Autonomic Nervous System Affection Due to Post Covid Syndrome

NCT05502094 | Completed

• 1 other identifier: STUDYAV0002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long Covid19; Autonomic Dysfunction

Outcome Measures

Primary Outcomes (4)

• Heart Rate Variability-Time Dependent(RMSSD)

  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

  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

  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)

  High Frequency (HF)/ Low Frequency(HF/LF): Ratio of LF-to-HF power. Unit: %

  Through study completion, an average of 1 year.

Secondary Outcomes (1)

• Body mass index (BMI)

  Through study completion, an average of 1 year.

Study Arms (3)

Group 1

Participants who experienced Post-Covid 19 syndrome were involved in this group.

Other: Heart Rate Variability Measurement

Group 2

Participants who fully recovered after Covid-19 were involved in this group.

Other: Heart Rate Variability Measurement

Group 3

Participants who had never had Covid-19 were involved in this group.

Other: Heart Rate Variability Measurement

Interventions

Heart Rate Variability Measurement OTHER

The heart rate variability of the participants will be measured with the Polar H10 device with a measurement time of 5 minutes.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Participants who aged 18-45 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir University

Istanbul, Beşiktaş, 34000, Turkey (Türkiye)

Location

Related Publications (15)

• Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.

  PMID: 32784198 RESULT

• National Insitute for Health and Care Excellence; SIGN. Royal College of General Practitioners COVID-19 Guideline Scope: Management of the Long-Term Effects of COVID-19; NICE: London, UK, 2020; pp. 1-7.

  RESULT

• Cares-Marambio K, Montenegro-Jimenez Y, Torres-Castro R, Vera-Uribe R, Torralba Y, Alsina-Restoy X, Vasconcello-Castillo L, Vilaro J. Prevalence of potential respiratory symptoms in survivors of hospital admission after coronavirus disease 2019 (COVID-19): A systematic review and meta-analysis. Chron Respir Dis. 2021 Jan-Dec;18:14799731211002240. doi: 10.1177/14799731211002240.

  PMID: 33729021 RESULT

• Konig MF, Powell M, Staedtke V, Bai RY, Thomas DL, Fischer N, Huq S, Khalafallah AM, Koenecke A, Xiong R, Mensh B, Papadopoulos N, Kinzler KW, Vogelstein B, Vogelstein JT, Athey S, Zhou S, Bettegowda C. Preventing cytokine storm syndrome in COVID-19 using alpha-1 adrenergic receptor antagonists. J Clin Invest. 2020 Jul 1;130(7):3345-3347. doi: 10.1172/JCI139642. No abstract available.

  PMID: 32352407 RESULT

• Goldstein DS. The extended autonomic system, dyshomeostasis, and COVID-19. Clin Auton Res. 2020 Aug;30(4):299-315. doi: 10.1007/s10286-020-00714-0. Epub 2020 Jul 22.

  PMID: 32700055 RESULT

• Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26.

  PMID: 33243837 RESULT

• McCorry LK. Physiology of the autonomic nervous system. Am J Pharm Educ. 2007 Aug 15;71(4):78. doi: 10.5688/aj710478.

  PMID: 17786266 RESULT

• Tindle J, Tadi P. Neuroanatomy, Parasympathetic Nervous System. 2022 Oct 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553141/

  PMID: 31985934 RESULT

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 RESULT

• Barauskiene V, Rumbinaite E, Karuzas A, Martinkute E, Puodziukynas A. Importance of Heart Rate Variability in Patients with Atrial Fibrillation. J Cardiol Clin Res. 2016;4:1080.

  RESULT

• Costa JYB, Anunciaçao PG, Ruiz RJ, Casonatto J, Polito MD. Effect of Caffeine Intake on Blood Pressure and Heart Rate Variability after a Single Bout of Aerobic Exercise. International SportMed Journal 2012; 13 (3): 109-121.

  RESULT

• Hayano J, Yuda E. Pitfalls of assessment of autonomic function by heart rate variability. J Physiol Anthropol. 2019 Mar 13;38(1):3. doi: 10.1186/s40101-019-0193-2.

  PMID: 30867063 RESULT

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 RESULT

• Kleiger RE, Miller JP, Bigger JT Jr, Moss AJ. Decreased heart rate variability and its association with increased mortality after acute myocardial infarction. Am J Cardiol. 1987 Feb 1;59(4):256-62. doi: 10.1016/0002-9149(87)90795-8.

  PMID: 3812275 RESULT

• Gilgen-Ammann R, Schweizer T, Wyss T. RR interval signal quality of a heart rate monitor and an ECG Holter at rest and during exercise. Eur J Appl Physiol. 2019 Jul;119(7):1525-1532. doi: 10.1007/s00421-019-04142-5. Epub 2019 Apr 19.

  PMID: 31004219 RESULT

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Primary Dysautonomias

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Ali Veysel Özden, M.D.

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle İnvestigator

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 16, 2022
• Study Start: February 15, 2023
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)