Production et Perception émotionnelle Chez Les Patients paralysés Faciaux: Marqueurs Respiratoires, Phonatoires et expressivité Faciale.
Phase: NA
Conditions: Facial Palsy
Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Etude ResPPF_ Version n°1.0 du 06/04/2018
Emotional Perception and Production in Facial Palsy: Respiratory, Vocal 
and Facial Markers.
ResPPF 
National Clinical Trial (NCT) Identified Number:
N° ID RCB (ANSM) : 2018-A01043-52
Version 1.0 du 06/04/2018
Principal Investigator:
 Nom : Pr Peggy Gatignol
Neurophysiologie Respiratoire Expérimentale et Clinique
INSERM-UPMC UMR_S 1158
peggy.gatignol@sorbonne-universite.fr
01 40 77 96 04
Co-investigators:
Pr. Thomas Similowski
Pr. Lamas
Mme Diane Picard
Sponsor: ADOREPS 
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur 
le Sommeil
Service de Pneumologie et Réanimation Médicale 
Groupe Hospitalier Pitié-Salpêtrière 
47-83, Boulevard de l’Hôpital
75651 Paris Cedex 13
Tel : 01 42 16 77 97 
Fax : 01 70 24 72 82
Mail : bureau@adoreps.fr
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Table of Contents
1 Protocol Summary....................................................................................................................3
2 Introduction..............................................................................................................................5
2.1 Title .............................................................................................................................5
2.2 Sponsor........................................................................................................................5
2.3 Study design ...............................................................................................................5
2.4 Experimentation site....................................................................................................5
2.5 Investigateur principal.................................................................................................5
3 Scientific Rationale..................................................................................................................5
3.1 Emotions and Breathing..............................................................................................6
3.2 Emotions and Vocal production .................................................................................6
3.3 Emotions and facial expressivity.................................................................................6
4 Objectives.................................................................................................................................7
4.1.1 Main Outcome.................................................................................................7
4.1.2 Secondary Outcomes.......................................................................................7
5 Study Design............................................................................................................................7
5.1 Study Duration.............................................................................................................7
5.2 Définition de la population étudiée.............................................................................7
5.2.1 Critères d'inclusion..........................................................................................7
5.2.2 Critères de non-inclusion................................................................................8
5.3 Methods.......................................................................................................................8
5.3.1 Schedule of activities......................................................................................8
5.3.2 Collecting Data................................................................................................9
5.3.3 Endpoints.......................................................................................................10
5.3.3.1 Main outcome...................................................................................10
5.3.3.2 Secondary outcomes ........................................................................10
5.3.4 Statistical consideration................................................................................10
5.3.4.1  Sample size determination...............................................................10
5.3.4.2  Analysis of endpoints......................................................................10
5.4 Ethical consideration.................................................................................................11
5.4.1 Protocole and Participation consent .............................................................11
5.4.2 Risks for patients...........................................................................................11
5.4.3 Data collecting and confidentiality ..............................................................11
6 Bibliographie..........................................................................................................................11
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1
Protocol Summary
SPONSOR
ADOREPS 
Association pour le Développement et l'Organisation de la Recherche en 
Pneumologie et sur le Sommeil
Service de Pneumologie et Réanimation Médicale 
Groupe Hospitalier Pitié-Salpêtrière 
47-83, Boulevard de l’Hôpital
75651 Paris Cedex 13
TITLE
Emotional perception and production in Facial Palsy : Respiratory, Vocal 
and Facial markers.
INVESTIGATEUR 
PRINCIPAL 
Pr Peggy Gatignol
Numbers of centers
Monocentric : Groupe Hospitalier Pitié-Salpêtrière
Study Design
Prospective study ; 
Introduction
Respiratory function, phonation and facial expressivity are related to 
emotional reaction through neurophysiological process. Specific 
emotional respiratory, vocal and facial patterns had been described in 
literature. Respiratory cycles variation is modulated by stimulus arousal. 
Furthermore, inspiratory-to-expiratory time ratio in abdominal area is 
modulated by emotional valence. Inextricably linked to respiration, vocal 
production depends on emotional arousal and valence too.
According to embodied cognition, the effector pattern of an emotion 
initiates the corresponding subjective activation. Facial recognition is 
influenced by automatic mimicry and facial feedback. To our knowledge, 
most facial feedback studies included patients with diplegia but few 
studies dealt with emotional perception in Bell’s palsy. Facial paralysis is 
a common pathology which concerns 20/100 000 inhabitants per year. 
Sudden and visible trauma, facial palsy affects voluntary and emotional 
motricity. 
The aim of the present study is to understand production and perception 
of emotion in Bell’s palsy with respiratory, vocal and facial markers. 
What impact lack of mimicry have on physiological emotional reaction in 
Bell’s palsy? To this end, prospective monocentric study will be 
conducted with 60 patients with Bell’s Palsy from grade II to grade VI of 
House & Brackmann’s scale. During production and perception of vocal 
and facial expression, respiratory rate and thoraco-abdominal movements 
will be analyzed. We hypothesize that severity of facial deficit is 
negatively correlated with variation of respiratory cycles, lower 
segmental and suprasegmental changes during vocal expression, and 
lower facial perception (congruency and arousal).
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OBJECTIVES
Main Outcome
1) Effects of facial impairment on the respiratory rate.
Secondary Outcome
2) Effects of facial impairment on pitch variation (Hz) during emotional 
vocal production. 
3) Effects of facial impairment on perception of emotional facial displays. 
Endpoints
1) Facial impairment assesed with Sunnybrook Facial Grading Scale. 
Respiratory rate is measured with chest and abdominal belt.
[Time Frame: 1hour] 
2) Acoustic measures lead with Praat Analysis software. Variation pitch 
between first and last segment of the emotional sentence calculated.
[Time Frame: 1hour] 
3) Emotional facial displays perception measured with a standardized 
emotional program in terms of congruency.
[Time Frame: 1hour] 
Inclusion Criteria
•
Patients affiliated to the health care system 
•
Patients must have been diagnosed with unilateral peripheral facial palsy 
stage III to VI, according to House and Brackmann international 
classification. 
•
To be able to read, understand and sign a consent 
•
To be able to understand French spoken and written 
Exclusion Criteria
•
Diplegia or facial graft 
•
Visual disorders, non corrected 
•
Respiratory or vocal disorders 
•
Psychiatric history 
•
Facial surgery 
Number of 
participants
60 participants.
Statistical Analysis
Mutlivariate analyses, regression analyses as well as Spearman 
correlations will be conducted. An ANOVA will be carried out with 
severity grade, facial paralyis side, sex of the patients.
Study Duration
Participation duration : 3hours
Study Duration : 20 month
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2
Introduction
2.1
Title 
Emotional perception and production in Facial Palsy : Respiratory, Vocal and Facial 
markers.
2.2
Sponsor
ADOREPS 
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur 
le Sommeil
Service de Pneumologie et Réanimation Médicale 
Groupe Hospitalier Pitié-Salpêtrière 
47-83, Boulevard de l’Hôpital
75651 Paris Cedex 13
Tel : 01 42 16 77 97 
Fax : 01 70 24 72 82
Mail : bureau@adoreps.fr
2.3
Study design 
It is a proscpective monocentric study.
2.4
Experimentation site
Service ORL et Oto-Neurochirurgie de la Pitié-Salpêtrière
47-83 Boulevard de l'Hôpital, 75013 Paris
2.5
Main Investigator
Pr Peggy Gatignol1,2
1. Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire 
Expérimentale et Clinique,  F-75005 Paris, France
2. AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service Orl et 
Otoneurochirurgie du Pr. Lamas, F-75013 Paris, France
3
Scientific Rationale
Peripheral facial palsy : facial palsy is a frequent pathology as far as it concerns 20/100 
000 inhabitant a year [1]. deficits can remain in 29% of the cases : Peitersen lists 12% of 
mild sequellae, 13% of moderate sequellae and 4% of severe sequellae. 
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Visible and sudden trauma, facial impairment is multidimensional. Indeed, it 
concerns not only the voluntary facial motricity but also the spontaneous emotional facial 
motricity through the production of universal primary facial expressions [3]. Besides, the 
facial paralysis impacts patients' quality of life thus implying psychosocial difficulties. In 
acute or chronic phase, the main complaint of the patients deal with emotional 
expressiveness, especially happiness through a large smile. Literature highlights an increase 
of anxious and depressive symptoms in patients with facial palsy [5]. Inability to express a 
smile is involved in increased depressive symptoms [6]. Lack of facial feedback would also 
explain the decreasing feeling of well-being during smile production [7]. 
Respiratory, vocal and articulatory processing are modified by cognitive, autonomous 
and somatic change during emotional contagion. According to James-Lange theory [8], 
updated by embodied cognititon [9],  somatic experiences create emotions : to be conscious of 
physical changes and generated proprioceptive feedback give rise to emotions.  On the other 
hand, six basic emotions could be distinguished in Ekman's paradigms. Each basic emotion 
implies specific autonomous, expressive and neuronal patterns : anger, disgust, fear, joy, 
sadness, surprise [10]. Two neurophysiological dimensions characterize emotion : arousal 
(activation level) and valence (pleasing aspect of a situation) [11].  
3.1
Emotions and Breathing
Breathing is modulated by arousal of a stimulus [12]. During pictures displays, an 
intense activation increases the variability of respiratory cycles [13]. According to Boiten's 
review [14], increased respiratory rate would appear in high arousal emotions. Change in 
respiratory rate would result more from arousal effect than valence. Besides, there would be 
six different respiratory patterns. Inspiratory and expiratory time ratio increase in thoracic 
level and decrease un abdominal level during highly negative emotion. Opposite pattern is 
observed for positive emotion [15]. 
According to Glaus and al., (1983) [16] and Kotses et al. (1987), airflow resistance is 
correlated to increased facial muscle tension, measured by electromyography, which suggests 
an influence of facial muscles on the air resistance through a neuronal reflex In chronic phase 
of facial palsy, it would be relevant to study respiratory capacity and facial hemispasm. 
3.2
Emotions and Vocal production 
Breathing and vocal production are indissociable ways to convey emotions. In a 
segmental framework, highly activation such as fear, anger or joy increases intensity and 
pitch whereas segment length decreases. On the contrary, sadness outputs decreased pitch and 
intensity and lengthening segment duration [18]. 
3.3
Emotions and facial expressivity
Emotional facial display perception implies an automatic neuronal activation in 
premotor cortex of the observers, the same as the one they would have conceived, if they were 
their own actors of the emotional facial expression observed [19]. Furthermore, emotion is 
processing by inconscious facial mimicry, which allow the observer to understand mental 
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state of others. Sensorimotor simulation is an other input of emotional percept construction 
[20]. 
Facial palsy affects non verbal communication by impairing emotional facial displays 
contagion [21]. Facial palsy implies cortical sensorimotor changes because of acute peripheral 
deafferentation [22]. To our knowledge, studies aboud facial mimicry and facial feedback in 
patients with facial palsy deal with diplegia [23-24]. Few studies explore emotional 
perception in unilateral peripheral facial palsy. 
Multidimensional assessment of physiological activity is required to describe somatic 
states of basic emotion. We would like to study emotion encoding and decoding in patients 
with facial palsy by focusing on respiratory and vocal markers as well as facial expressivity 
and perception.  
4
Objectives
4.1.1 Main Outcome
Effects of facial impairment on the respiratory rate.
4.1.2 Secondary Outcomes
•
Effects of facial impairment on pitch variation (Hz) during emotional vocal produc-
tion. 
•
Effects of facial impairment on perception of emotional facial displays. 
5
Study Design
5.1
Study Duration
Participation duration : 3hours
 
Study duration : 20 months
5.2
Définition de la population étudiée
Recruitement process will be carried out in the ENT department of Pitié-Salpetriere Hospital. 
5.2.1 Critères d'inclusion
•
Patients affiliated to the health care system 
•
Patients must have been diagnosed with unilateral peripheral facial palsy stage III to VI, 
according to House and Brackmann international classification. 
•
To be able to read, understand and sign a consent 
•
To be able to understand French spoken and written 
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5.2.2 Critères de non-inclusion
•
Diplegia or facial graft 
•
Visual disorders, non corrected 
•
Respiratory or vocal disorders 
•
Psychiatric history 
•
Facial surgery 
5.3
Methods
5.3.1 Schedule of activities
The schedule of activities below shows the assesments that will be accomplished at each study visit. 
(X) means assessment usually conducted in facial palsy rehabilitation and (R) means assessment 
specific for the research. 
Facial 
Rehabilitation
Research
Information and consent 
R
Inclusion and Exclusion Criteria verification
R
History of health
X
Objective assessment
Grading House & Brackman 
X
MBLF Informatisée
X
Bilabial pression (dynamomètre)
X
Photos and videos recording
X
Smile Scale
X
Subjective questionnaires
STAI questionnaire 
R
PANAS scale
R
Voice Handicap Index
R
Synkinesis Assessment Questionnaire
X
Respiratory assesments
Chest and abdominal belt
R
Spirometer
R
Vocal assesment
Acoustic measures
R
EVALAD reading
R
MEC tests
R
 
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5.3.3 Endpoints
5.3.3.1
Main outcome
1) Facial impairment assesed with Sunnybrook Facial Grading Scale. Respiratory rate is 
measured with chest and abdominal belt.
[Time Frame: 1hour] 
5.3.3.2
Secondary outcomes
2) Acoustic measures lead with Praat Analysis software. Variation pitch between first and last 
segment of the emotional sentence calculated.
[Time Frame: 1hour] 
3) Emotional facial displays perception measured with a standardized emotional program in 
terms of congruency.
[Time Frame: 1hour] 
5.3.4 Statistical consideration
5.3.4.1
 Sample size determination
There is lack of precise data in the literature on this theme, it is impossible to make a 
calculation of sample size. With the aim of an exploratory study, we would like to study at 
least 60 patients in order to be able to conduct  multivariated analysis.
5.3.4.2
 Analysis of endpoints
Respiratory data are collected with the software Labchart whereas acoustic analyses are 
conducted with Praat Software ( Boersma & Weenik, 1996). Satistical analyses will be made 
with Excel Spreadsheet and JMP.10 software. 
In order to analyse endpoints, multivariated analalyses, regression analyses will be conducted. 
Spearman and Pearson correlation will be carried out in order to determine potential 
emotional markers. ANOVA analyses would be made to show any differences among patients 
according to severity of their palsy, facial palsy side, sex or questionnaire score. 
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5.4
Ethical consideration
5.4.1 Protocole and Participation consent 
Consent forms describing in detail the study procedures and risks are given to the participant 
and written documentation of informed consent is required prior to starting study. This 
consent associated with the protocol description was already approved by ethical committee 
CPP  TOURS Region Centre Ouest 1
Board Status: Approved     Approval Number: 2018T2-09 
Board Name: Comité de Protection des Personnes 
Board Affiliation: TOURS Region Centre Ouest 1
Phone: +33247478221   Email: cpp@med.univ-tours.fr
Address: Hôpital Bretonneau 
CHRU TOURS 
Bâtiment B1 A 
2 bd Tonnelle 
37044 TOURS Cedex 9
5.4.2 Risks for patients
Evaluations (questionnaires, computerized tests) and collecting data (acoustic recordings, 
respiratory recordings) imply no significant risk, and have no residual persistent effects.Risk 
of participation
5.4.3 Data collecting and confidentiality 
The people having a direct access according to the current legal and statutory measures, in 
particular the articles L.1121-3 and R.5121-13 of the public health code (for example, the 
investigators, the people in charge of the quality control, the assistants of clinical research, 
and every collaborators in the study) take all the necessary precautions to assure the 
confidentiality of the information relative to the trials, to the people who lend themselves to it 
in particular as regards their identity as well as in the obtained results. The data collected by 
these people during the quality controls or audits are then made anonymous.
All the documents of the study will be kept for 15 years.
6
Bibliographie
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