NCT04363749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

April 20, 2020

Last Update Submit

August 27, 2021

Conditions

Covid19Neurological Complication

Keywords

SARS-CoV-2COVID-19dyspneahypoxic stimulus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    5 minutes

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

    10 minutes

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

    5 minutes

  • Perception of a inspiratory mechanical constraint induced dyspnea

    10 min

  • Perception of a inspiratory mechanical constraint induced dyspnea

    5 minutes

  • +1 more secondary outcomes

Study Arms (2)

15 COVID positive patients

EXPERIMENTAL

dyspnea rating to various dyspneic stimulus

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

15 healthy controls

ACTIVE COMPARATOR

dyspnea rating to various dyspneic stimulus

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

Interventions

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

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

15 COVID positive patients15 healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département R3S, hôpital de la pitié-salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

COVID-19Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 27, 2020

Study Start

April 27, 2020

Primary Completion

January 11, 2021

Study Completion

January 11, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)