Dysautonomia in Patients Post COVID-19 Infection

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

Detailed Description
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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.

Official Title
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Dysautonomia in Patients Post COVID-19 Infection

Conditions
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Covid19

Intervention / Treatment
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* Other: Dysautonomia


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid-19 infected patients<br>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<br>* Indicators of dysautonomia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Heart rate variability will be measured using a 2-lead ECG. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrodermal activity | Electrodermal activity will be measured by applying two skin conductance sensors. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months | 
| Respiration rate | Respiration will be measured using a respiration sensor (an elastic belt) . | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months | 
| Blood volume pulse | The blood volume pulse sensor uses fingertip photo plethysmography. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months | 
| Functionality and disability | Functional status will be evaluated by the Post-COVID-19 Functional Status Scale. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months | 
| Functionality and disability | Level of dyspnea during activities of daily living will be evaluated by the London chest Activity of Daily Living scale. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months |