What side effects are associated with this type of intervention?

Common treatments for critical illness that aim to improve sleep and circadian alignment include the use of melatonin, melatonin receptor agonists, and non-pharmacological interventions like earplugs, eye masks, and light therapy. Known side effects of melatonin and its agonists can include daytime drowsiness, dizziness, and headaches. Non-pharmacological interventions generally have minimal side effects, though some patients may experience discomfort or irritation from earplugs and eye masks. Light therapy can sometimes cause eye strain or headaches.

What prior FDA approvals exist?

The FDA has approved various treatments for critical illnesses, but specific approvals for therapies aimed at normalizing circadian alignment to improve sleep and metabolism are limited. Melatonin and melatonin receptor agonists, such as ramelteon, have been studied for their potential benefits in improving sleep and circadian rhythms in critically ill patients. However, their use in intensive care units is still under investigation, and more clinical trials are needed to establish their efficacy and safety in this context.

What other types of research exist?

Promising alternatives to the Sleep Chronobundle for critical illness patients include: 1) Timed light therapy, which involves exposure to bright light at specific times to reset circadian rhythms. 2) Melatonin supplementation, which can help regulate sleep-wake cycles and improve sleep quality. 3) Intermittent feeding aligned with circadian rhythms, which may enhance metabolic function and recovery. These interventions leverage the principles of chronotherapy to optimize treatment outcomes.

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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

Must not have

Having a history suggesting an abnormally high risk of suffering hypoglycemia

Having a history of hypoglycemia without documented full neurological recovery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment, 72 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a 'sleep chronobundle' to help ICU patients by improving their sleep and aligning their body clocks. The treatment includes daytime light exposure, timed eating, increased daytime activity, and better nighttime sleep. It aims to enhance sleep quality and metabolic health.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am at high risk for low blood sugar episodes.

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I have had low blood sugar episodes without fully recovering neurologically.

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I am at high risk of choking due to a problem with my digestive system.

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I was admitted to the ICU for severe diabetes complications.

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I do not have low hemoglobin, heart issues, active bleeding, or recent blood transfusion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and post-treatment, 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and post-treatment, 72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and post-treatment, 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Circadian alignment based on diurnal heart rate variation

Secondary study objectives

Atypical sleep

Biologic night NREM3 proportion

Biologic night REM proportion

+14 more

Other study objectives

Exploratory - Days without Delirium or Coma

Exploratory - Mortality

Exploratory - Time to Hospital Discharge

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for critical illness that focus on normalizing circadian alignment and improving sleep and metabolism include light therapy, scheduled feeding, and sleep-promoting medications. These interventions work by aligning the body's internal clock with natural day-night cycles, which can enhance sleep quality and improve metabolic function. This is particularly important for critical illness patients as disrupted circadian rhythms and poor sleep can worsen metabolic dysfunction, immune response, and overall recovery, potentially reducing the duration of mechanical ventilation and ICU stay.

Holistic Needs Assessment of Cancer Survivors-Supporting the Process Through Digital Monitoring of Circadian Physiology.Intermittent feeding and circadian rhythm in critical illness.Influence of the Circadian System on Disease Severity.