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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346613
• Other study ID #: B2024-076R
• Status: Recruiting
• Start date: March 7, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Tingyu Guan, B.N.
• Phone: +86 19921875401
• Email: 22111170002[@]m.fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients older than 18 years old.

2. Patients transferred to ICU during the time period of 8:00-22:00.

3. Stay in the ICU for more than 12 hours and at least one overnight period.

4. Patients or their family members are informed and consent to participate in the research.

Exclusion Criteria:

1. 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.

2. Previously diagnosed with mild cognitive impairment or Alzheimer's disease.

3. Patients affected by blindness or optic nerve disorder.

4. Patients who are pregnant or breastfeeding.

5. Patient in prone position, hemodialysis, or ECMO therapy during PSG monitoring

6. Imminently dying or with a hospice status.

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Critical Illness
• Sleep Deprivation

Locations

Country	Name	City	State
China	180 Fenglin Road	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	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	Overnight sleep duration	Minutes of sleep from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)	During the first three nights after entering the ICU.
Secondary	Wake after sleep onset(WASO)	Minutes of WASO from 22:00 to 6:00 as measured by portable polysomnography device (Alice PDX)	During the first three nights after entering the ICU.
Secondary	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)	During the first three nights after entering the ICU.
Secondary	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)	During the first three nights after entering the ICU.
Secondary	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)	During the first three nights after entering the ICU.
Secondary	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)	During the first three nights after entering the ICU.
Secondary	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.	During the first three nights after entering the ICU.
Secondary	Subject sleep quality	Using the Richards-Campbell Sleep Questionnaire to measure the sleep quality of patients.	Within 12 hours after each PSG measurement
Secondary	Activity counts	The activity count is recorded by actigraphy.	Starting from 22:00 on the first day after admission to the ICU, continuing for three days.