Clinical trial NCT04851080: Medico-ecological Monitoring ((CSM, MCTQ, SPAQ, PSQI, HRV, Spirometry; Anthropometry, BP) of the Different Population Groups (Students, Schoolchildren, Volunteers) in North Caucasus
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Conditionally Healthy Persons
Persons With a High Body Mass Index
Keywords: public health
metabolic syndrome
chronotype
sleep quality
seasonal pattern
regulatory systems
physiological stress
Lead sponsor: Vladikavkaz Scientific Center of the Russian Academy of Sciences
Sponsor class: NETWORK
First posted: 2021-04-20
Enrollment: 370
Sex: ALL
Minimum age (years): 13
Maximum age (years): 57
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: population of the North Caucasus

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: H, (kg)
timeFrame: 5 minutes
measure: W, (m)
timeFrame: 5 minutes
measure: WC (cm)
timeFrame: 5 minutes
measure: HR (beats per minute) - frequency of the pulse
timeFrame: 5 minutes
measure: SDNN, (ms) - standard deviation of all NN intervals
timeFrame: 5 minutes
measure: RMSSD, (ms) - square root of the mean of the sum of the squares of differences between adjacent NN intervals
timeFrame: 5 minutes
measure: pNN50, (ms)
timeFrame: 5 minutes
measure: LF, (ms2) - power in low frequency range (0.04-0.15 Hz)
timeFrame: 5 minutes
measure: HF, (ms2) - power in high frequency range (0.15-0.4 Hz)
timeFrame: 5 minutes
measure: LF/HF - ratio LF (ms2)/HF (ms2)
timeFrame: 5 minutes
measure: TP, (ms2) - total power of the heart rate variability spectrum
timeFrame: 5 minutes
measure: FVCL, (liter) - forced vital capacity of lungs
timeFrame: individually (at least six seconds)
measure: FEV1, (liters per second) - forced expiratory volume in the first second of the forced expiratory maneuver
timeFrame: 1 second
measure: mun-wd-fas (hours:minutes) - falling asleep time on working days
timeFrame: about 10-15 minutes on each Questionnaire
measure: mun-wd (hours:minutes) - sleep duration on working days
timeFrame: about 10-15 minutes on each Questionnaire
measure: mun-wd-mid (hours:minutes) - middle of sleep duration on working days
timeFrame: about 10-15 minutes on each Questionnaire
measure: mun-wd-wut (hours:minutes) - wake up time on working days
timeFrame: about 10-15 minutes on each Questionnaire
measure: mun-fd-fas (hours:minutes) - falling asleep time on weekend days
timeFrame: about 10-15 minutes on each Questionnaire
measure: mun-fd (hours:minutes) - sleep duration on weekend days
timeFrame: about 10-15 minutes on each Questionnaire
measure: mun-fd-mid (hours:minutes) - middle of sleep duration on weekend days
timeFrame: about 10-15 minutes on each Questionnaire
measure: mun-fd-wut (hours:minutes) - wake up time on weekend days
timeFrame: about 10-15 minutes on each Questionnaire
measure: DEW (hours:minutes) - daylight exposure on working days
timeFrame: about 10-15 minutes on each Questionnaire
measure: DEF (hours:minutes) - daylight exposure on weekend days
timeFrame: about 10-15 minutes on each Questionnaire
measure: JLW (hours:minutes) - jet lag on working days
timeFrame: about 10-15 minutes on each Questionnaire
measure: JLF (hours:minutes) - jet lag on weekend days
timeFrame: about 10-15 minutes on each Questionnaire
measure: C1 (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: C2 (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: C3 (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: C4 (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: C5 (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: C6 (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: C7(score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: Global PSQI Score = C1+C2+C3+C4+C5+C6+C7
timeFrame: about 10-15 minutes on each Questionnaire
measure: CMQ (score) - Component of Composite Scale of Morningness
timeFrame: about 10-15 minutes on each Questionnaire
measure: CSMN (nominal) - Component of Composite Scale of Morningness
timeFrame: about 10-15 minutes on each Questionnaire
measure: SSI (score) - Component of Seasonal Pattern Assessment Questionnaire
timeFrame: about 10-15 minutes on each Questionnaire
measure: SAD (nominal) - Component of Seasonal Pattern Assessment Questionnaire - seasonal affective disorder
timeFrame: about 10-15 minutes on each Questionnaire
measure: selfSAD (nominal) - Component of Seasonal Pattern Assessment Questionnaire
timeFrame: about 10-15 minutes on each Questionnaire
Secondary outcomes:
measure: SI (c.u.)- stress index,
timeFrame: 5 minutes
measure: IC (c.u.)- centralization index,
timeFrame: 5 minutes
measure: PHF, (%) - power of the spectrum of the high-frequency component of variability in % of the total power of oscillations
timeFrame: 5 minutes
measure: PLF, (%) - power of the spectrum of the low-frequency component of variability in% of the total power of oscillations
timeFrame: 5 minutes
measure: PVLF, (%) - power of the spectrum of the very low-frequency component of variability in% of the total power of oscillations
timeFrame: 5 minutes
measure: psqi10 (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: psqi11 (a-e) (score) - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
measure: psqi11cause - Component of Pittsburgh Sleep Quality Index
timeFrame: about 10-15 minutes on each Questionnaire
Other outcomes:
Locations:
city: Vladikavkaz
country: Russian Federation
facility: Institute of Biomedical Investigations - the Affilliate of Vladikavkaz Scientific Centre of the Russian Academy of Sciences
state: RNO-Alania
Study officials:
affiliation: Vladikavkaz Scientific Centre of the Russian Academy of Sciences
name: Fatima Sergeevna Datieva, MD
role: PRINCIPAL_INVESTIGATOR
References: