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NCT05551325 | Recruiting | Critical Illness


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

Yale University

Brief Summary:

More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.

Condition or disease

Critical Illness

Sleep Deprivation

Circadian Rhythm Sleep Disorder, Unspecified

Intervention/treatment

Chronobundle - light

chronobundle - feeding

chronobundle - mobility

chronobundle - sleep

Phase

Not Applicable

Detailed Description:

An evidence-based treatment that simultaneously addresses intensive care unit (ICU) sleep and circadian disruption (SCD) is desperately needed. Such treatment is needed because patients admitted to the ICU are at high risk for adverse outcomes resulting directly from acute SCD. It is well established among healthy controls that acute SCD is associated with immediate negative consequences such as metabolic, cognitive, cardiovascular, respiratory, skeletal muscle, and immune dysfunction. Normalization of sleep and circadian processes improves these dysfunctions. In the ICU, sleep and circadian processes cannot be segregated, and there are likely several overlapping domains of SCD (e.g., sleep duration, timing, architecture, and continuity, and circadian alignment and amplitude). Thus, a bundled approach to sleep and circadian promotion holds the most promise for reversing SCD, normalizing broader physiologic disruptions, and improving ICU outcomes. To date, ICU sleep promotion bundles have had limited success in documenting improved sleep, and sleep bundles have commonly ignored circadian disruption and circadian-based sleep promotion strategies. This is a critical gap. Translation of circadian principles to ICU sleep promotion is essential because alignment between biologic and clock time allows for subsequent strategic scheduling of behaviors, for example, scheduling sleep promotion during the biologic night to improve sleep duration and quality. In addition, circadian alignment has broader physiologic implications and related potential to improve function across a wide variety of organ systems, for example, scheduling eating during the biologic day to improve glucose tolerance. Investigations to date have not tested the effect of a multifaceted intervention that includes promotion of both circadian alignment via photic and nonphotic zeitgebers and overnight sleep via non-pharmacologic strategies (sleep chronobundle). The overall objective of this project is to test whether a sleep chronobundle, including daytime bright light, time-restricted daytime feeding, increased daytime mobility, and overnight sleep promotion mitigates ICU SCD. A mechanistic randomized controlled trial will be used to test our central hypotheses that a sleep chronobundle will (1) align biologic and clock day-night; (2) overlap behaviors (e.g., sleeping and eating) correctly with biologic time periods; and therefore (3) improve sleep and metabolic processes in the ICU. The focus of this study is on sleep and glucose metabolism metrics because of their high relevance to critical illness.}}

Study Type : Interventional
Estimated Enrollment : 160 participants
Masking : Single
Masking Description : Due to the nature of the intervention participants, care providers, and investigators will be able to ascertain group assignment. Primary and secondary outcome assessors of urine 6-sulfatoxymelatonin levels, sleep scoring, and glucose levels via continuous glucose monitoring will be masked from group assignment. Exploratory outcome assessors will be able to ascertain group assignment as they will be at the patient's bedside or in the medical record during the process of recording outcomes.
Primary Purpose : Treatment
Official Title : Reestablishing Sleep and Circadian Alignment in Medically Critically Ill Patients Via a Mechanistic Randomized Controlled Trial (RCT) of an Intensive Care Unit (ICU) Sleep Chronobundle
Actual Study Start Date : April 8, 2024
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027
Arm Intervention/treatment

No Intervention: Control

Usual ICU care.

Other: Chronobundle - light

Other: chronobundle - feeding

Experimental: Chronobundle

The chronobundle will include bright daytime light, time-restricted intermittent feeding, enhanced exercise/mobility, and overnight sleep promotion.

Other: chronobundle - mobility

Other: chronobundle - sleep

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion
  • MICU patients admitted within 24 hours as of 09:00 on day of enrollment (study day 1).
  • Intubated and not having passed a spontaneous breathing trial or expected to be extubated in the next 24 hours as of enrollment.
  • Age greater than or equal to 18 years old.
  • Exclusion
    • Not expected to make >250 mL urine per 24 hours.
    • 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 (injury less than 30 days ago including acute intracranial bleed, traumatic brain injury, central nervous system infection, tumor); (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.
    • Have a past medical history or positive test on admission for any known disease or illness that would categorize biological samples as biosafety level 3 (BSL3) or higher.
    • For the Oral glucose tolerance testing sub-study, we will EXCLUDE PATIENTS meeting the following criteria
      • Hemoglobin less than 10.0 grams per deciliter.
      • Active cardiac ischemia.
      • Active significant bleed (decrease in hemoglobin of more than 2.0 grams per deciliter in 24 hours).
      • Receipt of a blood transfusion during the current hospital admission.

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

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

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Locations


Recruiting

United States, Connecticut

Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus

New Haven, Connecticut, United States, 06520

Recruiting

United States, Connecticut

Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street

New Haven, Connecticut, United States, 06520

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