Exploring sleep and circadian rhythm disorders in ICU patients
Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU: An Observational Study
This study looks at how common sleep problems are for adults in the ICU and what factors might be making their sleep worse, to help find ways to improve their rest and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06346613 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prevalence and contributing factors of sleep and circadian rhythm disorders (SCD) among patients in the Intensive Care Unit (ICU). It aims to understand how various stressors in the ICU environment, such as noise and lack of natural light, disrupt normal sleep patterns and circadian rhythms. By identifying the incidence and characteristics of SCD, the study seeks to inform the development of targeted interventions to improve patient outcomes. The research will involve adult patients who have been in the ICU for over 12 hours and includes monitoring their sleep-wake cycles and other physiological indicators.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients over 18 years old who have been transferred to the ICU during daytime hours and have stayed for more than 12 hours.
Not a fit: Patients with acute brain injuries, cognitive impairments, or those in critical conditions such as hemodialysis or ECMO therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and overall health outcomes for ICU patients.
How similar studies have performed: While there has been limited progress on understanding SCD in ICUs, this study aims to fill a significant gap in knowledge, suggesting a novel approach to addressing this issue.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- 180 Fenglin Road — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Tingyu Guan, B.N.
- Email: 22111170002@m.fudan.edu.cn
- Phone: +86 19921875401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.