Facial PalsyResPPFNCT03619720
Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers.
A study testing Records in people with Facial Palsy, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Palsy
- What is being tested?
- Records
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2018to 10 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diplegia or facial graft
- Visual disorders, non corrected
- Respiratory or vocal disorders
- Psychiatric history
- Facial surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
Paris, 75013
About this study
Official title: 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).
- Conditions
- Facial Palsy
- Being tested
- Records
- Keywords
- Emotions, Respiratory Rate, Phonation
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecordsOther
Respiratory records, Vocal records Video records Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Not described Receives: Other: Records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1hour
Secondary outcomes (2)
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.
Measured: 1hour
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).
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start11 Aug 2018
- Primary completion25 Sep 2019
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy Gatignol, Principal investigator, Laboratoire de physiopathologie respiratoire, UMR_S 1158 INSERM/UPMC " Neurophysiologie Respiratoire Expérimentale et Clinique "
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619720
- Sponsor's protocol ID
- 2018-A01043-52
- Acronym
- ResPPF
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2018
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production et Perception émotionnelle Chez Les Patients paralysés Faciaux: Marqueurs Respiratoires, Phonatoires et expressivité Faciale.
- ClinicalTrials.gov ID
- NCT03619720
- Acronym / sponsor ID
- ResPPF / 2018-A01043-52
- Conditions
- Facial Palsy
- Keywords
- Emotions, Respiratory Rate, Phonation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 11 Aug 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: Records |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Diplegia or facial graft
- Visual disorders, non corrected
- Respiratory or vocal disorders
- Psychiatric history
- Facial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RecordsRespiratory records, Vocal records Video records Questionnaires | Other | Participants |
Primary outcome
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).
2 secondary outcomes
Effects of facial impairment on pitch variation (Hz) during emotional vocal production.
Time frame: 1hour
Effects of facial impairment on perception of emotional facial displays.
Time frame: 1hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Gatignol principal investigator
Laboratoire de physiopathologie respiratoire, UMR_S 1158 INSERM/UPMC " Neurophysiologie Respiratoire Expérimentale et Clinique "
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Records in people with Facial Palsy, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of facial impairment on the respiratory rate (time frame: 1hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.