Circadian RhythmNCT05342987
Circadian Rhythm and Delirium in ICU
An observational study of Circadian Rhythm and Sleep Quality, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circadian Rhythm, Sleep Quality, Intensive Care Unit Delirium
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged above 18 who are admitted to ICU will be screened for eligibility.
Who may be able to join
- Aged above 18
- RASS>-4
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit
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.
Read the 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.
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of melatonin level
Test Serum melatonin level
Measured: Three time a day in 3, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU
Sleep Quality
Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire
Measured: up to 14 days after admission in ICU
Changes of cortisol level
Test Serum cortisol level
Measured: Three time a day in 0, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU
Secondary outcomes (3)
ICU delirium
Investigators screen delirium by CAM-ICU twice a day, each time during day and night
Measured: up to 14 days after admission in ICU
patient outcome
Mortality in ICU
Measured: up to 14 days after admission in ICU
LOS
length of ICU stay
Measured: up to 14 days after admission in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Feb 2022
- Primary completion1 Feb 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342987
- Sponsor's protocol ID
- 2021ZSYQ17
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37312021
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05342987
- Acronym / sponsor ID
- 2021ZSYQ17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged above 18 who are admitted to ICU will be screened for eligibility.
Key inclusion criteria (2 listed)
- Aged above 18
- RASS>-4
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Sleep Quality
Time frame: up to 14 days after admission in ICU
Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire
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
3 secondary outcomes
ICU delirium
Time frame: up to 14 days after admission in ICU
patient outcome
Time frame: up to 14 days after admission in ICU
LOS
Time frame: up to 14 days after admission in ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 37312021Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm and Sleep Quality, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.