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Clinical Trials/NCT06336408
NCT06336408
Recruiting
Not Applicable

Explore the Effects of SLEEP Deprivation on Short-term Outcomes in ICU pAtients basEd on polysomnogRaphy:a Single-center Prospective Cohort Study

Shanghai Zhongshan Hospital1 site in 1 country80 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disturbance
Sponsor
Shanghai Zhongshan Hospital
Enrollment
80
Locations
1
Primary Endpoint
Compound outcome index
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Sleep disorder is common in ICU patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. In 2023, American Thoracic Society released a research statement on sleep and circadian disruption(SCD) in ICU, which considered SCD is an important potential target for improving critical illness outcomes. Although polysomnography(PSG) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in ICU. This makes the sleep quality of ICU patients overestimated and difficult to reflect their true sleep conditions. And the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • adults (≥ 18-years old)
  • anticipated SICU stay for 24 hours or more

Exclusion Criteria

  • pregnancy
  • Have a clear history of medication for sleep disorders
  • History of mental or psychological illness
  • Treated with CRRT or ECMO during monitoring

Outcomes

Primary Outcomes

Compound outcome index

Time Frame: Discharge from ICU or 2 weeks

Patients with cognitive, respiratory, digestive, cardiovascular, or immune-related adverse outcomes. Cognitive-related adverse outcomes were defined as delirium in the ICU(using Confusion Assessment Method Intensive Care Unit to screen delirium as negative or positive). Respiratory-related adverse outcomes was defined as a decrease in blood gas oxygenation index below 300mmHg in ICU. Gastrointestinal related adverse prognosis was defined as bleeding from stress ulcer in ICU. Cardiovascular-related adverse outcomes were defined as newly diagnosed heart failure, arrhythmia, and myocardial infarction in ICU. Immune-related poor prognosis defined SOFA (Sequential Organ Failure Assessment) scores increased by more than 2 points compared to the time of entry.

Secondary Outcomes

  • LOS(Through study completion, an average of 10 days)

Study Sites (1)

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