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Dysautonomia in Patients Post COVID-19 Infection

Dysautonomia in Patients Post COVID-19 Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04716465
Acronym
DYSCO
Enrollment
200
Registered
2021-01-20
Start date
2021-01-19
Completion date
2023-01-31
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

OTHERDysautonomia

Indicators of dysautonomia

Sponsors

Moens Maarten
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variabilityThe change between baseline, 3 months (primary time endpoint), 6 months and 12 monthsHeart rate variability will be measured using a 2-lead ECG.

Secondary

MeasureTime frameDescription
Electrodermal activityThe change between baseline, 3 months (primary time endpoint), 6 months and 12 monthsElectrodermal activity will be measured by applying two skin conductance sensors.
Respiration rateThe change between baseline, 3 months (primary time endpoint), 6 months and 12 monthsRespiration will be measured using a respiration sensor (an elastic belt) .
Blood volume pulseThe change between baseline, 3 months (primary time endpoint), 6 months and 12 monthsThe blood volume pulse sensor uses fingertip photo plethysmography.
Functionality and disabilityThe change between baseline, 3 months (primary time endpoint), 6 months and 12 monthsFunctional status will be evaluated by the Post-COVID-19 Functional Status Scale.

Countries

Belgium

Contacts

Primary ContactMarc Schiltz, MD
marc.schiltz@uzbrussel.be+32 2 477 60 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026