Circadian Rhythm and Delirium in ICU

Completed

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

• Registration Number: NCT05342987
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2022-02-15
• Status Verified: 2022-03
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-25
• Primary Completion: 2023-02-01
• Study Completion: 2023-07-31
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of 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	Test Serum melatonin level
Sleep Quality	up to 14 days after admission in ICU	Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire
Changes of 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	Test Serum cortisol level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China