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Dysautonomia in Patients Post COVID-19 Infection (DYSCO)

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ClinicalTrials.gov Identifier: NCT04716465
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Moens Maarten, Universitair Ziekenhuis Brussel

Brief Summary:
The aim for this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.

Condition or disease Intervention/treatment
Covid19 Other: Dysautonomia

Detailed Description:

The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.

Potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms in patients recovered from COVID-19 infection are frequently a complaint with at least 1 symptom, particularly fatigue and dyspnea. In recent papers, the authors commented on the potential role of dysautonomia in the post-covid-19 entity related to microangiopathy and endothelial injury. Such lesions were already reported in brain biopsy samples of severe COVID-19.

Therefore, the aim of this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dysautonomia in Patients Post COVID-19 Infection
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Covid-19 infected patients
In this study male and female patients who were previously infected with covid-19 (symptomatic and asymptomatic) will be included. Patients will only be eligible if they had a positive covid-19 test before inclusion in the study. More specifically, only patients who had a positive COVID-19 test 2 to 8 weeks before study inclusion are eligible.
Other: Dysautonomia
Indicators of dysautonomia




Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: The change between baseline, 3 months (primary time endpoint), 6 months and 12 months ]
    Heart rate variability will be measured using a 2-lead ECG.


Secondary Outcome Measures :
  1. Electrodermal activity [ Time Frame: The change between baseline, 3 months (primary time endpoint), 6 months and 12 months ]
    Electrodermal activity will be measured by applying two skin conductance sensors.

  2. Respiration rate [ Time Frame: The change between baseline, 3 months (primary time endpoint), 6 months and 12 months ]
    Respiration will be measured using a respiration sensor (an elastic belt) .

  3. Blood volume pulse [ Time Frame: The change between baseline, 3 months (primary time endpoint), 6 months and 12 months ]
    The blood volume pulse sensor uses fingertip photo plethysmography.

  4. Functionality and disability [ Time Frame: The change between baseline, 3 months (primary time endpoint), 6 months and 12 months ]
    Functional status will be evaluated by the Post-COVID-19 Functional Status Scale.

  5. Functionality and disability [ Time Frame: The change between baseline, 3 months (primary time endpoint), 6 months and 12 months ]
    Level of dyspnea during activities of daily living will be evaluated by the London chest Activity of Daily Living scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients who were previously infected with covid-19.
Criteria

Inclusion Criteria:

  • Patients with a diagnosed covid-19 infection that took place 2-8 weeks before study inclusion.
  • Cognitive and language functioning enabling coherent communication between the researcher and the participant.
  • French-or Dutch speaking persons.

Exclusion Criteria:

  • Covid-19 infection > 8 weeks ago.
  • The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716465


Contacts
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Contact: Marc Schiltz, MD +32 2 477 60 20 marc.schiltz@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Jette, Brussel, Belgium, 1090
Contact: Marc Schiltz, MD    +32 2 477 60 20    marc.schiltz@uzbrussel.be   
Principal Investigator: Marc Schiltz         
Sub-Investigator: Ann De Smedt         
Sub-Investigator: Samar Hatem         
Sub-Investigator: Maarten Moens         
Sub-Investigator: Lisa Goudman         
Sponsors and Collaborators
Moens Maarten
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Responsible Party: Moens Maarten, investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04716465    
Other Study ID Numbers: DYSCO
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases