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

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.

Study Overview

• Status: Recruiting
• Conditions: Conditionally Healthy Persons; Persons With a High Body Mass Index
• Intervention / Treatment: Device: Heart Rate Variability; Device: Spirometry; Behavioral: Testing of psycho-physiological functions using four questionnaires

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

• Study Type: Observational
• Enrollment (Anticipated): 370

Contacts and Locations

• Study Contact: Name: Larisa Ruslanovna Datieva, PhD; Phone Number: 7(672)539629; Email: institutbmi@mail.ru
• Study Contact Backup: Name: Victoria Alexandro Belyayeva, PhD; Phone Number: 9064944493; Email: pursh@inbox.ru

Study Locations

• Russian Federation
  • RNO-Alania
    • Vladikavkaz, RNO-Alania, Russian Federation, 362025
      • Recruiting
      • Institute of Biomedical Investigations - the Affilliate of Vladikavkaz Scientific Centre of the Russian Academy of Sciences
      • Contact: Larisa Ruslanovna Datieva, PhD; Phone Number: +7(672)539629; Email: institutbmi@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 57 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

population of the North Caucasus

Description

Inclusion Criteria:

conditionally healthy persons, persons with metabolic disorders in the presence of basic criterion MS - abdominal obesity.

Exclusion Criteria:

chronic somatic diseases; infectious diseases; malignant neoplasms of various organs and systems; viral infections; autoimmune diseases; mental illness; pregnancy and lactation in women

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Schoolchildren; Schoolchildren of Vladikavkaz secondary schools aged 13-16 years	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)
Students; Students of North-Ossetian State Medical Academy at the age of 19-22 years	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)
Volunteers; Scientists of the North Caucasian Research Institute of Mountain and Foothill Agriculture at the age of 30-56 years	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H, (kg)	height	5 minutes
W, (m)	weight	5 minutes
WC (cm)	waist circumference	5 minutes
HR (beats per minute) - frequency of the pulse	average pulse rate over the observation period, which integrally characterizes the level of functioning of the circulatory system.	5 minutes
SDNN, (ms) - standard deviation of all NN intervals	reflects all the cyclic components responsible for variability and the total effect of autonomic regulation of blood circulation	5 minutes
RMSSD, (ms) - square root of the mean of the sum of the squares of differences between adjacent NN intervals	measurements of short-term variation, estimate high frequency variations in heart rate and activity of the parasympathetic link of regulation.	5 minutes
pNN50, (ms)	the proportion derived by dividing NN50 by the total number of NN intervals, where NN50 - number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording	5 minutes
LF, (ms2) - power in low frequency range (0.04-0.15 Hz)	reflects the state of the sympathetic from the case of the ANS, and, in part, the parasympathetic department	5 minutes
HF, (ms2) - power in high frequency range (0.15-0.4 Hz)	reflects the parasympathetic link of regulation	5 minutes
LF/HF - ratio LF (ms2)/HF (ms2)	reflects the ratio of the levels of activity of the central and autonomous circuits of regulation	5 minutes
TP, (ms2) - total power of the heart rate variability spectrum	reflects the total power of the heart rate variability spectrum	5 minutes
FVCL, (liter) - forced vital capacity of lungs	qualifies the maximum volume of air that a person can exhale after taking the deepest possible breath	individually (at least six seconds)
FEV1, (liters per second) - forced expiratory volume in the first second of the forced expiratory maneuver	is an indicator of the mechanical properties of the ventilation apparatus, reflecting the total patency of the airways, elastic properties of the lungs and chest	1 second
mun-wd-fas (hours:minutes) - falling asleep time on working days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
mun-wd (hours:minutes) - sleep duration on working days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
mun-wd-mid (hours:minutes) - middle of sleep duration on working days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
mun-wd-wut (hours:minutes) - wake up time on working days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
mun-fd-fas (hours:minutes) - falling asleep time on weekend days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
mun-fd (hours:minutes) - sleep duration on weekend days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
mun-fd-mid (hours:minutes) - middle of sleep duration on weekend days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
mun-fd-wut (hours:minutes) - wake up time on weekend days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
DEW (hours:minutes) - daylight exposure on working days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
DEF (hours:minutes) - daylight exposure on weekend days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
JLW (hours:minutes) - jet lag on working days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
JLF (hours:minutes) - jet lag on weekend days	Parameters of Munich ChronoType Questionnaire (MCQT) (primary outcome measures 15-25) documenting individual sleep time, self-assessment of illumination and self-assessment of chronotype, taking into account work and days off separately. Sleep time is a good indicator for chronotype when adjusted for the amount of sleep received during the workweek and on weekends, as well as the amount of time subjects spend outdoors in daylight.	about 10-15 minutes on each Questionnaire
C1 (score) - Component of Pittsburgh Sleep Quality Index	"Daytime mood": how much (score) of a problem has it been to keep up enthusiasm to get things done during the past month	about 10-15 minutes on each Questionnaire
C2 (score) - Component of Pittsburgh Sleep Quality Index	"Sleep latency": minutes to fall asleep each night (≤15min=0; 16-30 min=1; 31-60 min=2, >60 min=3) + how often a person cannot fall asleep within 30 minutes (if sum is equal 0=0; 1-2=1; 3-4=2; 5-6=3)	about 10-15 minutes on each Questionnaire
C3 (score) - Component of Pittsburgh Sleep Quality Index	"Sleep duration": hours of actual sleep at night (>7=0; 6-7=1; 5-6=2; <5=3)	about 10-15 minutes on each Questionnaire
C4 (score) - Component of Pittsburgh Sleep Quality Index	"Sleep efficiency": (total of hours asleep)/(total of hours in bed) x 100; >85%=0, 75%-84%=1, 65%-74%=2, <65%=3	about 10-15 minutes on each Questionnaire
C5 (score) - Component of Pittsburgh Sleep Quality Index	"Sleep disturbance": sum of Component 5b-5j scores (0=0; 1-9=1; 10-18=2; 19-27=3)	about 10-15 minutes on each Questionnaire
C6 (score) - Component of Pittsburgh Sleep Quality Index	"Subjective sleep quality": self-reported sleep quality over the past month	about 10-15 minutes on each Questionnaire
C7(score) - Component of Pittsburgh Sleep Quality Index	"Sleeping pills and daytime sleepiness": how often a person take medicine to help asleep during the past month+ how often a person had trouble staying awake while driving, eating meals, or engaging in social activity during the past month	about 10-15 minutes on each Questionnaire
Global PSQI Score = C1+C2+C3+C4+C5+C6+C7	Each component is scored from 0 to 3 points, forming an overall PSQI score ranging from 0 to 21, where higher scores indicate poorer sleep quality. PSQI is useful for determining good and bad sleep quality. An overall PSQI score above 5 indicates poor sleep.	about 10-15 minutes on each Questionnaire
CMQ (score) - Component of Composite Scale of Morningness	Composite Scale of Morningness characterize in the form of questions: morning activity, morning affects and eveningness. CSM ask mostly for preferred time of day and imply answers based on clock times or comparisons with others in a given population. In CSM regarding preferred sleeping and waking times, respondents select the most suitable option from a list of time increments. Issues like ease of waking, alertness throughout the day, and exercise are also queried. Potential scores for the scale's items range from 1 to 4 or 5, with higher scores indicating a greater degree of morningness. Cutoffs for the scale were chosen using the upper and lower percentiles of the scale: A score of 22 or below indicates an evening type, a score above 44 indicates a morning type, and scores in between receive a classification of intermediate. In total we used two parameters: CMQ - sum of the scores of the scale's items range; CSMN - nominal chronotype rating.	about 10-15 minutes on each Questionnaire
CSMN (nominal) - Component of Composite Scale of Morningness	Composite Scale of Morningness characterize in the form of questions: morning activity, morning affects and eveningness. CSM ask mostly for preferred time of day and imply answers based on clock times or comparisons with others in a given population. In CSM regarding preferred sleeping and waking times, respondents select the most suitable option from a list of time increments. Issues like ease of waking, alertness throughout the day, and exercise are also queried. Potential scores for the scale's items range from 1 to 4 or 5, with higher scores indicating a greater degree of morningness. Cutoffs for the scale were chosen using the upper and lower percentiles of the scale: A score of 22 or below indicates an evening type, a score above 44 indicates a morning type, and scores in between receive a classification of intermediate. In total we used two parameters: CMQ - sum of the scores of the scale's items range; CSMN - nominal chronotype rating.	about 10-15 minutes on each Questionnaire
SSI (score) - Component of Seasonal Pattern Assessment Questionnaire	seasonality index (sum of test score of Component 11 of Seasonal Pattern Assessment Questionnaire)	about 10-15 minutes on each Questionnaire
SAD (nominal) - Component of Seasonal Pattern Assessment Questionnaire - seasonal affective disorder	nominal finding of the seasonal affective disorder	about 10-15 minutes on each Questionnaire
selfSAD (nominal) - Component of Seasonal Pattern Assessment Questionnaire	self-assessment by the subject of changes in his state depending on the season	about 10-15 minutes on each Questionnaire

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SI (c.u.)- stress index,	reflects the degree of stress in regulatory systems.	5 minutes
IC (c.u.)- centralization index,	reflects the degree of activity of central regulation circuit	5 minutes
PHF, (%) - power of the spectrum of the high-frequency component of variability in % of the total power of oscillations	evaluates the relative level of activity of the parasympathetic link of regulation	5 minutes
PLF, (%) - power of the spectrum of the low-frequency component of variability in% of the total power of oscillations	evaluates the relative level of activity of the vasomotor center	5 minutes
PVLF, (%) - power of the spectrum of the very low-frequency component of variability in% of the total power of oscillations	evaluates the relative level of activity of the sympathetic link of regulation	5 minutes
psqi10 (score) - Component of Pittsburgh Sleep Quality Index	having a roommate	about 10-15 minutes on each Questionnaire
psqi11 (a-e) (score) - Component of Pittsburgh Sleep Quality Index	ask your roommate how often you have: (a)loud snoring, (b) prolonged breath holding during sleep, (c) episodes of disorientation during sleep, (d) other manifestations of anxiety during sleep	about 10-15 minutes on each Questionnaire
psqi11cause - Component of Pittsburgh Sleep Quality Index	describe other manifestations of anxiety during sleep	about 10-15 minutes on each Questionnaire

Collaborators and Investigators

• Sponsor: Vladikavkaz Scientific Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Fatima Sergeevna Datieva, MD, Vladikavkaz Scientific Centre of the Russian Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: metabolic syndrome; sleep quality; public health; chronotype; physiological stress; seasonal pattern; regulatory systems
• Other Study ID Numbers: 1/7.20.03.21

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