Dysautonomia in Patients Post COVID-19 Infection

NCT04716465 | Unknown

• 1 other identifier: DYSCO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Electrodermal activity

  The change between baseline, 3 months (primary time endpoint), 6 months and 12 months

• Respiration rate

  The change between baseline, 3 months (primary time endpoint), 6 months and 12 months

• Blood volume pulse

  The change between baseline, 3 months (primary time endpoint), 6 months and 12 months

• Functionality and disability

  The change between baseline, 3 months (primary time endpoint), 6 months and 12 months

• Functionality and disability

  The change between baseline, 3 months (primary time endpoint), 6 months and 12 months

Study Arms (1)

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

Interventions

Dysautonomia OTHER

Indicators of dysautonomia

Covid-19 infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Cognitive and language functioning enabling coherent communication between the researcher and the participant.
• French-or Dutch speaking persons.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Moens Maarten: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marc Schiltz, MD

CONTACT

+32 2 477 60 20; marc.schiltz@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 20, 2021
• Study Start: January 19, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

BE (1)