Conditionally Healthy Persons Clinical Trial
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
| NCT number | NCT04851080 |
| Other study ID # | 1/7.20.03.21 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2019 |
| Est. completion date | December 2021 |
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.
| Status | Recruiting |
| Enrollment | 370 |
| Est. completion date | December 2021 |
| Est. primary completion date | May 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 13 Years to 57 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Institute of Biomedical Investigations - the Affilliate of Vladikavkaz Scientific Centre of the Russian Academy of Sciences | Vladikavkaz | RNO-Alania |
| Lead Sponsor | Collaborator |
|---|---|
| Vladikavkaz Scientific Center of the Russian Academy of Sciences |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | H, (kg) | height | 5 minutes | |
| Primary | W, (m) | weight | 5 minutes | |
| Primary | WC (cm) | waist circumference | 5 minutes | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | HF, (ms2) - power in high frequency range (0.15-0.4 Hz) | reflects the parasympathetic link of regulation | 5 minutes | |
| Primary | 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 | |
| Primary | TP, (ms2) - total power of the heart rate variability spectrum | reflects the total power of the heart rate variability spectrum | 5 minutes | |
| Primary | 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) | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | SI (c.u.)- stress index, | reflects the degree of stress in regulatory systems. | 5 minutes | |
| Secondary | IC (c.u.)- centralization index, | reflects the degree of activity of central regulation circuit | 5 minutes | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | psqi10 (score) - Component of Pittsburgh Sleep Quality Index | having a roommate | about 10-15 minutes on each Questionnaire | |
| Secondary | 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 | |
| Secondary | psqi11cause - Component of Pittsburgh Sleep Quality Index | describe other manifestations of anxiety during sleep | about 10-15 minutes on each Questionnaire |