Autonomic Nervous System Affection Due to Post Covid Syndrome

March 20, 2023 updated by: Alper Percin, Bahçeşehir University

Identification of the Effects of Post Covid Syndrome on the Autonomic Nervous System With Heart Rate Variability

Post-Covid syndrome is defined as symptoms that develop in addition to respiratory symptoms in individuals who have had Covid-19 infection for more than 12 weeks. Symptoms such as fatigue, headache, cognitive impairment, dyspnea, heart palpitations, heat intolerance, digestive system disorders, sleep disorders, dermal problems, orthostatic intolerance come to the fore in individuals with post-Covid syndrome. It has been tried to be revealed in some studies that Covid-19 infection affects the autonomic nervous system (ANS) and the relationship between Post-Covid 19 syndrome and ANS dysfunction. Heart rate variability (HRV) measurement method can be used to evaluate ANS activity. HRV is a non-invasive method and is a measure of the change in heart rate over a period of time. HRV is a scalar quantity that shows the time between two beats of the heart and defines the oscillations between the R-R intervals. In HRV measurements, time-dependent and frequency-dependent measurement results are obtained and from these measurements, time-dependent RMSSD (square root of the square of the difference of the R-R intervals) and frequency-dependent high-frequency (HF) and low frequency (LF) measurement components are used in relation to the sympathetic nervous system (CNS) and parasympathetic nervous system (PSS). HRV can be measured in short-term (5 minutes) in terms of measurement time. The aim of this study is to clearly reveal the relationship between Post-Covid 19 syndrome and ANS dysfunction and to provide standardization related to HRV measurement method and sub-parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SARS-CoV-2 virus emerged with severe acute respiratory tract infection and pneumonia when turned into a chronic disease that can cause permanent symptoms in recovering individuals. Prolonged Covid-19 syndrome or Post-Covid 19 syndrome is defined as symptoms that develop in addition to respiratory symptoms in individuals who have had Covid-19 infection for more than 12 weeks. Symptoms such as fatigue, headache, cognitive impairment, dyspnea, heart palpitations, heat intolerance, digestive system disorders, sleep disorders, dermal problems, orthostatic intolerance come to the fore in individuals with post-Covid syndrome. It has been tried to be revealed in some studies that Covid-19 infection affects the autonomic nervous system (ANS) and the relationship between Post-Covid 19 syndrome and ANS dysfunction. It is known that the cytokine storm caused by Covid-19 is caused by sympathetic activation that induces the release of proinflammatory cytokines, and the virus is associated with autoantibodies such as α(alpha) and β(beta) adrenoceptors and muscarinic receptors and in this case it causes autoimmunological disorder and ANS dysfunction. ANS consists of craniosacral parasympathetic fibers and cervicothoracic sympathetic fibers and consists of a complex network structure that provides homeostasis of the body. The parasympathetic nervous system predominates in quiet "rest and digest" conditions, while the sympathetic nervous system drives the "fight or flight" response in stressful situations. Heart rate variability (HRV) measurement method can be used to evaluate ANS activity. HRV is a non-invasive method and is a measure of the change in heart rate over a period of time. HRV is a scalar quantity that shows the time between two beats of the heart and defines the oscillations between the R-R intervals. In HRV measurements, time-dependent and frequency-dependent measurement results are obtained and from these measurements, time-dependent RMSSD (square root of the square of the difference of the R-R intervals) and pNN50 (the proportionality coefficient obtained by dividing the total number of R-R intervals by NN50), frequency-dependent high-frequency (HF) and low frequency (LF) measurement components are used in relation to the sympathetic nervous system (CNS) and parasympathetic nervous system (PSS). HRV can be measured in 3 different ways, as ultra short-term (<5 minutes), short-term (5 minutes) and long-term (24 hours), in terms of measurement time, and these values provide different results from each other. While 24-hour long-term measurements are preferred in cardiac diseases with a risk of mortality, short-term and ultra short-term measurements may be preferred in measuring the effect of chronic and metabolic diseases on HRV. The aim of this study is to clearly reveal the relationship between Post-Covid 19 syndrome and ANS dysfunction and to provide standardization related to HRV measurement method and sub-parameters.

Our study in which investigated the effect of post-Covid 19 syndrome on the autonomic nervous system, will be carried out in the Bahçeşehir University Institute of Health Sciences. Written consent will be obtained from the participants, indicating that they agreed to participate in the study and the content of the study was presented verbally and in writing form. Patients will be taken a short 5-minute measurement for HRV measurement once during the study. Before the evaluation, sociodemographic information will be obtained from the participants in the form of a questionnaire and the symptoms experienced by the participants were recorded. Participants will be warned not to exert excessive effort and not to take any medication or treatment before the measurement. In the research form given to the patients, the symptoms of individuals with Post-Covid 19 syndrome will be marked and the percentage of these symptoms was calculated. These symptoms will be determined as fatigue, headache, cognitive impairment, dyspnea, heart palpitation, heat intolerance, digestive system disorders, sleep disturbance, dermal problems, orthostatic intolerance.

A total of 60 participants whom between the ages of 18-45 will include in our study, including 20 participants (n=20) who experience Post-Covid 19 syndrome, participants who fully recover after Covid-19 (n=20) and participants who has never have Covid-19 (n=20). In order for the study groups to be homogeneous, the ratio of the number of men and women in the groups will tried to be equal.

The Polar H10 wearable HRV measurement technology, which we use in our study and produced by Polar Electro company, is a device that helps to measure the R-R interval at rest and at different activity intensities (Picture 1). In the study conducted by Schweizer et al., it shows that the Polar H10 device had 99.6% R-R interval signal quality during 5 different activities (16).

In our research, the measurements will made with the Polar H10 device were analyzed on the computer with the Kubios Software 3.5.0 program (https://www.kubios.com). With this program, it is possible to apply time dependent, frequency dependent and nonlinear analysis method.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Beşiktaş
      • Istanbul, Beşiktaş, Turkey, 34000
        • Bahçeşehir University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

It consists of participants who have not had Covid 19 and who have and did not show prolonged symptoms afterward.

Description

Inclusion Criteria:

  • Participants who aged 18-45 years

Exclusion Criteria:

  • Considering that the estrogen level in the body affects ANS among female patients, female participants in pre-menopausal, post-menopausal and pregnancy conditions
  • Being in the date of women in the menstruation period
  • Cancer diagnosis and treatment,
  • Neurological disease diagnosis,
  • Immunological disease diagnosis,
  • History of cardiovascular disease diagnosis
  • Presence of acute infection
  • Participants who used medication in the last 6 months for the treatment of ANS dysfunction were also excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Participants who experienced Post-Covid 19 syndrome were involved in this group.
Other: Heart Rate Variability Measurement
The heart rate variability of the participants will be measured with the Polar H10 device with a measurement time of 5 minutes.
Group 2
Participants who fully recovered after Covid-19 were involved in this group.
Other: Heart Rate Variability Measurement
The heart rate variability of the participants will be measured with the Polar H10 device with a measurement time of 5 minutes.
Group 3
Participants who had never had Covid-19 were involved in this group.
Other: Heart Rate Variability Measurement
The heart rate variability of the participants will be measured with the Polar H10 device with a measurement time of 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability-Time Dependent(RMSSD)
Time Frame: Through study completion, an average of 1 year.
RMSSD: Root mean square of successive RR interval differences. Unit: miliseconds(ms)
Through study completion, an average of 1 year.
Heart Rate Variability-Frequency Dependent- Low Frequency (LF) Power
Time Frame: Through study completion, an average of 1 year.
Low Frequency Power (LF): Relative power of the low-frequency band (0.04-0.15 Hz) in normal units. Unit: nu
Through study completion, an average of 1 year.
Heart Rate Variability-Frequency Dependent- High Frequency (HF) Power
Time Frame: Through study completion, an average of 1 year.
High Frequency (HF) Power: Relative power of the high-frequency band (0.15-0.4 Hz) in normal units. Unit:nu
Through study completion, an average of 1 year.
Heart Rate Variability-Frequency Dependent- High Frequency (HF)/ Low Frequency(HF/LF)
Time Frame: Through study completion, an average of 1 year.
High Frequency (HF)/ Low Frequency(HF/LF): Ratio of LF-to-HF power. Unit: %
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: Through study completion, an average of 1 year.
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Investigators

  • Study Director: Ali Veysel Özden, M.D., Bahçeşehir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

March 5, 2023

Study Completion (Actual)

March 5, 2023

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 13, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDYAV0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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