Recruiting

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Mental Disorders+1

+ Nervous System Diseases

+ Sleep Wake Disorders

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2024
See protocol details

Summary

Principal SponsorShanghai Zhongshan Hospital
Study ContactJingjing Li, Master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2024

Actual date on which the first participant was enrolled.

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.

Official TitleExplore the Effects of SLEEP Deprivation on Short-term Outcomes in ICU pAtients basEd on polysomnogRaphy：a Single-center Prospective Cohort Study
NCT06336408
Principal SponsorShanghai Zhongshan Hospital
Study ContactJingjing Li, Master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersNervous System DiseasesSleep Wake DisordersParasomnias

Criteria

2 inclusion criteria required to participate
adults (≥ 18-years old)
anticipated SICU stay for 24 hours or more
4 exclusion criteria prevent from participating
pregnancy
Have a clear history of medication for sleep disorders
History of mental or psychological illness
Treated with CRRT or ECMO during monitoring

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhongshan Hospital, Fudan University

Shanghai, ChinaOpen Zhongshan Hospital, Fudan University in Google Maps
Recruiting
One Study Center