The SLEEP-CARE Study

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06336408

Enrollment

Registered

2024-03-28

Start date

2024-02-01

Completion date

2025-12-31

Last updated

2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disturbance

Keywords

Polysomnography, intensive care unit

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
LOS	Through study completion, an average of 10 days	length of ICU stay

Countries

China

Contacts

Primary ContactJingjing Li, Master

li.jingjing@zs-hospital.sh.cn13512106878

Outcome results