Shift-Work Related Sleep DisturbanceIPNONCT05775731
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
An observational study of Shift-Work Related Sleep Disturbance and Inflammation, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
The goal of this observational study is to learn if acutely and/or chronically altered sleep induces inflammation and/or a pro-thrombotic state (a tendency to form clots) in hospital workers who either work in shifts or are exclusively daily workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Related Sleep Disturbance, Inflammation, Hemostatic Disorder
- What is being tested?
- Tests for markers of inflammation and activated hemostasis
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2022to 30 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital workers who volunteer for the study
Who may be able to join
- Hospital worker who either works in shifts including night shifts, or only during the day
Who cannot join
- Known sleep disorder diagnosed by polysomnography and/or nocturnal saturation study
- Sleep apnea-hypopnea syndrome in C-PAP (Continuous Positive Airway Pressure) treatment
- Chronic treatment with sleep-inducers
- Chronic heart failure class NYHA III and IV
- Ischemic heart disease
- Venous thromboembolism
- Chronic anticoagulant and/or anti-platelet therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Markers of Inflammation and of the Pro-thrombotic State Induced by Altered Sleep in Hospital Shift and Day Workers
The goal of this observational study is to learn if acutely and/or chronically altered sleep induces inflammation and/or a pro-thrombotic state (a tendency to form clots) in hospital workers who either work in shifts or are exclusively daily workers. The main questions it aims to answer are:
- Does chronically altered sleep induce a pro-inflammatory and pro-thrombotic state, which are steps towards cardiovascular disease, knowing that is associated with poor sleep?
- Does acutely disrupted sleep, such as that observed in night shift workers, induce a pro-inflammatory and pro-thrombotic state in otherwise healthy subjects? Participants in the study are hospital workers who either work in shifts, including night shifts, or only during the day. Sleep quality is assessed by a validated questionnaire (the Pittsburgh Sleep Quality Index). Markers of inflammation and of the pro-thrombotic state are measured at baseline and, if appropriate, after the night shift. These are markers of platelet activation, D-dimer, Interleukin-6 and endothelin 1, known to contribute and/or to suggest a condition of generalized inflammation and a tendency to form clots. Relevant information on health status is also collected for each participant.
Read the detailed description
Impaired sleep (quantity and quality) is associated with a number of chronic diseases, including an increased risk of cardiovascular events. Some forms of sleep impairment such as insomnia are very frequent and can be easily identified through dedicated and validated questionnaires. The pathway through which impaired sleep heightens cardiovascular risk is not known. Some limited studies suggest activation of coagulation could follow chronic sleep impairment. Atherosclerotic plaque formation is associated with the activation of coagulation, and with chronic inflammation. It would be interesting to know if chronic or acute sleep impairment, such as that experienced by night-shift hospital workers, could induce an inflammatory and pro-thrombotic state either acutely or chronically.
To test whether these hypotheses are correct, volunteer hospital workers who either work in shifts or do not will be enrolled, to test activation of inflammation and hemostasis through established markers (platelet, inflammation and coagulation activation markers). Shift workers will be analyzed before and after a night shift.
Data on anxiety and general health (chronic disorders, medications) as well as on sleep, through validated questionnaires, will be also collected.
Two groups: night-shift workers and daily workers will be compared. Comparisons will be carried out also within night-shift workers, at baseline and after a nigh shift. Finally, subjects who sleep well and who do not sleep well will be compared, independently of shift work.
The investigators believe that if it is shown that insomnia, a frequent and often not addressed sleep disturbance, is associated with a pro-inflammatory and pro-thrombotic state in otherwise healthy workers, this finding would have important consequences, first of all in designing prospective studies on the development of cardiovascular disease in altered sleep and its prevention.
- Being tested
- Tests for markers of inflammation and activated hemostasis
- Keywords
- sleep, hemostasis, inflammation, shift-work
- Medical subject headings
- Inflammation, Hemostatic Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests for markers of inflammation and activated hemostasisDiagnostic test
Also called Questionnaires, Pittsburgh Sleep Quality Index, General Anxiety Disorder-7
Volunteers who do not have exclusion criteria, are invited to complete the three questionnaires and to choose a date for blood drawing based on whether they are shift workers or not. Blood is immediately processed for platelet markers, and stored for inflammation and coagulation markers
| Study group | Role | What they receive |
|---|---|---|
| shift worker | - shift worker: works at least 60 nights per year Each subject will have blood taken twice (before and after the night-shift), and will answer three questionnaires [Pittsburgh Sleep Quality Index, Generalized Anxiety Disorder-7 (GAD-7) for anxiety disorder and a general health questionnaire] Receives: Diagnostic Test: Tests for markers of inflammation and activated hemostasis | |
| daily worker | - daily worker: does not work at night (from 8 pm to 6 am) Each subject will have blood taken once, and will answer three questionnaires (Pittsburgh Sleep Quality Index, GAD-7 for anxiety disorder and a general health questionnaire) Receives: Diagnostic Test: Tests for markers of inflammation and activated hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disorder
Evaluation of altered sleep (chronic or acute) through PSQI questionnaire
Measured: measurement relates to previous three months
Secondary outcomes (1)
Activation of inflammation and/or hemostasis
altered markers of inflammation and hemostasis in shift workers. The markers considered are Endothelin 1, D-dimer, IL-6, complete platelet activation and microvesicle formation
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start27 Sep 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Related Sleep DisturbanceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena M Faioni, MD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775731
- Sponsor's protocol ID
- CCM 1788
- Acronym
- IPNO
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Markers of Inflammation and of the Pro-thrombotic State Induced by Altered Sleep in Hospital Shift and Day Workers
- ClinicalTrials.gov ID
- NCT05775731
- Acronym / sponsor ID
- IPNO / CCM 1788
- Keywords
- sleep, hemostasis, inflammation, shift-work
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Mar 2023 (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.
The goal of this observational study is to learn if acutely and/or chronically altered sleep induces inflammation and/or a pro-thrombotic state (a tendency to form clots) in hospital workers who either work in shifts or are exclusively daily workers. The main questions it aims to answer are:
- Does chronically altered sleep induce a pro-inflammatory and pro-thrombotic state, which are steps towards cardiovascular disease, knowing that is associated with poor sleep?
- Does acutely disrupted sleep, such as that observed in night shift workers, induce a pro-inflammatory and pro-thrombotic state in otherwise healthy subjects? Participants in the study are hospital workers who either work in shifts, including night shifts, or only during the day. Sleep quality is assessed by a validated questionnaire (the Pittsburgh Sleep Quality Index). Markers of inflammation and of the pro-thrombotic state are measured at baseline and, if appropriate, after the night shift. These are markers of platelet activation, D-dimer, Interleukin-6 and endothelin 1, known to contribute and/or to suggest a condition of generalized inflammation and a tendency to form clots. Relevant information on health status is also collected for each participant.
Detailed description
Impaired sleep (quantity and quality) is associated with a number of chronic diseases, including an increased risk of cardiovascular events. Some forms of sleep impairment such as insomnia are very frequent and can be easily identified through dedicated and validated questionnaires. The pathway through which impaired sleep heightens cardiovascular risk is not known. Some limited studies suggest activation of coagulation could follow chronic sleep impairment. Atherosclerotic plaque formation is associated with the activation of coagulation, and with chronic inflammation. It would be interesting to know if chronic or acute sleep impairment, such as that experienced by night-shift hospital workers, could induce an inflammatory and pro-thrombotic state either acutely or chronically.
To test whether these hypotheses are correct, volunteer hospital workers who either work in shifts or do not will be enrolled, to test activation of inflammation and hemostasis through established markers (platelet, inflammation and coagulation activation markers). Shift workers will be analyzed before and after a night shift.
Data on anxiety and general health (chronic disorders, medications) as well as on sleep, through validated questionnaires, will be also collected.
Two groups: night-shift workers and daily workers will be compared. Comparisons will be carried out also within night-shift workers, at baseline and after a nigh shift. Finally, subjects who sleep well and who do not sleep well will be compared, independently of shift work.
The investigators believe that if it is shown that insomnia, a frequent and often not addressed sleep disturbance, is associated with a pro-inflammatory and pro-thrombotic state in otherwise healthy workers, this finding would have important consequences, first of all in designing prospective studies on the development of cardiovascular disease in altered sleep and its prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shift worker | – | Diagnostic Test: Tests for markers of inflammation and activated hemostasis- shift worker: works at least 60 nights per year Each subject will have blood taken twice (before and after the night-shift), and will answer three questionnaires [Pittsburgh Sleep Quality Index, Generalized Anxiety Disorder-7 (GAD-7) for anxiety disorder and a general health questionnaire] |
| daily worker | – | Diagnostic Test: Tests for markers of inflammation and activated hemostasis- daily worker: does not work at night (from 8 pm to 6 am) Each subject will have blood taken once, and will answer three questionnaires (Pittsburgh Sleep Quality Index, GAD-7 for anxiety disorder and a general health questionnaire) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital workers who volunteer for the study
Key inclusion criteria (1 listed)
- Hospital worker who either works in shifts including night shifts, or only during the day
Key exclusion criteria (7 listed)
- Known sleep disorder diagnosed by polysomnography and/or nocturnal saturation study
- Sleep apnea-hypopnea syndrome in C-PAP (Continuous Positive Airway Pressure) treatment
- Chronic treatment with sleep-inducers
- Chronic heart failure class NYHA III and IV
- Ischemic heart disease
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 |
|---|---|---|
| Tests for markers of inflammation and activated hemostasisAlso: Questionnaires, Pittsburgh Sleep Quality Index, General Anxiety Disorder-7Volunteers who do not have exclusion criteria, are invited to complete the three questionnaires and to choose a date for blood drawing based on whether they are shift workers or not. Blood is immediately processed for platelet markers, and stored for inflammation and coagulation markers | Diagnostic test | daily worker, shift worker |
Primary outcome
Sleep disorder
Time frame: measurement relates to previous three months
Evaluation of altered sleep (chronic or acute) through PSQI questionnaire
1 secondary outcome
Activation of inflammation and/or hemostasis
Time frame: through study completion, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Elena M Faioni, MD principal investigator
Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shift-Work Related Sleep Disturbance and Inflammation, run by Centro Cardiologico Monzino 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 7 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. 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?
Results are not available in the source record.
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 disorder (time frame: measurement relates to previous three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2024.