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Sleep Chronobundle for Circadian Rhythm Disorder (ReAlign-ICU Trial)
N/A
Recruiting
Led By Melissa P Knauert, MD, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and post-treatment, 72 hours
Awards & highlights
ReAlign-ICU Trial Summary
This trial will test if a sleep and circadian treatment bundle can improve sleep quality and metabolism by normalizing the body's clocks.
Who is the study for?
This trial is for adult patients recently admitted to the MICU who are intubated and not expected to be extubated within 24 hours. It's not suitable for those with severe brain injuries, circadian disorders, recent shift work, homelessness, high risk of aspiration or hypoglycemia issues.Check my eligibility
What is being tested?
The study tests a 'chronobundle' approach in ICU patients to align sleep and eating patterns with natural body clock rhythms. The goal is to see if this improves sleep quality and metabolic function by promoting normal circadian alignment.See study design
What are the potential side effects?
Since the interventions involve non-invasive methods like controlled light exposure, scheduled feeding times, mobility exercises, and sleep promotion techniques rather than medications, side effects are minimal but may include discomfort from schedule adjustments.
ReAlign-ICU Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
ReAlign-ICU Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-treatment, 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment, 72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Circadian alignment change from normal
Secondary outcome measures
Atypical sleep
Biologic night NREM3 proportion
Biologic night REM proportion
+15 moreOther outcome measures
Exploratory - Days without Delirium or Coma
Exploratory - Mortality
Exploratory - Time to Hospital Discharge
+2 moreReAlign-ICU Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ChronobundleExperimental Treatment4 Interventions
The chronobundle will include bright daytime light, time-restricted intermittent feeding, enhanced exercise/mobility, and overnight sleep promotion.
Group II: ControlActive Control1 Intervention
Usual ICU care.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,053 Total Patients Enrolled
1 Trials studying Critical Illness
650 Patients Enrolled for Critical Illness
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,697 Total Patients Enrolled
18 Trials studying Critical Illness
20,973 Patients Enrolled for Critical Illness
Melissa P Knauert, MD, PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at high risk for low blood sugar episodes.You have a high chance of having existing sleep pattern issues due to severe brain injury, circadian disorder, recent shift work, homelessness, being in jail, or living in an institution.I am on a breathing machine and haven't passed a breathing test.You are not expected to produce more than 250 milliliters of urine in a day.I have had low blood sugar episodes without fully recovering neurologically.I am at high risk of choking due to a problem with my digestive system.I am 18 years old or older.You were recently hospitalized for taking too much medication or are going through serious alcohol withdrawal.Patients admitted to the intensive care unit within 24 hours of 9:00 on the day of enrollment.I was admitted to the ICU for severe diabetes complications.I do not have low hemoglobin, heart issues, active bleeding, or recent blood transfusion.You are in a very critical condition and receiving end-of-life care.
Research Study Groups:
This trial has the following groups:- Group 1: Chronobundle
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this experiment open to applicants at present?
"As confirmed by records on clinicaltrials.gov, the indicated trial is no longer recruiting individuals for participation; though it was initially placed online April 1st 2023 and last updated September 19th 2022. Fortunately, there are currently 382 other trials actively seeking patients to partake in their research endeavors."
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