Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-03-06 @ 10:39 AM
Study NCT ID:
NCT03619720
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2018-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005158', 'term': 'Facial Paralysis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011996', 'term': 'Records'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-06', 'size': 1815191, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-02T01:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2018-07-21', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of facial impairment on the respiratory rate', 'timeFrame': '1hour', 'description': 'Facial impairment assesed with Sunnybrook Facial Grading Scale Composite Score in %.\n\nRespiratory rate is measured with chest and abdominal belt (breaths per minute).'}], 'secondaryOutcomes': [{'measure': 'Effects of facial impairment on pitch variation (Hz) during emotional vocal production.', 'timeFrame': '1hour', 'description': 'Acoustic measures lead with Praat Analysis software. Variation pitch between first and last segment of the emotional sentence calculated in Herz.'}, {'measure': 'Effects of facial impairment on perception of emotional facial displays.', 'timeFrame': '1hour', 'description': 'Emotional facial displays perception measured with a standardized emotional program in terms of congruency (total score and standard deviation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emotions, Respiratory Rate, Phonation'], 'conditions': ['Facial Palsy']}, 'descriptionModule': {'briefSummary': "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.\n\nAccording 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.\n\nThe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients affiliated to the health care system\n* Patients must have been diagnosed with unilateral peripheral facial palsy stage III to VI, according to House and Brackmann international classification.\n* To be able to read, understand and sign a consent\n* To be able to understand French spoken and written\n\nExclusion Criteria:\n\n* Diplegia or facial graft\n* Visual disorders, non corrected\n* Respiratory or vocal disorders\n* Psychiatric history\n* Facial surgery'}, 'identificationModule': {'nctId': 'NCT03619720', 'acronym': 'ResPPF', 'briefTitle': 'Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers.', 'organization': {'class': 'OTHER', 'fullName': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil"}, 'officialTitle': 'Production et Perception émotionnelle Chez Les Patients paralysés Faciaux: Marqueurs Respiratoires, Phonatoires et expressivité Faciale.', 'orgStudyIdInfo': {'id': '2018-A01043-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'interventionNames': ['Other: Records']}], 'interventions': [{'name': 'Records', 'type': 'OTHER', 'description': 'Respiratory records, Vocal records Video records Questionnaires', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Peggy Gatignol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratoire de physiopathologie respiratoire, UMR_S 1158 INSERM/UPMC " Neurophysiologie Respiratoire Expérimentale et Clinique "'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}