Critical Illness Clinical Trial
Official title:
Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU: An Observational Study
NCT number | NCT06346613 |
Other study ID # | B2024-076R |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 7, 2024 |
Est. completion date | December 31, 2025 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | 180 Fenglin Road | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
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. |
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