Conditionally Healthy PersonsNCT04851080
Medico-ecological Monitoring ((CSM, MCTQ, SPAQ, PSQI, HRV, Spirometry; Anthropometry, BP) of the Different Population Groups (Students, Schoolchildren, Volunteers) in North Caucasus
An observational study of Conditionally Healthy Persons and Persons With a High Body Mass Index, run by Vladikavkaz Scientific Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditionally Healthy Persons, Persons With a High Body Mass Index
- What is being tested?
- Heart Rate Variability, Spirometry and Testing of psycho-physiological functions using four questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 370 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 57 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: population of the North Caucasus
Who may be able to join
- conditionally healthy persons, persons with metabolic disorders in the presence of basic criterion MS - abdominal obesity.
Who cannot join
- chronic somatic diseases; infectious diseases; malignant neoplasms of various organs and systems; viral infections; autoimmune diseases; mental illness; pregnancy and lactation in women
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Institute of Biomedical Investigations - the Affilliate of Vladikavkaz Scientific Centre of the Russian Academy of Sciences
Vladikavkaz, RNO-Alania, 362025
Larisa Ruslanovna Datieva, PhD, +7(672)539629, institutbmi@mail.ru
About this study
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
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.
Read the 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
- Being tested
- Heart Rate Variability, Spirometry, Testing of psycho-physiological functions using four questionnaires
- Keywords
- public health, metabolic syndrome, chronotype, sleep quality, seasonal pattern, regulatory systems, physiological stress
- Medical subject headings
- Metabolic Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate VariabilityDevice
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.
SpirometryDevice
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.
Testing of psycho-physiological functions using four questionnairesBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Schoolchildren | Schoolchildren of Vladikavkaz secondary schools aged 13-16 years Receives: Device: Heart Rate Variability; Device: Spirometry; Behavioral: Testing of psycho-physiological functions using four questionnaires | |
| Students | Students of North-Ossetian State Medical Academy at the age of 19-22 years Receives: Device: Heart Rate Variability; Device: Spirometry; Behavioral: Testing of psycho-physiological functions using four questionnaires | |
| Volunteers | Scientists of the North Caucasian Research Institute of Mountain and Foothill Agriculture at the age of 30-56 years Receives: Device: Heart Rate Variability; Device: Spirometry; Behavioral: Testing of psycho-physiological functions using four questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
H, (kg)
height
Measured: 5 minutes
W, (m)
weight
Measured: 5 minutes
WC (cm)
waist circumference
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 5 minutes
HF, (ms2) - power in high frequency range (0.15-0.4 Hz)
reflects the parasympathetic link of regulation
Measured: 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
Measured: 5 minutes
TP, (ms2) - total power of the heart rate variability spectrum
reflects the total power of the heart rate variability spectrum
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: about 10-15 minutes on each Questionnaire
Secondary outcomes (8)
SI (c.u.)- stress index,
reflects the degree of stress in regulatory systems.
Measured: 5 minutes
IC (c.u.)- centralization index,
reflects the degree of activity of central regulation circuit
Measured: 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
Measured: 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
Measured: 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
Measured: 5 minutes
psqi10 (score) - Component of Pittsburgh Sleep Quality Index
having a roommate
Measured: 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
Measured: about 10-15 minutes on each Questionnaire
psqi11cause - Component of Pittsburgh Sleep Quality Index
describe other manifestations of anxiety during sleep
Measured: about 10-15 minutes on each Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Apr 2019
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditionally Healthy PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vladikavkaz Scientific Center of the Russian Academy of Sciences
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Fatima Sergeevna Datieva, MD, Principal investigator, Vladikavkaz Scientific Centre of the Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851080
- Sponsor's protocol ID
- 1/7.20.03.21
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04851080
- Acronym / sponsor ID
- 1/7.20.03.21
- Keywords
- public health, metabolic syndrome, chronotype, sleep quality, seasonal pattern, regulatory systems, physiological stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Vladikavkaz Scientific Center of the Russian Academy of SciencesResearch network
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schoolchildren | – | Device: Heart Rate Variability, Device: Spirometry, Behavioral: Testing of psycho-physiological functions using four questionnairesSchoolchildren of Vladikavkaz secondary schools aged 13-16 years |
| Students | – | Device: Heart Rate Variability, Device: Spirometry, Behavioral: Testing of psycho-physiological functions using four questionnairesStudents of North-Ossetian State Medical Academy at the age of 19-22 years |
| Volunteers | – | Device: Heart Rate Variability, Device: Spirometry, Behavioral: Testing of psycho-physiological functions using four questionnairesScientists of the North Caucasian Research Institute of Mountain and Foothill Agriculture at the age of 30-56 years |
Who may qualify
- Ages
- 13 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- population of the North Caucasus
Key inclusion criteria (1 listed)
- conditionally healthy persons, persons with metabolic disorders in the presence of basic criterion MS - abdominal obesity.
Key exclusion criteria (1 listed)
- chronic somatic diseases; infectious diseases; malignant neoplasms of various organs and systems; viral infections; autoimmune diseases; mental illness; pregnancy and lactation in women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate VariabilityHeart 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 | Schoolchildren, Students, Volunteers |
| SpirometrySpirometry 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. | Device | Schoolchildren, Students, Volunteers |
| Testing of psycho-physiological functions using four questionnairesResearch 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) | Behavioural | Schoolchildren, Students, Volunteers |
Primary outcome
H, (kg)
Time frame: 5 minutes
height
W, (m)
Time frame: 5 minutes
weight
WC (cm)
Time frame: 5 minutes
waist circumference
HR (beats per minute) - frequency of the pulse
Time frame: 5 minutes
average pulse rate over the observation period, which integrally characterizes the level of functioning of the circulatory system.
SDNN, (ms) - standard deviation of all NN intervals
Time frame: 5 minutes
reflects all the cyclic components responsible for variability and the total effect of autonomic regulation of blood circulation
RMSSD, (ms) - square root of the mean of the sum of the squares of differences between adjacent NN intervals
Time frame: 5 minutes
measurements of short-term variation, estimate high frequency variations in heart rate and activity of the parasympathetic link of regulation.
pNN50, (ms)
Time frame: 5 minutes
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
LF, (ms2) - power in low frequency range (0.04-0.15 Hz)
Time frame: 5 minutes
reflects the state of the sympathetic from the case of the ANS, and, in part, the parasympathetic department
HF, (ms2) - power in high frequency range (0.15-0.4 Hz)
Time frame: 5 minutes
reflects the parasympathetic link of regulation
LF/HF - ratio LF (ms2)/HF (ms2)
Time frame: 5 minutes
reflects the ratio of the levels of activity of the central and autonomous circuits of regulation
TP, (ms2) - total power of the heart rate variability spectrum
Time frame: 5 minutes
reflects the total power of the heart rate variability spectrum
FVCL, (liter) - forced vital capacity of lungs
Time frame: individually (at least six seconds)
qualifies the maximum volume of air that a person can exhale after taking the deepest possible breath
FEV1, (liters per second) - forced expiratory volume in the first second of the forced expiratory maneuver
Time frame: 1 second
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
mun-wd-fas (hours:minutes) - falling asleep time on working days
Time frame: about 10-15 minutes on each Questionnaire
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.
mun-wd (hours:minutes) - sleep duration on working days
Time frame: about 10-15 minutes on each Questionnaire
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.
mun-wd-mid (hours:minutes) - middle of sleep duration on working days
Time frame: about 10-15 minutes on each Questionnaire
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.
mun-wd-wut (hours:minutes) - wake up time on working days
Time frame: about 10-15 minutes on each Questionnaire
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.
mun-fd-fas (hours:minutes) - falling asleep time on weekend days
Time frame: about 10-15 minutes on each Questionnaire
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.
mun-fd (hours:minutes) - sleep duration on weekend days
Time frame: about 10-15 minutes on each Questionnaire
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.
mun-fd-mid (hours:minutes) - middle of sleep duration on weekend days
Time frame: about 10-15 minutes on each Questionnaire
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.
mun-fd-wut (hours:minutes) - wake up time on weekend days
Time frame: about 10-15 minutes on each Questionnaire
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.
DEW (hours:minutes) - daylight exposure on working days
Time frame: about 10-15 minutes on each Questionnaire
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.
DEF (hours:minutes) - daylight exposure on weekend days
Time frame: about 10-15 minutes on each Questionnaire
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.
JLW (hours:minutes) - jet lag on working days
Time frame: about 10-15 minutes on each Questionnaire
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.
JLF (hours:minutes) - jet lag on weekend days
Time frame: about 10-15 minutes on each Questionnaire
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.
C1 (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
"Daytime mood": how much (score) of a problem has it been to keep up enthusiasm to get things done during the past month
C2 (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
"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)
C3 (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
"Sleep duration": hours of actual sleep at night (>7=0; 6-7=1; 5-6=2; <5=3)
C4 (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
"Sleep efficiency": (total of hours asleep)/(total of hours in bed) x 100; >85%=0, 75%-84%=1, 65%-74%=2, <65%=3
C5 (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
"Sleep disturbance": sum of Component 5b-5j scores (0=0; 1-9=1; 10-18=2; 19-27=3)
C6 (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
"Subjective sleep quality": self-reported sleep quality over the past month
C7(score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
"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
Global PSQI Score = C1+C2+C3+C4+C5+C6+C7
Time frame: about 10-15 minutes on each Questionnaire
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.
CMQ (score) - Component of Composite Scale of Morningness
Time frame: about 10-15 minutes on each Questionnaire
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.
CSMN (nominal) - Component of Composite Scale of Morningness
Time frame: about 10-15 minutes on each Questionnaire
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.
SSI (score) - Component of Seasonal Pattern Assessment Questionnaire
Time frame: about 10-15 minutes on each Questionnaire
seasonality index (sum of test score of Component 11 of Seasonal Pattern Assessment Questionnaire)
SAD (nominal) - Component of Seasonal Pattern Assessment Questionnaire - seasonal affective disorder
Time frame: about 10-15 minutes on each Questionnaire
nominal finding of the seasonal affective disorder
selfSAD (nominal) - Component of Seasonal Pattern Assessment Questionnaire
Time frame: about 10-15 minutes on each Questionnaire
self-assessment by the subject of changes in his state depending on the season
8 secondary outcomes
SI (c.u.)- stress index,
Time frame: 5 minutes
IC (c.u.)- centralization index,
Time frame: 5 minutes
PHF, (%) - power of the spectrum of the high-frequency component of variability in % of the total power of oscillations
Time frame: 5 minutes
PLF, (%) - power of the spectrum of the low-frequency component of variability in% of the total power of oscillations
Time frame: 5 minutes
PVLF, (%) - power of the spectrum of the very low-frequency component of variability in% of the total power of oscillations
Time frame: 5 minutes
psqi10 (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
psqi11 (a-e) (score) - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
psqi11cause - Component of Pittsburgh Sleep Quality Index
Time frame: about 10-15 minutes on each Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Sergeevna Datieva, MD principal investigator
Vladikavkaz Scientific Centre of the Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conditionally Healthy Persons and Persons With a High Body Mass Index, run by Vladikavkaz Scientific Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Larisa Ruslanovna Datieva, PhD (7(672)539629, institutbmi@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H, (kg) (time frame: 5 minutes). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.