeal propulsion defect 
4 
Failure to initiate oral time 
10 
Failure of the tongue base to recede 
5 
Defects in the control of the food bowl 
11 
Laryngeal ascension defect 
6 
Failure to transport orally 
12 
Failure to open the SSO 
 
Reminder of the foods that can be used for each texture: Palmer et al. Dysphagia (1993) 
Category 
Examples 
Fine liquid 
Fruit juice, soda, water 
Thick liquid 
Gazpacho milshake 
Ultra thick liquid 
Yoghurt, pudding 
Mouldable solid (type A) 
Mashed potatoes, soft cookies 
Special solid (type B) 
Hamburguer 
Multitexture (type C) 
Spaghetti with meat, beef steak 
 
 
 

 
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15.4 Appendix 4: Details of the ultrasound measurements  
1. Calculation of geniohyoid thickening 
A: Position of the probe 
B: Anatomical landmarks: shadow cone produced by the mandible (M); shadow cone produced by the hyoid bone (H); tongue body (L); 
Geniohyoid (white arrows) 
C: Increase in thickness of the Geniohyoid, represented by the two symbols (+) 
2. Calculation of the movement of the hyoid bone 
 
 
 
A: Position of the probe 
B: Anatomical landmarks: shadow cone produced by the mandible (M); shadow cone produced by the hyoid bone (H); tongue body (L); 
Geniohyoid (white arrows) 
C: Calculation of the displacement of the hyoid bone by the difference between the rest position -A(X0 ;Y0 )- and the end position B(X1 ;Y1 ) 
 
3. Calculation of lingual propulsion during propulsion 
 
 
 
A: Position of the probe 
B: Anatomical landmarks: shadow cone produced by the mandible (M); shadow cone produced by the hyoid bone (H); tongue body (L); 
Geniohyoid (white arrows) 
C: In TM mode. Calculation of the movement at half the distance between the mandible and the hyoid. The amount of movement of the tongue 
is represented by the distance A-B. The duration of the movement is represented by the distance A-C.  
 
 
 
A 
A 
A 
B 
B 
B 
C 
C 
C 

 
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4. Measurement of the thickness of the suprahyoid muscles 
A: Position of the probe 
B: Frontal section of the supra-hyoidal musculature 
C: Ultrasound image of image B. The thickness of the digastric muscles is calculated by the distance between the upper and 
lower fascia 
 
 
 

 
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15.5 Annex 5. Information note given to the patient 
DARC VADOC 
"Construction and assessment of a new ultrasound score of swallowing 
disorders diagnosis in patients with risk factors attending a day hospital 
 
RCB ID: 2020-A02942-37 
 
PRINCIPAL INVESTIGATOR 
Dr Natacha BOURRY, radiotherapist 
Forcilles Hospital 
Radiotherapy Department 
Route de Servon 77150 Férolles-Attilly 
Email : nbourry@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Commission 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Telephone: 01.60.64.61.31 
Fax: 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Dear Sir or Madam, 
Dr. ..............................................., investigator of the study, working in the Deglutition Day 
Hospital of the Forcilles-Fondation Cognacq-Jay Hospital, invites you to participate in this 
research. 
Your decision to participate is entirely free and voluntary. 
Please read the information below carefully, ask any questions you may have and take as 
much time as you wish to reflect on your decision to participate in this research. 
You are admitted to the Swallowing Day Hospital because you have risk factors associated 
with swallowing disorders and you require a thorough evaluation of these disorders. The aim 
of this hospitalisation is to carry out a complete swallowing assessment. 
What is the purpose of this research? 
The aim of this research is to construct a new ultrasound score for the diagnosis of swallowing 
disorders, to measure its reliability and reproducibility, and to propose it as an alternative to 
videofluoroscopy. 
How does this research work? 

 
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As part of the usual swallowing assessment examinations that you will undergo in the 
Swallowing Day Hospital, we propose to study the structures and functions involved in 
swallowing (tongue, hyoid bone and neck muscles) using an ultrasound scan. 
The ultrasound examination is painless, non-invasive and risk-free. It is carried out by the 
physiotherapist, using the ultrasound machine, an ultrasound probe and gelled water, over a 
period of 15 minutes. In order to evaluate the reproducibility of the ultrasound measurements, 
a 2ème physiotherapist will perform the ultrasound according to the same procedure, also for a 
duration of 15 minutes. Finally, the 1er physiotherapist will repeat the ultrasound, again 
according to the same procedure, for a duration of 15 minutes. The addition of the ultrasound 
to your examinations will add up to a total of 45 minutes. This will allow us to assess whether 
the measurements made by the same operator at 2 different times or by 2 different operators 
are similar. 
 
Your constraints in this research? 
The constraints of this research consist in having 3 ultrasound scans of the neck, over a 
maximum of 45 minutes. 
 
Possible adverse effects 
As your participation in this protocol does not involve any administration of treatment other 
than that which is currently recommended or any other modification of the conventional 
management in the Swallowing Day Hospital, no adverse effects are expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
The ultrasound will be performed transcervically, i.e. by placing the probe on your neck. The 
examination is therefore non-invasive, completely painless and does not involve exposure to 
X-rays. 
Your participation in this research will not incur any additional costs compared to those you 
would have had in the usual follow-up of your disease. 
What are the expected benefits of this research? 
We expect excellent reliability and validity of ultrasound in the diagnosis of swallowing 
disorders, which would make it possible to propose an alternative examination to 
videofluroroscopy that would be more easily performed on an outpatient basis, non-invasive 
and non-irradiating. 
 
What are the conditions for participating in this study? 

 
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In order to participate in this research, you must be affiliated to or benefit from a social security 
scheme. However, your participation in this research will not result in any additional costs for 
you compared to those incurred in the usual care. 
 
Number of patients planned and duration of research? 
This research will last 25 months with a 25 month recruitment period to include 100 patients. 
 
What data is collected for the research? 
The medical data collected during this study will be processed in a computerised, coded and 
confidential manner. No information bearing your name will be provided to anyone except the 
doctor in charge of the study and authorized personnel. All the data collected will be 
confidential and coded and then analysed by the Clinical Research Commission of the 
Forcilles-Fondation Cognacq-Jay Hospital, promoter of the research. The identification list 
(correspondence between your code for the study and your identity) will be kept strictly 
confidential. 
In accordance with the regulations in force, the data will be kept until the final research report 
is produced and then archived for 15 years. 
The data controller is the promoter, Hôpital Forcilles-Fondation Cognacq-Jay, route de Servon 
77150 Férolles-Attilly. 
 
What are your rights? 
Your participation in this research is entirely free and voluntary. You have the right not to 
participate in this research. 
You cannot be included in an interventional research protocol with minimal risks and 
constraints without having been informed beforehand. Your doctor must provide you with all 
the necessary explanations concerning this research, which must comply with the provisions 
of Article 13 of European Regulation No. 2016/679 (General Data Protection Regulation, 
GDPR). In accordance with article L.1122-1 of the Public Health Code, the entire research file 
has been submitted to the CPP XXX, which issued a favourable opinion on xx/xx/xxxx. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop participating in the research at any time without justification. This will not affect 
the quality of the care and treatment provided to you or your relationship with your doctor. The 
data collected until you withdraw your consent will be used unless you expressly request it. 
Indeed, in accordance with Article 17 of the GDPR, you have the right to request the deletion 

 
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of your data already collected. The withdrawal of your consent and the agreement to use or 
not your previously collected data will be traced in your medical file. 
 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 
April 2016 (General Data Protection Regulation), you have a right of access, rectification, 
erasure or restriction of processing. You can find out more about your rights by visiting the 
CNIL website https://www.cnil.fr/fr/reglement-europeen-protection-donnees/chapitre3. In 
accordance with the provisions of Article 21 of the RGPD, you also have the right to object to 
the transmission of data likely to be used in the context of this research and to be processed. 
Your request must be addressed to the Data Protection Officer of the Cognacq-Jay 
Foundation, either by e-mail to dpo@cognacq-jay.fr or by post to the address: Hôpital 
Forcilles-Fondation Cognacq-Jay, Délégué à la Protection des Données, route de Servon 
77150 Férolles-Attilly. You also have the right to lodge a complaint with the Commission 
Nationale de l'Informatique et des Libertés - CNIL (French personal data control authority, 
website: www.cnil.fr). 
In application of the provisions of article L. 1111-7 of the Public Health Code, you may also 
access all of your medical data directly or through a doctor of your choice. 
Your medical file will remain confidential and can only be consulted under the responsibility of 
the doctor in charge of your treatment, as well as by the health authorities and by persons duly 
mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and subject to 
professional secrecy. 
If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to reflect on your decision and you decide to 
participate in this research, the research information and your oral consent will be notified and 
dated in your medical file. 
 
 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
Any questions? 
 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
further information you may require before and during the research. 
 
 

 
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15.6 List of investigators 
 
 
LIST OF INVESTIGATORS 
FIRST NAME, LAST 
NAME 
ROLE 
FUNCTION 
CONTACT INFORMATION 
Natacha BOURRY 
Principal 
investigator 
Radiotherapist 
nbourry@cognacq-jay.fr 
01.60.64.62.06 
Carlos DIAZ LOPEZ 
Co-investigator 
Head 
of 
Physiotherapy 
cdiaz.physio@gmail.com 
01.60.64.61.30 
Aymeric LE NEINDRE 
Co-investigator 
Clinical 
Research 
Coordinator 
aleneindre@cognacq-jay.fr  
01.60.64.61.31 
Andreia GOMES LOPES 
Co-investigator 
Physiotherapist 
andreialopes87@gmail.com 
06.24.92.68.03 
Joséphine COTTIAS 
Co-investigator 
Physiotherapist 
physio.jcottias@gmail.com 
06.58.88.06.10 
Estelle ROBIN 
Co-investigator 
Speech therapist 
robinestelle@orange.fr 
 
Bénédicte SINGLAND 
Co-investigator 
Head 
of 
ENT 
Oncology 
bsingland@cognacq-jay.fr  
06.60.64.61.51