The SLEEP-CARE Study

Recruiting

• Conditions: Sleep Disturbance

• Registration Number: NCT06336408
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-02-01
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compound outcome index	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 Outcome Measures

Name	Time	Method
LOS	Through study completion, an average of 10 days	length of ICU stay

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China