Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle

Launched by YALE UNIVERSITY · Sep 19, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on helping patients in the Medical Intensive Care Unit (MICU) who are struggling with sleep and body clock issues due to their critical illness. Many patients in the MICU experience significant sleep disruptions, which can affect their overall health. The trial is testing a special program called a "sleep chronobundle," which includes strategies to improve sleep and align the body’s natural rhythms (circadian rhythms). By participating, patients may have the chance to improve their sleep quality and metabolic health.

To be eligible for this study, patients need to be at least 18 years old and admitted to the MICU within 24 hours. They should be intubated (on a ventilator) but not expected to be taken off it within the next day. However, there are some important exclusions: patients with serious brain injuries, certain medical conditions, or those who have recently experienced significant health crises may not be able to participate. If eligible, participants can expect to receive tailored support aimed at improving their sleep and aligning their daily routines with their body's needs. It’s important to note that this study is actively recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion:
• • Critically ill patients admitted to the MICU who require mechanical ventilation, noninvasive ventilation, high flow nasal cannula, or vasopressor support and who remain on qualifying support as of 09:00 on study randomization day. Randomization will occur on the second or third calendar day following MICU admission. MICU admission must have occurred within 24 hours of hospital admission.
• • Age greater than or equal to 18 years old.
• Exclusion:
• • Not expected to remain in the MICU for at least 48 hours post-randomization.
• • Imminently dying or with a hospice status.
• • At significant risk for pre-existing circadian abnormalities including: (1) severe chronic brain injury (injury greater than 30 days ago resulting in the inability to live independently); (2) acute brain injury of any severity that is reasonably expected to impact the central circadian clock (e.g., cardiac arrest); (3) documented circadian disorder (\<1% population) or blind/disease of the optic nerve; (4) current or recent (last 1 year) shiftwork; and (5) homelessness, incarceration, or institutionalization.
• • At elevated risk of aspiration due to structural or functional abnormality of the gastrointestinal tract OR fed via enteral nutrition (e.g., "tube feeds") prior to ICU admission.
• • Admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state; this diagnosis will be established via review of the medical record for a description of diabetes in the past medical history or the presence of diabetes medication on the confirmed home medication list AND hyperglycemia attributed to diabetic ketoacidosis or diabetic hyperosmolar state by the admitting care team in their written assessment of the patient.
• • Having a history of hypoglycemia without documented full neurological recovery; this diagnosis will be established via review of the patient's past medical history in the medical record;
• • Having a history suggesting an abnormally high risk of suffering hypoglycemia (e.g., known insulin secreting tumor, history of unexplained or recurrent hypoglycemia or fulminant hepatic failure); this diagnosis will be established via review of the patient's past medical history in the medical record.
• • Admitted due to complications of a suicide attempt.
• • Admitted due to an acute drug overdose or active alcohol withdrawal.
• • Positive for SARS-CoV.
• • Urine 6-sulfatoxymelatonin measures will be considered for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points. However, we will exclude patients from urine measures if they have a history or positive test for any known disease or illness that would categorize biological samples as BSL3 or higher. This includes HIV, West Nile virus, Monkeypox, and Mycobacterium tuberculosis (TB).
• • Note: Patients who leave the MICU within 24 hours of randomization are excluded from further study activities. Patients who leave the MICU between 24 and 48 hours post-randomization continue all study activities but will not be included in the primary analysis. Patients who remain in the MICU for at least 48 hours post-randomization will continue all study activities and be included in the primary analysis.