About this trial

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.

Eligibility criteria

Qualifiers

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.

Not expected to remain in the MICU for at least 48 hours post-randomization.

Imminently dying or with a hospice status.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Chronobundle - light
  • chronobundle - feeding
  • chronobundle - mobility
  • chronobundle - sleep

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

2
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus06520, New HavenConnecticut, United States
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street06520, New HavenConnecticut, United States

Sponsors and collaborators

Yale University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator