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Completed

NCT Number: NCT04363749

COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint

Other

the fraction of inspired oxygen is reduced from ~21% (room air) to 14.3 and 12.7% allowing the SpO2 to decrease to ~75%, rebreathing test allowing the PCO2 to rise to 65 mmHg, inspiratory mechanical constraint with 50 to 75% of maximum inspiratory pressure

Primary outcomes

  1. Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)

    Time frame: 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 outcomes

  1. Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2)

    Time frame: 5 minutes

    ratings of dyspnea immediately after a hypoxic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable

  2. Perception of a hypercapnic stimulus induced dyspnea (7% CO2)

    Time frame: 10 minutes

    ratings of dyspnea intensity and unpleasantness during a hypercapnic stimulus (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)

  3. Perception of a hypercapnic stimulus induced dyspnea (7% CO2)

    Time frame: 5 minutes

    ratings of dyspnea immediately after a hypercapnic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable

  4. Perception of a inspiratory mechanical constraint induced dyspnea

    Time frame: 10 min

    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)

  5. Perception of a inspiratory mechanical constraint induced dyspnea

    Time frame: 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)

  6. brain MRI

    Time frame: 1,5 hours

    Multimodal MRI (including anatomical MRI, resting-state functional MRI)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Do Respiratory Control Center Anomalies Explain the Lack of Respiratory Sensations Perceptions Observed in Patients Affected by COVID-19 ?

Acronym: CRC-COVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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