Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775731
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-15
First Post:
2023-02-21
Brief Title:
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Changes in Markers of Inflammation and of the Pro-thrombotic State Induced by Altered Sleep in Hospital Shift and Day Workers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPNO
Brief Summary:
The goal of this observational study is to learn if acutely andor chronically altered sleep induces inflammation andor 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 andor to suggest a condition of generalized inflammation and a tendency to form clots Relevant information on health status is also collected for each participant
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None