NIH-funded research R01 grant

Reestablishing sleep and clock alignment in critically ill patients with a sleep–clock bundle

Official title: Reestablishing Sleep and Circadian Alignment in Medically Critically Ill Patients via a Mechanistic Randomized Controlled Trial of an ICU Sleep Chronobundle (ReAlign-ICU)

Funded at Yale University · NIH-11420590 · Data updated 2026-11-12

A study tests a sleep and circadian rhythm bundle in ICU patients to help restore healthy sleep patterns and bodily rhythms.

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Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionYale University
NIH-funded
Lab location1 site (New Haven, United States)
Project startJuly 21, 2023
Project endJune 30, 2028
Funding year2026
Award (this year)$778,389
NIH project number5R01HL163659-04
Project IDNIH-11420590 on NIH RePORTER

Who could benefit from this research

Could help

Adults in the ICU with acute critical illness who are experiencing sleep and circadian disruption.

Less likely to help

Critically ill patients without sleep/circadian disruption or those for whom the intervention is contraindicated may not benefit.

What this research studies

In this trial, critically ill adults in the ICU receive a combined sleep and circadian promotion strategy designed to realign their internal clocks with real-world time. The approach targets multiple sleep domains and circadian signals to improve sleep quality, metabolism, immune function, and overall recovery. Researchers will monitor sleep patterns, circadian markers, and clinical outcomes to see if the bundle leads to better ICU recovery compared with standard care.

Why it matters

Potential benefit: If successful, the bundle could improve sleep, organ function, and recovery for ICU patients.

How similar studies have gone: Previous ICU sleep bundles improved sleep but often did not address circadian alignment, making this approach novel but grounded in prior findings.

Where this research is happening

  • Yale University
    New Haven, United States
    Active

Researchers

  • Principal investigator: Knauert, Melissa P — Yale University
  • Study coordinator: Knauert, Melissa P

Related research

Other NIH-funded projects on the same topics.

  • Restoring sleep and body‑clock timing for ICU patients

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    NIH research Weill Medical Coll of Cornell Univ · New York, United States · NIH-11019746

  • Improving sleep and circadian rhythms in critically ill patients in the ICU

    This study is testing a new way to help patients in the ICU get better sleep and feel more in sync with day and night, which could improve their health while they recover.

    NIH research Yale University · New Haven, United States · NIH-10892022

  • Cognitive behavioral therapy and trazodone for insomnia phenotypes with high blood pressure

    A clinical study tests how CBT-I and the sleep drug trazodone work for adults with insomnia and high blood pressure, focusing on a specific sleep duration pattern.

    NIH research Pennsylvania State Univ Hershey Med Ctr · Hershey, United States · NIH-11635771

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  • Short Course vs Standard Course Antifungal Therapy for Pediatric Candidemia

    This study tests whether a shorter 7-day total antifungal treatment after an initial 7 days of echinocandin therapy is as effective as the usual 14-day course for children with candidemia.

    NIH research Arkansas Children's Hospital Res Inst · Little Rock, United States · NIH-11606535

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.