Circadian Rhythm and Delirium in ICU

Sleep Quality Clinical Trial

Official title:

The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342987
• Other study ID #: 2021ZSYQ17
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Jingjing Li
• Phone: 13512106878
• Email: li.jingjing[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm
• Delirium
• Intensive Care Unit Delirium
• Sleep Quality

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Sleep Quality	Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire	up to 14 days after admission in ICU
Primary	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	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
Secondary	patient outcome	Mortality in ICU	up to 14 days after admission in ICU
Secondary	LOS	length of ICU stay	up to 14 days after admission in ICU