Viewing Study NCT06346613



Ignite Creation Date: 2024-05-06 @ 8:20 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06346613
Status: RECRUITING
Last Update Posted: 2024-04-04
First Post: 2024-03-14

Brief Title: Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU
Sponsor: Shanghai Zhongshan Hospital
Organization: Shanghai Zhongshan Hospital

Study Overview

Official Title: Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU An Observational Study
Status: RECRUITING
Status Verified Date: 2024-03
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: None
Brief Summary: Most ICU patients experience sleep and circadian disruption SCD which causes a profound negative impact on patients such as prolonged mechanical ventilation glucose intolerance and the occurrence of delirium In order to better promote the alignment of circadian rhythm in ICU patients this project will explore the prevalence of SCD and a series of influencing factors contributing to SCD in ICU patients to help construct targeted intervention programs in the future
Detailed Description: The circadian rhythm refers to the oscillation phenomenon of physiological biochemical and behavioral life phenomena of organisms with a 24-hour cycle The circadian rhythm affects multiple physiological indicators such as the sleep-wake cycle hormone levels heart rate blood pressure and metabolic functions Maintaining a normal circadian rhythm is crucial for human health However a series of stressful stressors in the ICU such as lack of normal light-dark cycle changes high levels of noise make sleep and circadian rhythm disruptionSCD common and severe and such disruption will have serious negative impacts on patients clinical outcomes Therefore there is an urgent need for effective interventions to assist ICU patients in promoting their sleep and circadian rhythms The first step in intervention is to understand the current incidence and characteristics of ICU SCD as well as the factors contributing to such disruption

To date there has been limited progress on the current status of SCD prevalence in ICUs On one hand there may be significant variability in ICU SCD between individual patients and subgroups On the other hand this variability may change over time as patients recover from acute illnesses This heterogeneity from population and time impedes the development of interventions for SCD Therefore there is an urgent need to understand the characteristics trends of SCD in different patients and the factors influencing these changes

The overall objective of this project is to explore the status and influencing factors of ICU patients sleep and circadian rhythms in the first 3 days by conducting a longitudinal study using multiple objective subjective indicators aiming to more accurately and objectively evaluate the changes in patients circadian rhythms

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