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NCT Number: NCT05342987

Circadian Rhythm and Delirium in ICU

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.

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Key information

Conditions

Circadian Rhythm Dyssomnias Intensive Care Unit Delirium Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes of melatonin level

    Time frame: 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

  2. Sleep Quality

    Time frame: up to 14 days after admission in ICU

    Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire

  3. Changes of cortisol level

    Time frame: 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 outcomes

  1. ICU delirium

    Time frame: up to 14 days after admission in ICU

    Investigators screen delirium by CAM-ICU twice a day, each time during day and night

  2. patient outcome

    Time frame: up to 14 days after admission in ICU

    Mortality in ICU

  3. LOS

    Time frame: up to 14 days after admission in ICU

    length of ICU stay

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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