Covid19 Clinical Trial
— CRC-COVIDOfficial title:
Do Respiratory Control Center Anomalies Explain the Lack of Respiratory Sensations Perceptions Observed in Patients Affected by COVID-19 ?
Verified date | August 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the present study is to determine whether there is a decrease in the emotional response to experimental induction of dyspnea by hypoxic stimulation in subjects with a "neurological" form of COVID-19, compared to healthy controls.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 11, 2021 |
Est. primary completion date | January 11, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - - adult (= 18 years old, unprotected); - for COVID-19 + patients: COVID-19 + diagnosis; with quantitative or qualitative anomalies in taste and smell; first symptoms appeared in less than 21 days - for healthy subjects: have never presented any sign of COVID ; confirmed by recent negative serology - understanding French; - affiliated to social security; - having a BMI between 20 and 30; - preferably non-smokers and in the event of recruitment difficulties, smokers but with smoking <5 packs - year - signature of the informed consent form Exclusion Criteria: - respiratory signs or symptoms (rhinitis, cough, shortness of breath at rest); - temperature above 37.5 ° C; - existence of a chronic respiratory pathology (including asthma and COPD in the first row); - pregnant women ; - protected minors and adults, persons deprived of their liberty; - not affiliated to a social security (including AME); - contraindication to MRI (pace maker, intracranial implants, etc.). |
Country | Name | City | State |
---|---|---|---|
France | Département R3S, hôpital de la pitié-salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2) | Slope of the relation between the intensity of a hypoxic stimulus to the intensity of the emotional response (visual analog scale, VAS : 0 is no pain and 10 is the worst pain) | 10 minutes | |
Secondary | Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2) | ratings of dyspnea immediately after a hypoxic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable | 5 minutes | |
Secondary | Perception of a hypercapnic stimulus induced dyspnea (7% CO2) | ratings of dyspnea intensity and unpleasantness during a hypercapnic stimulus (visual analog scale, VAS : 0 is no pain and 10 is the worst pain) | 10 minutes | |
Secondary | Perception of a hypercapnic stimulus induced dyspnea (7% CO2) | ratings of dyspnea immediately after a hypercapnic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable | 5 minutes | |
Secondary | Perception of a inspiratory mechanical constraint induced dyspnea | ratings of dyspnea intensity and unpleasantness during an inspiratory mechanical constraint (visual analog scale, VAS: 0 is no pain and 10 is the worst pain) | 10 min | |
Secondary | Perception of a inspiratory mechanical constraint induced dyspnea | ratings of dyspnea immediately after an inspiratory mechanical constraint induced dyspnea(Multidisciplinary Dyspnea Profile, MDP: 0 is no change and 10 is unbearable) | 5 minutes | |
Secondary | brain MRI | Multimodal MRI (including anatomical MRI, resting-state functional MRI) | 1,5 hours |
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