Actively Recruiting
Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle
Led by Yale University · Updated on 2025-11-05
160
Participants Needed
2
Research Sites
215 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Critically ill patients admitted to the MICU requiring mechanical ventilation, noninvasive ventilation, high flow nasal cannula, or vasopressor support, remaining on qualifying support at 9:00 AM on randomization day
- Randomization occurs on the second or third calendar day after MICU admission
- MICU admission must be within 24 hours of hospital admission
- Age 18 years or older
You will not qualify if you...
- Not expected to stay in the MICU for at least 48 hours after randomization
- Imminently dying or under hospice care
- Significant risk of pre-existing circadian abnormalities including severe chronic brain injury, acute brain injury impacting circadian clock, documented circadian disorder or blindness, recent shift work within last year, or homelessness/incarceration/institutionalization
- High risk of aspiration or already on enteral nutrition before ICU admission
- ICU admission for diabetic ketoacidosis or hyperosmolar state
- History of hypoglycemia without full neurological recovery
- History of high risk for hypoglycemia such as insulin-secreting tumors or recurrent hypoglycemia
- ICU admission due to suicide attempt complications
- ICU admission due to acute drug overdose or active alcohol withdrawal
- Positive test for SARS-CoV
- Patients with diseases requiring high-level biological sample precautions (e.g., HIV, West Nile virus, Monkeypox, TB) are excluded from urine sample collection
- Patients leaving MICU within 24 hours of randomization are excluded from further study activities
- Patients leaving MICU between 24 and 48 hours post-randomization continue activities but are excluded from primary analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
M
Melissa P Knauert, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here