Shift Work Type Circadian Rhythm Sleep DisorderTurnistiNCT03453398
Effects of Shift Work on Nurse Staff Health
A study testing Shifts working hours with different schedules in people with Shift Work Type Circadian Rhythm Sleep Disorder and Chronobiology Disorders, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift Work Type Circadian Rhythm Sleep Disorder, Chronobiology Disorders, Mood Swing
- What is being tested?
- Shifts working hours with different schedules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jan 2018to 15 Jan 2020
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Work shift continuity in a specific group of at least one year.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Shift Work on Health: Assessment of Sleep Quality, Motor Control and Cardiovascular Risk.
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.
Read the 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.
- Conditions
- Shift Work Type Circadian Rhythm Sleep Disorder, Chronobiology Disorders, Mood Swing, Physical Activity, Cardiovascular Diseases
- Being tested
- Shifts working hours with different schedules
- Keywords
- Chronotype, Shift work, Health status
- Medical subject headings
- Chronobiology Disorders, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shifts working hours with different schedulesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Shifts over 24-hours, shift cycle of 5 days (morning, afternoon, night, night off, rest). Receives: Other: Shifts working hours with different schedules |
| Group 2 | Experimental | Shifts over 24-hours, shift cycle of 10 days (morning, morning, afternoon, afternoon, rest, night, night, night off, rest, rest). Receives: Other: Shifts working hours with different schedules |
| Group 3 | Active comparator | Only diurnal shifts, shift cycle of 5 days (morning, afternoon, morning, afternoon, morning, rest, rest). Receives: Other: Shifts working hours with different schedules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency (SE)
Percentage of time spent in bed with actual sleep
Measured: 8 days
Sleep Latency (SL)
period of time between bed and sleep
Measured: 8 days
Movement and Fragmentation Index (MFI)
Percentage of time spent moving indicative of the fragmentation of sleep
Measured: 8 days
Immobile Time (IT)
total time spent without movement, between sleep from start to sleep
Measured: 8 days
Assumed Sleep (AS)
Difference between beginning and end of sleep
Measured: 8 days
Secondary outcomes (7)
Profile of Mood States (POMS)
Questionnaire for the determination of the mood profile
Measured: Baseline and 8 days
Finger flexor muscles maximum voluntary contraction (MVC)
Evaluation of the maximum isometric force output of the finger flexors muscles
Measured: 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)
Measured: Baseline and 8 days
Distance of the force signal (DF)
distance of the force signal with respect to the target (index of force accuracy )
Measured: 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
Measured: 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
Measured: Baseline and 8 days
Hearth Rate Variability (HRV)
Quantification of the sympatho-vagal balance
Measured: Baseline and 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start23 Jan 2018
- Primary completion30 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Shift Work Type Circadian Rhythm Sleep DisorderStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Esposito, MD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453398
- Sponsor's protocol ID
- Turnisti
- Acronym
- Turnisti
- Status last verified
- Jan 2020
- First submitted
- 7 Feb 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous individual participant data for all primary and secondary outcome measures will be made available
Publications
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.
PubMed 23004349Akerstedt T. Shift work and disturbed sleep/wakefulness. Sleep Med Rev. 1998 May;2(2):117-28. doi: 10.1016/s1087-0792(98)90004-1.
PubMed 15310506Boivin 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.
PubMed 17481949Costa 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.
PubMed 25216205Guo 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.
PubMed 23976988Halberg F, Carandente F, Cornelissen G, Katinas GS. [Glossary of chronobiology (author's transl)]. Chronobiologia. 1977;4 Suppl 1:1-189. No abstract available. Italian.
PubMed 352650Harma M. Individual differences in tolerance to shiftwork: a review. Ergonomics. 1993 Jan-Mar;36(1-3):101-9. doi: 10.1080/00140139308967860.
PubMed 8440205Hippisley-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.
PubMed 21148212Hippisley-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.
PubMed 18573856Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
PubMed 1027738Juda 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.
PubMed 23606613Martin 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.
PubMed 26035480Montaruli 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
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.
PubMed 28426388Nelson W, Tong YL, Lee JK, Halberg F. Methods for cosinor-rhythmometry. Chronobiologia. 1979 Oct-Dec;6(4):305-23. No abstract available.
PubMed 548245
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shift Work on Health: Assessment of Sleep Quality, Motor Control and Cardiovascular Risk.
- ClinicalTrials.gov ID
- NCT03453398
- Acronym / sponsor ID
- Turnisti / Turnisti
- Conditions
- Shift Work Type Circadian Rhythm Sleep Disorder, Chronobiology Disorders, Mood Swing, Physical Activity, Cardiovascular Diseases
- Keywords
- Chronotype, Shift work, Health status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 5 Mar 2018 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Shifts working hours with different schedulesShifts over 24-hours, shift cycle of 5 days (morning, afternoon, night, night off, rest). |
| Group 2 | Experimental | Other: Shifts working hours with different schedulesShifts over 24-hours, shift cycle of 10 days (morning, morning, afternoon, afternoon, rest, night, night, night off, rest, rest). |
| Group 3 | Active comparator | Other: Shifts working hours with different schedulesOnly diurnal shifts, shift cycle of 5 days (morning, afternoon, morning, afternoon, morning, rest, rest). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Work shift continuity in a specific group of at least one year.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Shifts working hours with different schedulesWorkers 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. | Other | Group 1, Group 2, Group 3 |
Primary outcome
Sleep Efficiency (SE)
Time frame: 8 days
Percentage of time spent in bed with actual sleep
Sleep Latency (SL)
Time frame: 8 days
period of time between bed and sleep
Movement and Fragmentation Index (MFI)
Time frame: 8 days
Percentage of time spent moving indicative of the fragmentation of sleep
Immobile Time (IT)
Time frame: 8 days
total time spent without movement, between sleep from start to sleep
Assumed Sleep (AS)
Time frame: 8 days
Difference between beginning and end of sleep
7 secondary outcomes
Profile of Mood States (POMS)
Time frame: Baseline and 8 days
Finger flexor muscles maximum voluntary contraction (MVC)
Time frame: Baseline and 8 days
Force coefficient of variation (CV)
Time frame: Baseline and 8 days
Distance of the force signal (DF)
Time frame: Baseline and 8 days
Surface electromyography (sEMG) root mean square (RMS) of finger flexor muscles
Time frame: Baseline and 8 days
Surface electromyography (sEMG) mean frequency (MF) of finger flexor muscles
Time frame: Baseline and 8 days
Hearth Rate Variability (HRV)
Time frame: Baseline and 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 23004349Adan 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.
- Background: PubMed 15310506Akerstedt T. Shift work and disturbed sleep/wakefulness. Sleep Med Rev. 1998 May;2(2):117-28. doi: 10.1016/s1087-0792(98)90004-1.
- Background: PubMed 17481949Boivin 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.
- Background: PubMed 25216205Costa 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.
- Background: PubMed 23976988Guo 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.
- Background: PubMed 352650Halberg F, Carandente F, Cornelissen G, Katinas GS. [Glossary of chronobiology (author's transl)]. Chronobiologia. 1977;4 Suppl 1:1-189. No abstract available. Italian.
- Background: PubMed 8440205Harma M. Individual differences in tolerance to shiftwork: a review. Ergonomics. 1993 Jan-Mar;36(1-3):101-9. doi: 10.1080/00140139308967860.
- Background: PubMed 21148212Hippisley-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.
- Background: PubMed 18573856Hippisley-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.
- Background: PubMed 1027738Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
- Background: PubMed 23606613Juda 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.
- Background: PubMed 26035480Martin 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.
- Individual participant dataSharing planned: Yes. Anonymous individual participant data for all primary and secondary outcome measures will be made available
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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.
Fabio Esposito, MD principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shifts working hours with different schedules in people with Shift Work Type Circadian Rhythm Sleep Disorder and Chronobiology Disorders, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 18 Jan 2020. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (SE) (time frame: 8 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453398, which also lists 23 linked publications.
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 18 Jan 2020.