COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities

Not Applicable

Completed

• Conditions: Covid19; Neurological Complication

• Registration Number: NCT04363749
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-24
• Study Start: 2020-04-27
• Study First Posted: 2020-04-27
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)	10 minutes	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)

Secondary Outcome Measures

Name	Time	Method
Perception of a hypercapnic stimulus induced dyspnea (7% CO2)	5 minutes	ratings of dyspnea immediately after a hypercapnic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
brain MRI	1,5 hours	Multimodal MRI (including anatomical MRI, resting-state functional MRI)
Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2)	5 minutes	ratings of dyspnea immediately after a hypoxic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
Perception of a inspiratory mechanical constraint induced dyspnea	5 minutes	ratings of dyspnea immediately after an inspiratory mechanical constraint induced dyspnea(Multidisciplinary Dyspnea Profile, MDP: 0 is no change and 10 is unbearable)

Trial Locations

Locations (1)

Département R3S, hôpital de la pitié-salpêtrière; 🇫🇷 Paris, France