NCT04851080

Medico-ecological Monitoring ((CSM, MCTQ, SPAQ, PSQI, HRV, Spirometry; Anthropometry, BP) of the Different Population Groups (Students, Schoolchildren, Volunteers) in North Caucasus

Study of the Chronotype, Sleep Quality, Seasonal Pattern, Behavioral Time Preferences and the Functional State of the Body's Regulatory, Respiratory Systems in Individuals of Different Metabolic Status and Age

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 370 (estimated)
• Sponsor: Vladikavkaz Scientific Center of the Russian Academy of Sciences · Network
• Sex: All
• Age: 13 Years – 57 Years
• Healthy volunteers: Accepted

Summary

Observational Clinical Trial of the chronotype, sleep quality, seasonal pattern, behavioral time preferences, the functional state of the body's regulatory systems and respiratory systems in individuals of different age groups and metabolic status. In the process of medico-ecological monitoring, including all of the above, an assessment of the psycho-physiological status and the state of the regulatory and respiratory systems of the subjects' body, living in North Ossetia-Alania, will be made.

Detailed description

Modern methods of medicine are aimed at maintaining homeostasis in a situation when, under the influence of factors of the external or internal environment, acute, chronical and extreme (in Covid-19 isolation) physiological stress, is formed, which the body is no longer able to compensate, and which forms the main group of human diseases - adaptation diseases, primarily cardiovascular, including cardiometabolic syndrome. Against the background of the Covid-19 pandemic, in conditions of limited physical activity, disruption of the daily routine and high psychophysiological load, various health disorders of both functional and organic nature may occur and existing pathologies may worsen. The aim of the study - screening of health of different age categories of the population, based on research of chronotype, sleep quality, seasonal pattern, behavioral time preferences and functional state of body's regulatory and respiratory systems in individuals from the different age groups. Methods: testing of psycho-physiological functions using Composite Scale of Morningness (CSM), Munich ChronoType Questionnaire (MCTQ), Seasonal Pattern Assessment Questionnaire (SPAQ), Pittsburgh Sleep Quality Index (PSQI); Heart rate variability (HRV); Spirometry; Anthropometry (measurement of height, weight, waist circumference), Blood pressure measurement (BP). Statistical analyses planned to perform frequency, correlation, factorial and variance analyzes using Statistica 10,0 software ("StatSoft, Inc"). Data investigate by mean value (M) and standard deviation (SD) in case of normal data distribution or nonparametric method with determination of median (Me) and interquantile ranges (25th and 75th percentile) in the case of a distribution other than normal. ANOVA, MANOVA analysis. Statistically significant differences in all statistical tests set to P\<0.05

Conditions

• Conditionally Healthy Persons
• Persons With a High Body Mass Index

Interventions

Type	Name	Description
DEVICE	Heart Rate Variability	Heart rate variability is carried out using the complex of prenosological diagnostics "VARICARD 2.51" with the ISCIM 6.2 program is methodically based on the technology of analysis of heart rate variability, it uses the original scientific and theoretical substantiation of HRV indicators, which is based on modern ideas about stress, functional state of the body and assessment of health levels. It is designed to assess the risk of developing diseases in persons who are in states bordering health and disease. A decrease in the adaptive capabilities of the organism is considered as the main risk factor, the results obtained with its help are considered from the point of view of the level of health or stressful effects. It can be successfully used to control the effectiveness of medical intervention. Functionally, the complex is designed to register an electrical signal and form conclusions about the functional state of the body, assess the level of stress and its effect on health.
DEVICE	Spirometry	Spirometry is carried out using the device Spirotest USPTs-01, equipped with liquid crystal indicators. It is non-invasive method for measuring air flows and volumes as a function of time using forced maneuvers. It is intended for functional diagnostics of the lungs, namely, indication and measurement of forced vital capacity and forced expiratory volume in the first second.
BEHAVIORAL	Testing of psycho-physiological functions using four questionnaires	Research of the behavioral time preferences by Composite Scale of Morningness (CSM, Smith C.S., Reilly C., Midkiff K., 1989). Translation into Russian by Kolomeichuk S., May 2015), of the chronotype by Munich ChronoType Questionnaire (MCTQ, Roenneberg T., Merrow M., LMU München, 2006, 2008. Translation into Russian by Putilov A.A., Danilenko K.V., approved by the authors October 2007, updated 2010), of the seasonal pattern by Seasonal Pattern Assessment Questionnaire (SPAQ, Rosenthal N.E., Genhart M., Sack D.A., Skwerer R.G., Wehr T.A., 1987.Translation into Russian by Putilov A.A., Danilenko K.V., Korneeva N.I. 1988, 2002), of the sleep quality by Pittsburgh Sleep Quality Index (PSQI, Russian edition Semenova E.A., Danilenko K.V., October 2009)

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-05-01
• Completion: 2021-12-01
• First posted: 2021-04-20
• Last updated: 2021-04-20

Locations

1 site across 1 country: Russia