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Sleep DeprivationNCT06346613

Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU

An observational study of Sleep Deprivation and Circadian Rhythm Disorders, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Most ICU patients experience sleep and circadian disruption (SCD), which causes a profound negative impact on patients, such as prolonged mechanical ventilation, glucose intolerance, and the occurrence of delirium. Read more about this study

Who is it for?
Ages 18 years and older
How many people
56 participants
Where
1 siteChina
Study dates
7 Mar 2024to 31 Dec 2025
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: In the Surgical Intensive Care Unit (SICU) at Zhongshan Hospital, Fudan University, critically ill adult patients from both surgical and medical specialties are admitted in SICU.

Who may be able to join

  • Adult patients older than 18 years old.
  • Patients transferred to ICU during the time period of 8:00-22:00.
  • Stay in the ICU for more than 12 hours and at least one overnight period.
  • Patients or their family members are informed and consent to participate in the research.

Who cannot join

  • Acute brain injuries within 30 days, such as acute intracranial bleeding, traumatic brain injury, central nervous system infection, or chronic brain injuries lasting over 30 days with an inability to live independently.
  • Previously diagnosed with mild cognitive impairment or Alzheimer's disease.
  • Patients affected by blindness or optic nerve disorder.
  • Patients who are pregnant or breastfeeding.
  • Patient in prone position, hemodialysis, or ECMO therapy during PSG monitoring
  • Imminently dying or with a hospice status.

Trial locations and contacts

1 site in 1 country.

Tingyu Guan, B.N. contact

+86 19921875401

22111170002@m.fudan.edu.cn

China1 site, 1 recruiting

  • 180 Fenglin Road

    Shanghai, 20032

    Shining Cai, MSc, 86-021-64041990 ext. 2724, cai.shining@zs-hospital.sh.cn

    Yuxia Zhang, PhD

    Recruiting

Other trials in China

About this study

Official title: Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU: An Observational Study

Most ICU patients experience sleep and circadian disruption (SCD), which causes a profound negative impact on patients, such as prolonged mechanical ventilation, glucose intolerance, and the occurrence of delirium. In order to better promote the alignment of circadian rhythm in ICU patients, this project will explore the prevalence of SCD and a series of influencing factors contributing to SCD in ICU patients, to help construct targeted intervention programs in the future.

Read the detailed description

The circadian rhythm refers to the oscillation phenomenon of physiological, biochemical, and behavioral life phenomena of organisms with a 24-hour cycle. The circadian rhythm affects multiple physiological indicators, such as the sleep-wake cycle, hormone levels, heart rate, blood pressure, and metabolic functions. Maintaining a normal circadian rhythm is crucial for human health. However, a series of stressful stressors in the ICU, such as lack of normal light-dark cycle changes, high levels of noise, make sleep and circadian rhythm disruption(SCD) common and severe, and such disruption will have serious negative impacts on patients' clinical outcomes. Therefore, there is an urgent need for effective interventions to assist ICU patients in promoting their sleep and circadian rhythms. The first step in intervention is to understand the current incidence and characteristics of ICU SCD, as well as the factors contributing to such disruption.

To date, there has been limited progress on the current status of SCD prevalence in ICUs. On one hand, there may be significant variability in ICU SCD between individual patients and subgroups, On the other hand, this variability may change over time as patients recover from acute illnesses. This heterogeneity from population and time impedes the development of interventions for SCD. Therefore, there is an urgent need to understand the characteristics, trends of SCD in different patients and the factors influencing these changes.

The overall objective of this project is to explore the status and influencing factors of ICU patients' sleep and circadian rhythms in the first 3 days by conducting a longitudinal study using multiple objective subjective indicators, aiming to more accurately and objectively evaluate the changes in patients' circadian rhythms.

Keywords
circadian rhythm, sleep, ICU
Medical subject headings
Sleep Deprivation, Chronobiology Disorders, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rhythmicity of melatonin levels.

    Measuring the patient's circadian rhythm using their melatonin secretion levels.

    Measured: Starting from 3:00 on the first day after admission to the ICU, four blood samples are taken every day (at 3:00, 9:00, 15:00, and 21:00), continuing for three days.

Secondary outcomes (9)

  1. Overnight sleep duration

    Minutes of sleep from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)

    Measured: During the first three nights after entering the ICU.

  2. Wake after sleep onset(WASO)

    Minutes of WASO from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)

    Measured: During the first three nights after entering the ICU.

  3. Overnight Rapid Eye Movement (REM) proportion

    Proportion of Stage REM sleep from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)

    Measured: During the first three nights after entering the ICU.

  4. Overnight non-rapid eye movement stage 1 (NREM1) proportion

    Proportion of Stage NREM1 sleep from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)

    Measured: During the first three nights after entering the ICU.

  5. Overnight non-rapid eye movement stage 2 (NREM2) proportion

    Proportion of Stage NREM2 sleep from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)

    Measured: During the first three nights after entering the ICU.

  6. Overnight non-rapid eye movement stage 3 (NREM3) proportion

    Proportion of Stage NREM3 sleep from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)

    Measured: During the first three nights after entering the ICU.

  7. Sleep period time ratio (sleep continuity)

    Nighttime sleep duration divided by the number of nighttime sleep cycles, sleep data is measured by portable polysomnography device (Alice PDX) from 22:00 to 6:00.

    Measured: During the first three nights after entering the ICU.

  8. Subject sleep quality

    Using the Richards-Campbell Sleep Questionnaire to measure the sleep quality of patients.

    Measured: Within 12 hours after each PSG measurement

  9. Activity counts

    The activity count is recorded by actigraphy.

    Measured: Starting from 22:00 on the first day after admission to the ICU, continuing for three days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start7 Mar 2024
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06346613
Sponsor's protocol ID
B2024-076R
Status last verified
Mar 2024
First submitted
14 Mar 2024
Last updated
4 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guan T, Li J, Hou J, Zhu A, Chen X, Pan W, Liu X, Latour JM, Cai S, Zhang Y. Sleep pattern and perceived sleep quality of patients in the intensive care unit: An exploratory observational study. Aust Crit Care. 2026 Aug;39(4):101633. doi: 10.1016/j.aucc.2026.101633. Epub 2026 Jun 19.

    PubMed 42320370

  • Guan T, Li J, Hou J, Pan W, Liu X, Cai S, Zhang Y. Prospective cohort study on characteristics, associated factors and short-term prognosis of sleep and circadian rhythm in intensive care unit: protocol for the SYNC study. BMJ Open. 2025 Mar 4;15(3):e091184. doi: 10.1136/bmjopen-2024-091184.

    PubMed 40037668

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Deprivation and Circadian Rhythm Disorders, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Apr 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tingyu Guan, B.N. (+86 19921875401, 22111170002@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhythmicity of melatonin levels. (time frame: Starting from 3:00 on the first day after admission to the ICU, four blood samples are taken every day (at 3:00, 9:00, 15:00, and 21:00), continuing for three days.). 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 NCT06346613, which also lists 2 linked publications.

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 4 Apr 2024.

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