An interventional study of Shifts working hours with different schedules in Shift Work Type Circadian Rhythm Sleep Disorder, Chronobiology Disorders and Mood Swing, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Not applicable, Interventional, and Other
Shift work deeply impacts on temporal organization leading to a circadian desynchronization, which translates into a worsening of the sleep quality and work ability during waking hours. Furthermore, also the fine motor control skills and the subjective mood profile could undergo modifications in relation to the acquired sleep debt. The misalignment between working time and physiological/behavioral functions could have negative influences on the levels of spontaneous daily activity, with possible alteration of the activity-rest rhythm of the worker, especially in clinics.
In relation to the participants' chronotype, the aim of this project will be to evaluate the effect of irregular working hours (shift work) on (i) the sleep quality, (ii) the circadian rhythm of activity levels and, (iii) the motor control. These assessments will help to identify the shift type with less impact on the health status in a nurse cohort.
Shift work can exert numerous effects on the temporal and behavioral organization of the individuals. Working hours of shift workers, which are outside the normal daily social program, lead to a circadian desynchronization due to a temporary misalignment between working time and physiological and behavioral functions, similarly to what is observed in the jet lag syndrome. This may lead to deterioration in the sleep quality, reduction in the working ability during waking hours, with sleepiness and a reduction in the vigilance state.
Over the years, the impact of shift work has involved many areas and its effects have been investigated at the cardiovascular (coronary artery disease, hypertension), metabolic (diabetes and obesity) and immunological level. Several investigations provided evidence of the shift work-induced negative results on health, including carcinogenic effects. Consequently, the scientific community paid to these problems great attention.
In analyzing the health effects of shift work, the chronotype of the workers, or their circadian typology, is very important. In fact, the circadian rhythms represent a dimension of the human personality that should not be underestimated. The human being has a temporal organization, determined by the interaction of endogenous and environmental factors, and organizes most of the biological and behavioral activities according to a twenty-four hour period and in sync with the light-dark cycle. It is not worthy to mention that the biological rhythms in humans present interindividual differences that determine precisely the chronotype, which is the tendency to express preferences toward morning or evening activities. Within the population, it is possible to recognize subjects that can be traced to three circadian types: (i) morning-types subjects (M-Types) that tend to be more active and efficient in the first part of the day, (ii) evening-types subjects (E-Types) who find it difficult to get up in the morning and require more time to reach the optimal level of physical and mental efficiency, and (iii) intermediate subjects (Neither-Types, N-Types) that present intermediate characteristics between the previous two.
Previous studies suggested that the eveningness could determine an easier adaptability to the changes determined by shift work. However, the role of the chronotype on this aspect is yet to be related to the type of shift: on one side, the E-Types tend to have more sleep disorders induced by a diurnal working shift. On the other side, the M-Types tend to adapt worst to a night working shift. In any case, shift work determines a growing sleep debt that can have a not negligible impact on the wellbeing and health of the individual.
The association between shift work and cardiovascular risk is very interesting. Sleep at night, in fact, can have important effects on blood pressure. Some studies have shown that a good sleep quality may have potential effects in the prevention of hypertension. Arterial pressure decreases by an average of 10-20% during nighttime hours, so sleep debt could lead to higher average blood pressure over the course of twenty-four hours. In addition, by modifying the circadian rhythms, the shift may lead to an alteration of the autonomic nervous system regulation with hypertensive consequences.
This project will focus on a particular category of shift workers, i.e., the nurse staff working in a hospital. Nurse staff has three different shift schedules: (i) shift changes every day (the first day from 7.00 to 14.00, the second day from 14.00 to 21.00, the third day from 21.00 to 7.00, the fourth day night off and, the fifth day rest), with a "shift cycle" duration of 5 days; (ii) shift changes every two days (first and second day from 7.00 to 14.00, third and fourth day from 14.00 to 21.00, fifth day rest, sixth and seventh day from 21.00 to 7.00, eighth day night off and ninth and tenth day rest), with a shift cycle of 10 days; and (iii) only diurnal shifts (first day from 7.00 to 14.00 and the second day from 14.00 to 21.00), with 2 days of rest every 5 work days.
To this purpose, the aim of this project will be to identify the type of shift work schedule with less impact on the state of health of the hospital staff by evaluating the effect of different shift work schedules on the quality of sleep, on the circadian rhythm of activity levels and on motor control, in relation to the participants' chronotype.
102 studies on the registry are indexed under Chronobiology Disorders; 22 are open to participants now.
This study's enrollment of 71 is close to the median of 70 across 68 interventional studies indexed under Chronobiology Disorders.
Browse Chronobiology Disorders studies →I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Shifts over 24-hours, shift cycle of 5 days (morning, afternoon, night, night off, rest).
Other: Shifts working hours with different schedules
Shifts over 24-hours, shift cycle of 10 days (morning, morning, afternoon, afternoon, rest, night, night, night off, rest, rest).
Other: Shifts working hours with different schedules
Only diurnal shifts, shift cycle of 5 days (morning, afternoon, morning, afternoon, morning, rest, rest).
Other: Shifts working hours with different schedules
Workers in Group 1, 2, and 3 will undergo three different shift work modalities presenting different schedules. Importantly, as an inclusion criteria, workers have to be involved in the same shift modality for at least one year at the time at the beginning of the study.
Sleep Efficiency (SE)
Percentage of time spent in bed with actual sleep
Time frame: 8 days
Sleep Latency (SL)
period of time between bed and sleep
Time frame: 8 days
Movement and Fragmentation Index (MFI)
Percentage of time spent moving indicative of the fragmentation of sleep
Time frame: 8 days
Immobile Time (IT)
total time spent without movement, between sleep from start to sleep
Time frame: 8 days
Assumed Sleep (AS)
Difference between beginning and end of sleep
Time frame: 8 days
Profile of Mood States (POMS)
Questionnaire for the determination of the mood profile
Time frame: Baseline and 8 days
Finger flexor muscles maximum voluntary contraction (MVC)
Evaluation of the maximum isometric force output of the finger flexors muscles
Time frame: Baseline and 8 days
Force coefficient of variation (CV)
Ratio between the standard deviation of the force signal during the plateau phase and the mean of the force signal (index of muscle contraction stability)
Time frame: Baseline and 8 days
Distance of the force signal (DF)
distance of the force signal with respect to the target (index of force accuracy )
Time frame: Baseline and 8 days
Surface electromyography (sEMG) root mean square (RMS) of finger flexor muscles
Index of muscle activation reflecting the number of recruited motor units during contraction
Time frame: Baseline and 8 days
Surface electromyography (sEMG) mean frequency (MF) of finger flexor muscles
Index reflecting the mean rate of activation of the recruited motor units during contraction
Time frame: Baseline and 8 days
Hearth Rate Variability (HRV)
Quantification of the sympatho-vagal balance
Time frame: Baseline and 8 days
Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
Questionnaire for chronotype determination.The MEQ has 19 items, and the answer options include using a visual analog scale and choosing between four or five options. Participants are classified as Morning-types (scores between 59 and 86), Neither-types (scores between 42 and 58), and Evening-types (scores between 16 and 41).
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ)
Questionnaire for the assessment of the level of physical activity. The number of days and minutes in a week dedicated at walking or in moderate or heavy physical activities are converted in metabolic equivalent units (METs). The sum of the METs identifies the level of physical activity: METs \< 700 = inactive; METs from 700 to 2519 = adequately active; METs \> 2519 highly active.
Time frame: Baseline
QRISK2-2017 questionnaire
Questionnaire for cardiovascular risk assessment. The questionnaire provides a score (in percentage) of the risk of having a heart attack or stroke within the next 10 years. Score ranges from 0.1% (lowest risk) and 100% (maximum risk).
Time frame: Baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymous individual participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available within 6 months from the end of the study.
Access criteria: Data access request will be reviewed by the principal investigator and co-investigators. Requestors will be required to sign a Data Access Agreement.
Ran from Jan 2018 to primary completion in Dec 2019, 23 months.
Of 43 non-industry interventional studies with no phase under Chronobiology Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's 23 months is below that.
Counting every sponsor, half of 45 studies reached it within 30 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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