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

NCT05775731 | Unknown

• 1 other identifier: CCM 1788
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Shift-Work Related Sleep Disturbance; Inflammation; Hemostatic Disorder; Sleep Disorder

Keywords

sleep; hemostasis; inflammation; shift-work

Outcome Measures

Primary Outcomes (1)

• Sleep disorder

  Evaluation of altered sleep (chronic or acute) through PSQI questionnaire

  measurement relates to previous three months

Secondary Outcomes (1)

• Activation of inflammation and/or hemostasis

  through study completion, an average of 8 months

Study Arms (2)

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

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

Interventions

Tests for markers of inflammation and activated hemostasis DIAGNOSTIC_TEST

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

Also known as: Questionnaires, Pittsburgh Sleep Quality Index, General Anxiety Disorder-7

daily worker; shift worker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital workers who volunteer for the study

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead

Study Sites (1)

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma for identification of inflammatory and hemostasis markers

MeSH Terms

Conditions

Inflammation; Hemostatic Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Elena M Faioni, MD

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 20, 2023
• Study Start: September 27, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)