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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03619720
Other study ID # 2018-A01043-52
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 11, 2018
Est. completion date April 10, 2020

Study information

Verified date July 2020
Source Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 10, 2020
Est. primary completion date September 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Records
Respiratory records, Vocal records Video records Questionnaires

Locations

Country Name City State
France Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation Paris

Sponsors (1)

Lead Sponsor Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 1hour
Secondary 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). 1hour
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