- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619720
Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers. (ResPPF)
Production et Perception émotionnelle Chez Les Patients paralysés Faciaux: Marqueurs Respiratoires, Phonatoires et expressivité Faciale.
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. Most facial feedback studies included patients with diplegia but few studies dealt with emotional perception in Bell's palsy.
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. The investigators 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).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75013
- Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants
|
Respiratory records, Vocal records Video records Questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of facial impairment on the respiratory rate
Time Frame: 1hour
|
Facial impairment assesed with Sunnybrook Facial Grading Scale Composite Score in %. Respiratory rate is measured with chest and abdominal belt (breaths per minute). |
1hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of facial impairment on pitch variation (Hz) during emotional vocal production.
Time Frame: 1hour
|
Acoustic measures lead with Praat Analysis software.
Variation pitch between first and last segment of the emotional sentence calculated in Herz.
|
1hour
|
Effects of facial impairment on perception of emotional facial displays.
Time Frame: 1hour
|
Emotional facial displays perception measured with a standardized emotional program in terms of congruency (total score and standard deviation).
|
1hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peggy Gatignol, Laboratoire de physiopathologie respiratoire, UMR_S 1158 INSERM/UPMC " Neurophysiologie Respiratoire Expérimentale et Clinique "
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A01043-52
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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