NCT03619720

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 11, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
Last Updated

August 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 21, 2018

Last Update Submit

August 13, 2020

Conditions

Keywords

Emotions, Respiratory Rate, Phonation

Outcome Measures

Primary Outcomes (1)

  • 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).

    1hour

Secondary Outcomes (2)

  • Effects of facial impairment on pitch variation (Hz) during emotional vocal production.

    1hour

  • Effects of facial impairment on perception of emotional facial displays.

    1hour

Study Arms (1)

Participants

EXPERIMENTAL
Other: Records

Interventions

RecordsOTHER

Respiratory records, Vocal records Video records Questionnaires

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diplegia or facial graft
  • Visual disorders, non corrected
  • Respiratory or vocal disorders
  • Psychiatric history
  • Facial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation

Paris, 75013, France

Location

MeSH Terms

Conditions

Facial Paralysis

Interventions

Records

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Peggy Gatignol

    Laboratoire de physiopathologie respiratoire, UMR_S 1158 INSERM/UPMC " Neurophysiologie Respiratoire Expérimentale et Clinique "

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2018

First Posted

August 8, 2018

Study Start

August 11, 2018

Primary Completion

September 25, 2019

Study Completion

April 10, 2020

Last Updated

August 14, 2020

Record last verified: 2020-07

Locations