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Circadian Rhythm and Delirium in ICU

The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05342987
Enrollment
190
Registered
2022-04-25
Start date
2022-02-15
Completion date
2023-07-31
Last updated
2025-05-11

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

Conditions

Circadian Rhythm, Intensive Care Unit Delirium, Sleep Quality

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.

Interventions

None listed

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of melatonin levelThree time a day in 3, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICUTest Serum melatonin level
Sleep Qualityup to 14 days after admission in ICUInvestigators screen sleep quality by Richards-Campbell Sleep Questionnaire
Changes of cortisol levelThree time a day in 0, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICUTest Serum cortisol level

Secondary

MeasureTime frameDescription
ICU deliriumup to 14 days after admission in ICUInvestigators screen delirium by CAM-ICU twice a day, each time during day and night
patient outcomeup to 14 days after admission in ICUMortality in ICU
LOSup to 14 days after admission in ICUlength of ICU stay

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026