Chronobundle for Critical Illness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street, New Haven, CT
Critical Illness+5 More
chronobundle - sleep - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Circadian Rhythm Sleep Disorder, Unspecified
  • Critical Illness
  • Sleep Debt

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Critical Illness

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: Day 1 and post-treatment, 72 hours

Day 1
Change in Circadian alignment from day 1 to day 3
post-treatment, 72 hours
Atypical sleep
Biologic night NREM3 proportion
Biologic night REM proportion
Biologic night arousal index (continuity)
Biologic night sleep duration
Circadian alignment absolute time
Circadian alignment based on diurnal heart rate variation
Circadian alignment change from normal
Daytime NREM3 proportion
Daytime REM proportion
Daytime arousal index (continuity)
Daytime sleep duration
Glucose tolerance
Matsuda's Index
Overnight Rapid Eye Movement (REM) proportion
Overnight arousal index (continuity)
Overnight non-rapid eye movement stage 3 (NREM3) proportion
Overnight sleep duration

Trial Safety

Safety Progress

1 of 3

Other trials for Critical Illness

Trial Design

2 Treatment Groups

Control
1 of 2
Chronobundle
1 of 2
Active Control
Experimental Treatment

160 Total Participants · 2 Treatment Groups

Primary Treatment: Chronobundle · No Placebo Group · N/A

ChronobundleExperimental Group · 4 Interventions: chronobundle - sleep, chronobundle - feeding, chronobundle - mobility, Chronobundle - light · Intervention Types: Other, Other, Other, Other
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and post-treatment, 72 hours
Closest Location: Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street · New Haven, CT
Photo of New Haven  1Photo of New Haven  2Photo of New Haven  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Critical Illness
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for the study if you are at least 18 years old.
You are admitted to the MICU within 24 hours of enrollment.
You are intubated and not expected to be extubated in the next 24 hours.
You have a structural or functional abnormality of the gastrointestinal tract.
You are admitted due to an acute drug overdose or active alcohol withdrawal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.