Circadian Rhythm and Delirium in ICU

NCT ID: NCT05342987

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Circadian Rhythm Sleep Quality Intensive Care Unit Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Li J, Cai S, Liu X, Mei J, Pan W, Zhong M, Zhang Y. Circadian rhythm disturbance and delirium in ICU patients: a prospective cohort study. BMC Anesthesiol. 2023 Jun 13;23(1):203. doi: 10.1186/s12871-023-02163-4.

Reference Type DERIVED
PMID: 37312021 (View on PubMed)

Other Identifiers

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2021ZSYQ17

Identifier Type: -

Identifier Source: org_study_id

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