- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06346613
Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU
Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU: An Observational Study
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tingyu Guan, B.N.
- Phone Number: +86 19921875401
- Email: 22111170002@m.fudan.edu.cn
Study Locations
-
-
-
Shanghai, China, 20032
- Recruiting
- 180 Fenglin Road
-
Contact:
- Shining Cai, MSc
- Phone Number: 2724 86-021-64041990
- Email: cai.shining@zs-hospital.sh.cn
-
Principal Investigator:
- Yuxia Zhang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overnight sleep duration
Time Frame: During the first three nights after entering the ICU.
|
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.
|
Wake after sleep onset(WASO)
Time Frame: During the first three nights after entering the ICU.
|
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.
|
Overnight Rapid Eye Movement (REM) proportion
Time Frame: During the first three nights after entering the ICU.
|
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.
|
Overnight non-rapid eye movement stage 1 (NREM1) proportion
Time Frame: During the first three nights after entering the ICU.
|
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.
|
Overnight non-rapid eye movement stage 2 (NREM2) proportion
Time Frame: During the first three nights after entering the ICU.
|
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.
|
Overnight non-rapid eye movement stage 3 (NREM3) proportion
Time Frame: During the first three nights after entering the ICU.
|
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.
|
Sleep period time ratio (sleep continuity)
Time Frame: During the first three nights after entering the ICU.
|
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.
|
Subject sleep quality
Time Frame: Within 12 hours after each PSG measurement
|
Using the Richards-Campbell Sleep Questionnaire to measure the sleep quality of patients.
|
Within 12 hours after each PSG measurement
|
Activity counts
Time Frame: Starting from 22:00 on the first day after admission to the ICU, continuing for three days.
|
The activity count is recorded by actigraphy.
|
Starting from 22:00 on the first day after admission to the ICU, continuing for three days.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: YuXia Zhang, PhD, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2024-076R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Illness
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Boston Children's HospitalCompleted
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Sándor BeniczkyUniversity of Aarhus; Danish Council for Independent Research; Søster og Verner...CompletedCritical Illness Myopathy | Myopathy Critical IllnessDenmark
-
Hospital de Clinicas de Porto AlegreUnknownCritical Illness PolyneuropathiesBrazil
-
Peking Union Medical College HospitalBaxter Healthcare CorporationUnknownNutrition Therapy for Critical Illness
-
Assistance Publique - Hôpitaux de ParisRecruitingCritical Illness Related Corticosteroids InsufficiencyFrance
-
Yuzuncu Yıl UniversityKahramanmaras Sutcu Imam University; Izmir Ataturk Training and Research HospitalCompleted