Circadian Rhythm and Delirium in ICU

The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit

The study aims to investigate the status of circadian rhythm and sleep quality in ICU patients and their influence factors. And explore the pathway of circadian rhythm on ICU delirium.

The hypothesis of study is that icu patients experience circadian and sleep rhythm disorder, especially in patient who have delirium.

Study Overview

• Status: Completed
• Conditions: Sleep Quality; Circadian Rhythm; Intensive Care Unit Delirium

Detailed Description

Delirium is an acute and fluctuating alteration of mental state characterized by a disturbance in attention, level of consciousness and cognition. At present, there is no unified conclusion on the pathogenesis of delirium. There are many different hypotheses, such as the neuroinflammation hypothesis, the neuronal aging hypothesis, the oxidative stress hypothesis, the neurotransmitter hypothesis, the neuroendocrine hypothesis and the circadian rhythm disturbance hypothesis. Among them, the circadian rhythm disturbance hypothesis believes that the circadian rhythm disorder caused by various reasons, which leads to sleep disturbance and melatonin secretion disorder promotes the occurrence of acute cognitive impairment, which in turn leads to the occurrence of delirium. Circadian rhythm refers to the rhythm of any biological process in the human body that repeats and maintains within 24 hours without external stimulation. By far, the most common way to measure circadian rhythm is through vital signs rhythms, hormone secretion (cortisol and melatonin levels), and sleep-wake cycle.

Due to the special environment and treatment needs in ICU make patients' circadian rhythm easily broken, and produced a large latent harm to patients. Most studies are in the process of delirium and sleep research, selecting a small subgroup to evaluate the circadian rhythm indicators of patients, and the overall relationship between delirium and circadian rhythm is not clear.

Thus, the study aims to investigate the status of circadian rhythm and sleep quality in ICU patients and their influence factors, and explore the pathway of circadian rhythm action on ICU delirium.

• Study Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Shanghai Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged above 18 who are admitted to ICU will be screened for eligibility.

Description

Inclusion Criteria:

• Aged above 18
• RASS>-4

Exclusion Criteria:

• History of mental or psychological illness
• The patient remained in coma or deep sedation
• Delirium was occurring at the time of admission
• Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
• Neurosurgery and maternal patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of melatonin level	Test Serum melatonin level	Three time a day in 3, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU
Sleep Quality	Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire	up to 14 days after admission in ICU
Changes of cortisol level	Test Serum cortisol level	Three time a day in 0, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU delirium	Investigators screen delirium by CAM-ICU twice a day, each time during day and night	up to 14 days after admission in ICU
patient outcome	Mortality in ICU	up to 14 days after admission in ICU
LOS	length of ICU stay	up to 14 days after admission in ICU

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2021ZSYQ17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No