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

NCT06346613 | Recruiting

• 1 other identifier: B2024-076R
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Deprivation; Circadian Rhythm Disorders; Critical Illness

Keywords

circadian rhythm; sleep; ICU

Outcome Measures

Primary Outcomes (1)

• Rhythmicity of melatonin levels.

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

  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)

• Overnight sleep duration

  During the first three nights after entering the ICU.

• Wake after sleep onset(WASO)

  During the first three nights after entering the ICU.

• Overnight Rapid Eye Movement (REM) proportion

  During the first three nights after entering the ICU.

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

  During the first three nights after entering the ICU.

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

  During the first three nights after entering the ICU.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, 20032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40037668 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 ml of the patient's blood was drawn and centrifuged to obtain serum, which was used to measure the patient's melatonin levels

MeSH Terms

Conditions

Sleep Deprivation; Chronobiology Disorders; Critical Illness

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• YuXia Zhang, PhD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Tingyu Guan, B.N.

CONTACT

+86 19921875401; 22111170002@m.fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 4, 2024
• Study Start: March 7, 2024
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)