Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers (IPNO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Sleep Disorder; Hemostatic Disorder; Shift-Work Related Sleep Disturbance
• Intervention / Treatment: Diagnostic test: Tests for markers of inflammation and activated hemostasis

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20138
    • Recruiting
    • Centro Cardiologico Monzino
    • Contact: Elena M Faioni, MD; Phone Number: 2136 ++39 02 5800; Email: elena.faioni@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Hospital workers who volunteer for the study

Description

Inclusion Criteria:

• Hospital worker who either works in shifts including night shifts, or only during the day

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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]	Diagnostic test: Tests for markers of inflammation and activated hemostasis; 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; Other Names: Questionnaires; Pittsburgh Sleep Quality Index, General Anxiety Disorder-7
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)	Diagnostic test: Tests for markers of inflammation and activated hemostasis; 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; Other Names: Questionnaires; Pittsburgh Sleep Quality Index, General Anxiety Disorder-7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep disorder	Evaluation of altered sleep (chronic or acute) through PSQI questionnaire	measurement relates to previous three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Investigators: Principal Investigator: Elena M Faioni, MD, Centro Cardiologico Monzino

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: sleep; inflammation; hemostasis; shift-work
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Inflammation; Sleep Wake Disorders; Coagulants; Hemostatics
• Other Study ID Numbers: CCM 1788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No