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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Conditionally Healthy Persons
- Sponsor
- Vladikavkaz Scientific Center of the Russian Academy of Sciences
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- FEV1, (liters per second) - forced expiratory volume in the first second of the forced expiratory maneuver
- Last Updated
- 5 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
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
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
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.
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
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.
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
Secondary Outcomes
- psqi11 (a-e) (score) - Component of Pittsburgh Sleep Quality Index(about 10-15 minutes on each Questionnaire)
- SI (c.u.)- stress index,(5 minutes)
- IC (c.u.)- centralization index,(5 minutes)
- PHF, (%) - power of the spectrum of the high-frequency component of variability in % of the total power of oscillations(5 minutes)
- PLF, (%) - power of the spectrum of the low-frequency component of variability in% of the total power of oscillations(5 minutes)
- PVLF, (%) - power of the spectrum of the very low-frequency component of variability in% of the total power of oscillations(5 minutes)
- psqi10 (score) - Component of Pittsburgh Sleep Quality Index(about 10-15 minutes on each Questionnaire)
- psqi11cause - Component of Pittsburgh Sleep Quality Index(about 10-15 minutes on each Questionnaire)