Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05775731 |
| Other study ID # |
CCM 1788 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 27, 2022 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Centro Cardiologico Monzino |
| Contact |
Elena M Faioni, MD |
| Phone |
++39 02 5800 |
| Email |
elena.faioni[@]cardiologicomonzino.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
