Dysautonomia in Patients Post COVID-19 Infection (DYSCO)

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

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Dysautonomia

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients who were previously infected with covid-19.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Dysautonomia; Indicators of dysautonomia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Moens Maarten

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: DYSCO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No