Dysautonomia in Patients Post COVID-19 Infection
- Conditions
- Covid19
- Interventions
- Other: Dysautonomia
- Registration Number
- NCT04716465
- Lead Sponsor
- Moens Maarten
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Covid-19 infected patients Dysautonomia 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.
- Primary Outcome Measures
Name Time Method Heart rate variability 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
Name Time Method Blood volume pulse The change between baseline, 3 months (primary time endpoint), 6 months and 12 months The blood volume pulse sensor uses fingertip photo plethysmography.
Respiration rate 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) .
Electrodermal activity 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.
Functionality and disability 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.
Trial Locations
- Locations (1)
Universitair Ziekenhuis Brussel
🇧🇪Jette, Brussel, Belgium