An observational study in Sleep Disturbance, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Shanghai Zhongshan Hospital · Observational
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.
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's planned enrollment of 80 is below the median of 126 across 63 observational studies indexed under Dyssomnias.
Browse Dyssomnias studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ICU patients
Exclusion Criteria:
Compound outcome index
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.
Time frame: Discharge from ICU or 2 weeks
LOS
length of ICU stay
Time frame: Through study completion, an average of 10 days
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Shanghai Zhongshan Hospital