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.
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.
None
Parallel
Chronobundle - light
Other interventionBright daytime light from 09:00 to 13:00 starting on day 1. The light will be 10,000 lux at 12" and provide a minimal intensity of 1,250 lux at the angle of the eye (30" to 36" distance). The light has a temperature of 5,000 Kelvin indicating a high blue wavelength content which should maximize circadian effects (validated device Sunbox Lighting, Maryland). Following the 09:00 to 13:00 bright light, the room lights will remain on and the curtains will remain open to maximize daytime light exposure while not decreasing bright light tolerance.
chronobundle - feeding
Other interventionFor patients receiving enteral feeds, time-restricted (daytime) intermittent feeding will include 4 meals delivered at 08:00, 12:00, 16:00 and 20:00. Each meal will include one-fourth of the recommended daily tube feed volume.
chronobundle - mobility
Other interventionWhile in the MICU, exercise/mobility sessions led by physical therapy or occupational therapy providers will occur twice daily between 09:00 and 16:00 (i.e., one additional session beyond usual care); intensity will be determined by clinical status and documented in the chart by our physical therapy service. Patients in other hospital locations (e.g., general medical ward post-MICU discharge) will receive one additional session beyond usual care via a study staff-led exercise/mobility session; intensity will be determined by clinical status.
chronobundle - sleep
Other interventionOvernight sleep promotion will occur between 22:00 and 06:00 with a more restricted sleep period between 00:00 and 04:00. This will be achieved by rescheduling non-urgent care. There will be no changes to urgent care. Additionally, room lights will be dimmed, curtains drawn, and room doors closed. Television screens will be fitted with blue light-blocking filters.
Circadian alignment based on diurnal heart rate variation
Individual heart rate nadir compared to population normal nadir of 04:00. Maximum difference +/- 12 hours.
Urine 6-sulfatoxymelatonin acrophase change from normal
Individual urine 6-sulfatoxymelatonin acrophase compared to population normal acrophase of 03:30. Maximum difference +/- 12 hours. Urine 6-sulfatoxymelatonin measures will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Urine 6-sulfatoxymelatonin acrophase absolute time
Clock time of individual urine 6-sulfatoxymelatonin acrophase. Urine 6-sulfatoxymelatonin measures will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Urine 6-sulfatoxymelatonin acrophase change from day 1 to day 4
Change in individual urine 6-sulfatoxymelatonin acrophase between day 1 observation and day 4 observation period (after 72 hours intervention). Urine 6-sulfatoxymelatonin measures will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Overnight sleep duration
Minutes of sleep from 22:00 to 05:59 as measured by NoxA1 portable polysomnography (PSG) device.
Exploratory - Days without Delirium or Coma
Days alive and without delirium or coma out of the 14 days post randomization
Exploratory - Ventilator Free Days
Days alive and ventilator free out of 28 days post-randomization.
Exploratory - Time to ICU Discharge
Days to ICU discharge post-randomization.
Exploratory - Time to Hospital Discharge
Days to hospital discharge post-randomization.
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
