Dysautonomia in Patients Post COVID-19 Infection

Covid19 Clinical Trial

— DYSCO  

Official title:

Dysautonomia in Patients Post COVID-19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716465
• Other study ID #: DYSCO
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: January 2023

Study information

• Verified date: January 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: Marc Schiltz, MD
• Phone: +32 2 477 60 20
• Email: marc.schiltz[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Covid19
• Primary Dysautonomias

Intervention

Other:
• Dysautonomia
Indicators of dysautonomia

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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