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Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers. (ResPPF)

Primary Purpose

Facial Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Records
Sponsored by
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Facial Palsy focused on measuring Emotions, Respiratory Rate, Phonation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

Outcomes

Primary Outcome Measures

Effects of facial impairment on the respiratory rate
Facial impairment assesed with Sunnybrook Facial Grading Scale Composite Score in %. Respiratory rate is measured with chest and abdominal belt (breaths per minute).

Secondary Outcome Measures

Effects of facial impairment on pitch variation (Hz) during emotional vocal production.
Acoustic measures lead with Praat Analysis software. Variation pitch between first and last segment of the emotional sentence calculated in Herz.
Effects of facial impairment on perception of emotional facial displays.
Emotional facial displays perception measured with a standardized emotional program in terms of congruency (total score and standard deviation).

Full Information

First Posted
July 21, 2018
Last Updated
August 13, 2020
Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
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1. Study Identification

Unique Protocol Identification Number
NCT03619720
Brief Title
Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers.
Acronym
ResPPF
Official Title
Production et Perception émotionnelle Chez Les Patients paralysés Faciaux: Marqueurs Respiratoires, Phonatoires et expressivité Faciale.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 11, 2018 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
April 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Palsy
Keywords
Emotions, Respiratory Rate, Phonation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Records
Intervention Description
Respiratory records, Vocal records Video records Questionnaires
Primary Outcome Measure Information:
Title
Effects of facial impairment on the respiratory rate
Description
Facial impairment assesed with Sunnybrook Facial Grading Scale Composite Score in %. Respiratory rate is measured with chest and abdominal belt (breaths per minute).
Time Frame
1hour
Secondary Outcome Measure Information:
Title
Effects of facial impairment on pitch variation (Hz) during emotional vocal production.
Description
Acoustic measures lead with Praat Analysis software. Variation pitch between first and last segment of the emotional sentence calculated in Herz.
Time Frame
1hour
Title
Effects of facial impairment on perception of emotional facial displays.
Description
Emotional facial displays perception measured with a standardized emotional program in terms of congruency (total score and standard deviation).
Time Frame
1hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy Gatignol
Organizational Affiliation
Laboratoire de physiopathologie respiratoire, UMR_S 1158 INSERM/UPMC " Neurophysiologie Respiratoire Expérimentale et Clinique "
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Learn more about this trial

Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers.

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