Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle (NCT05551325)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
- Chronobundle - light (OTHER)
- chronobundle - feeding (OTHER)
- chronobundle - mobility (OTHER)
- chronobundle - sleep (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus — New Haven, Connecticut
- Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street — New Haven, Connecticut
📞 Contact the Study Coordinator
Phone: (203) 785-4163
Email: melissa.knauert@yale.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.