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
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
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.
Indicators of dysautonomia
- 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.
- 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.
- 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) .
- 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.
- 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.
- 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.
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
|Contact: Marc Schiltz, MD||+32 2 477 60 firstname.lastname@example.org|
|Universitair Ziekenhuis Brussel||Recruiting|
|Jette, Brussel, Belgium, 1090|
|Contact: Marc Schiltz, MD +32 2 477 60 20 email@example.com|
|Principal Investigator: Marc Schiltz|
|Sub-Investigator: Ann De Smedt|
|Sub-Investigator: Samar Hatem|
|Sub-Investigator: Maarten Moens|
|Sub-Investigator: Lisa Goudman|