Study of a Sleep Chronobundle for Critically Ill Patients

This study is looking at a new approach called a "sleep chronobundle" to help critically ill patients in the Medical Intensive Care Unit (MICU) improve their sleep and body clock alignment. The chronobundle includes bright daytime light, timed meals, extra mobility sessions, and efforts to promote sleep overnight by rescheduling non-urgent care and dimming lights. The study aims to see if this bundle can help align your body's natural rhythms and improve sleep and metabolism. You might be able to join if you are an adult MICU patient needing breathing support or medication to maintain blood pressure. The study hopes to enroll 160 patients, but its current status is unclear.

Study design
This is an interventional study planning to enroll 160 participants. It will test a "sleep chronobundle" intervention.
What's involved
Participants will receive bright daytime light, timed meals, extra mobility sessions, and overnight sleep promotion. These interventions will start on day 1 and continue throughout your MICU stay.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured 72 hours after the treatment ends.

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NCT05551325

Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle

Recruiting
NAAges 18+InterventionalTreatment
Yale University
~160 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Chronobundle - lightchronobundle - feedingchronobundle - mobilitychronobundle - sleep

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Circadian alignment based on diurnal heart rate variation
Measured over post-treatment, 72 hours
Critical Illness
Sleep Deprivation
Circadian Rhythm Sleep Disorder, Unspecified
2 sites across 1 states
Connecticut2
  • Melissa P Knauert, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

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  • Circadian alignment based on diurnal heart rate variationpost-treatment, 72 hours

    Individual heart rate nadir compared to population normal nadir of 04:00. Maximum difference +/- 12 hours.