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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus
RECRUITING
New Haven
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street
RECRUITING
New Haven
Contact Information
Primary
Melissa P Knauert, MD, PhD
melissa.knauert@yale.edu
203-785-4163
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2028-06-29
Participants
Target number of participants: 160
Treatments
No_intervention: Control
Usual ICU care.
Experimental: Chronobundle
The chronobundle will include bright daytime light, time-restricted intermittent feeding, enhanced exercise/mobility, and overnight sleep promotion.
Sponsors
Leads: Yale University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov