Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03684460
Eligibility Criteria:
Inclusion Criteria:
1. Hospital admission ≤30 hours at noon on enrollment day
2. Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment
3. Age ≥50 years
Exclusion Criteria:
1. At significant risk for pre-existing circadian abnormalities:
* Severe chronic brain injury (Injury greater than 30 days ago resulting in the inability to live independently)
* Acute brain injury of any severity (Injury less than 30 days ago including acute intracranial bleed, traumatic brain injury, central nervous system infection, tumor)
* Documented circadian disorder or blind/disease of the optic nerve
* Current history of substance abuse including alcohol (use in last 30 days)
3\. Transferred from an outside hospital. 4. History of bipolar disease 5. Paralyzed (due to injury, disease or medications)
Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded; patients transferred from the MICU to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03684460
Study Brief:
Protocol Section:
NCT03684460