Clinical trial NCT03453398: Effects of Shift Work on Nurse Staff Health
Official title: Effects of Shift Work on Health: Assessment of Sleep Quality, Motor Control and Cardiovascular Risk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift Work Type Circadian Rhythm Sleep Disorder
Chronobiology Disorders
Mood Swing
Physical Activity
Cardiovascular Diseases
Keywords: Chronotype
Shift work
Health status
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are divided in three different groups on the bases of their actual shift work modalities. Thus no allocation process is possible within this project.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Work shift continuity in a specific group of at least one year.

Exclusion Criteria:

* Presence of cardiovascular, endocrine or metabolic diseases;
* Presence of neurological or musculoskeletal impairments at finger flexors muscles level;
* Pharmacological therapies in place that can affect the heart rate and the sleep quality;
* Self-declaration of pregnancy.

Primary outcomes:
measure: Sleep Efficiency (SE)
timeFrame: 8 days
measure: Sleep Latency (SL)
timeFrame: 8 days
measure: Movement and Fragmentation Index (MFI)
timeFrame: 8 days
measure: Immobile Time (IT)
timeFrame: 8 days
measure: Assumed Sleep (AS)
timeFrame: 8 days
Secondary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: Baseline and 8 days
measure: Finger flexor muscles maximum voluntary contraction (MVC)
timeFrame: Baseline and 8 days
measure: Force coefficient of variation (CV)
timeFrame: Baseline and 8 days
measure: Distance of the force signal (DF)
timeFrame: Baseline and 8 days
measure: Surface electromyography (sEMG) root mean square (RMS) of finger flexor muscles
timeFrame: Baseline and 8 days
measure: Surface electromyography (sEMG) mean frequency (MF) of finger flexor muscles
timeFrame: Baseline and 8 days
measure: Hearth Rate Variability (HRV)
timeFrame: Baseline and 8 days
Other outcomes:
measure: Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline
measure: QRISK2-2017 questionnaire
timeFrame: Baseline
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
state: MI
Study officials:
affiliation: University of Milan
name: Fabio Esposito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adan A, Archer SN, Hidalgo MP, Di Milia L, Natale V, Randler C. Circadian typology: a comprehensive review. Chronobiol Int. 2012 Nov;29(9):1153-75. doi: 10.3109/07420528.2012.719971. Epub 2012 Sep 24.
citation: Akerstedt T. Shift work and disturbed sleep/wakefulness. Sleep Med Rev. 1998 May;2(2):117-28. doi: 10.1016/s1087-0792(98)90004-1.
citation: Boivin DB, Tremblay GM, James FO. Working on atypical schedules. Sleep Med. 2007 Sep;8(6):578-89. doi: 10.1016/j.sleep.2007.03.015. Epub 2007 May 3.
citation: Costa G, Anelli MM, Castellini G, Fustinoni S, Neri L. Stress and sleep in nurses employed in "3 x 8" and "2 x 12" fast rotating shift schedules. Chronobiol Int. 2014 Dec;31(10):1169-78. doi: 10.3109/07420528.2014.957309. Epub 2014 Sep 12.
citation: Guo Y, Liu Y, Huang X, Rong Y, He M, Wang Y, Yuan J, Wu T, Chen W. The effects of shift work on sleeping quality, hypertension and diabetes in retired workers. PLoS One. 2013 Aug 16;8(8):e71107. doi: 10.1371/journal.pone.0071107. eCollection 2013.
citation: Halberg F, Carandente F, Cornelissen G, Katinas GS. [Glossary of chronobiology (author's transl)]. Chronobiologia. 1977;4 Suppl 1:1-189. No abstract available. Italian.
citation: Harma M. Individual differences in tolerance to shiftwork: a review. Ergonomics. 1993 Jan-Mar;36(1-3):101-9. doi: 10.1080/00140139308967860.
citation: Hippisley-Cox J, Coupland C, Robson J, Brindle P. Derivation, validation, and evaluation of a new QRISK model to estimate lifetime risk of cardiovascular disease: cohort study using QResearch database. BMJ. 2010 Dec 9;341:c6624. doi: 10.1136/bmj.c6624.
citation: Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, Minhas R, Sheikh A, Brindle P. Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2. BMJ. 2008 Jun 28;336(7659):1475-82. doi: 10.1136/bmj.39609.449676.25. Epub 2008 Jun 23.
citation: Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
citation: Juda M, Vetter C, Roenneberg T. Chronotype modulates sleep duration, sleep quality, and social jet lag in shift-workers. J Biol Rhythms. 2013 Apr;28(2):141-51. doi: 10.1177/0748730412475042.
citation: Martin JS, Laberge L, Sasseville A, Berube M, Alain S, Houle J, Hebert M. Day and night shift schedules are associated with lower sleep quality in Evening-types. Chronobiol Int. 2015 Jun;32(5):627-36. doi: 10.3109/07420528.2015.1033425. Epub 2015 Jun 2.
citation: Montaruli A, Galasso L, Caumo A, Cè E, Pesenti C, Roveda E, Esposito F. (2017). The circadian typology: the role of physical activity and melatonin. Sport Sciences for Health 1-8, 2017
citation: Montaruli A, Galasso L, Carandente F, Vitale JA, Roveda E, Caumo A. If the Morning-Evening Questionnaire (MEQ) is able to predict the actigraphy-based acrophase, how does its reduced, five-item version (rMEQ) perform? Chronobiol Int. 2017;34(4):443-444. doi: 10.1080/07420528.2017.1306708. No abstract available.
citation: Nelson W, Tong YL, Lee JK, Halberg F. Methods for cosinor-rhythmometry. Chronobiologia. 1979 Oct-Dec;6(4):305-23. No abstract available.
citation: Newey CA, Hood BM. Determinants of shift-work adjustment for nursing staff: the critical experience of partners. J Prof Nurs. 2004 May-Jun;20(3):187-95. doi: 10.1016/j.profnurs.2004.04.007.
citation: Rajaratnam SM, Arendt J. Health in a 24-h society. Lancet. 2001 Sep 22;358(9286):999-1005. doi: 10.1016/S0140-6736(01)06108-6.
citation: Roveda E, Vitale JA, Bruno E, Montaruli A, Pasanisi P, Villarini A, Gargano G, Galasso L, Berrino F, Caumo A, Carandente F. Protective Effect of Aerobic Physical Activity on Sleep Behavior in Breast Cancer Survivors. Integr Cancer Ther. 2017 Mar;16(1):21-31. doi: 10.1177/1534735416651719. Epub 2016 Jun 1.
citation: Roveda E, Vitale J, Montaruli A, Galasso L, Carandente F, Caumo A. Predicting the actigraphy-based acrophase using the Morningness-Eveningness Questionnaire (MEQ) in college students of North Italy. Chronobiol Int. 2017;34(5):551-562. doi: 10.1080/07420528.2016.1276928. Epub 2017 Feb 21.
citation: Saksvik IB, Bjorvatn B, Hetland H, Sandal GM, Pallesen S. Individual differences in tolerance to shift work--a systematic review. Sleep Med Rev. 2011 Aug;15(4):221-35. doi: 10.1016/j.smrv.2010.07.002. Epub 2010 Sep 20.
citation: Schernhammer ES, Laden F, Speizer FE, Willett WC, Hunter DJ, Kawachi I, Colditz GA. Rotating night shifts and risk of breast cancer in women participating in the nurses' health study. J Natl Cancer Inst. 2001 Oct 17;93(20):1563-8. doi: 10.1093/jnci/93.20.1563.
citation: Munakata M, Ichi S, Nunokawa T, Saito Y, Ito N, Fukudo S, Yoshinaga K. Influence of night shift work on psychologic state and cardiovascular and neuroendocrine responses in healthy nurses. Hypertens Res. 2001 Jan;24(1):25-31. doi: 10.1291/hypres.24.25.
citation: Galasso L, Mule A, Castelli L, Ce E, Condemi V, Banfi G, Roveda E, Montaruli A, Esposito F. Effects of Shift Work in a Sample of Italian Nurses: Analysis of Rest-Activity Circadian Rhythm. Int J Environ Res Public Health. 2021 Aug 8;18(16):8378. doi: 10.3390/ijerph18168378.