Clinical trial NCT04363749: COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities
Official title: Do Respiratory Control Center Anomalies Explain the Lack of Respiratory Sensations Perceptions Observed in Patients Affected by COVID-19 ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Neurological Complication
Keywords: SARS-CoV-2
COVID-19
dyspnea
hypoxic stimulus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: SARS CoV-2 infection causes lung damage that can be severe enough to require artificial ventilation. Clinicians taking care of these patients are surprised by the scant respiratory sensations and emotional responses described by patients. This attenuation of respiratory interoception deprives clinicians of the usual warning signs during respiratory decompensation of dyspnea and its aggravation. It may be the result of central nerve damage. This hypothesis is bolstered by the observation that within the multiple clinical forms of COVID-19 infection there are some "neurological" forms (headache, anosmia, agueusia, dizziness, without respiratory signs and with little or no fever), that are most likely the consequence of olfactory penetration of the virus into the central nervous system (mechanism described for SARS CoV-1).

Eligibility criteria: 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.).

Primary outcomes:
measure: Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)
timeFrame: 10 minutes
Secondary outcomes:
measure: Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2)
timeFrame: 5 minutes
measure: Perception of a hypercapnic stimulus induced dyspnea (7% CO2)
timeFrame: 10 minutes
measure: Perception of a hypercapnic stimulus induced dyspnea (7% CO2)
timeFrame: 5 minutes
measure: Perception of a inspiratory mechanical constraint induced dyspnea
timeFrame: 10 min
measure: Perception of a inspiratory mechanical constraint induced dyspnea
timeFrame: 5 minutes
measure: brain MRI
timeFrame: 1,5 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Département R3S, hôpital de la pitié-salpêtrière
Study officials:
References: