Restoring sleep and body‑clock timing for ICU patients
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-11176008 · Data updated 2026-11-12
This trial will try a combined sleep-and-circadian care program to help people in the intensive care unit sleep better and keep their internal clock on track.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Yale University NIH-funded |
| Lab location | 1 site (New Haven, United States) |
| Project start | July 21, 2023 |
| Project end | June 30, 2028 |
| Funding year | 2025 |
| Award (this year) | $794,275 |
| NIH project number | 5R01HL163659-03 |
| Project ID | NIH-11176008 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults currently admitted to a participating intensive care unit with medical critical illness who can be enrolled under the trial's inclusion criteria are the intended candidates.
✕Less likely to help
People who are not in an ICU, are receiving end‑of‑life comfort care, or have medical conditions that prevent the bundle's interventions may not receive benefit from this trial.
What this research studies
If you or a loved one are in the ICU, this project randomly assigns patients to a bundled program designed to promote both sleep and proper timing of the body's internal clock or to usual care. The bundle uses timed light exposure, scheduling of care and activities, noise and disturbance reduction, and other circadian-friendly routines to encourage sleep at the biologic night. Researchers will measure sleep patterns, clock markers (like melatonin metabolites), and clinical recovery markers to understand how the bundle works. The goal is to link improved sleep and circadian alignment with better organ function, cognition, and recovery after critical illness.
Why it matters
Potential benefit: If successful, the approach could help ICU patients sleep better, realign their internal clocks, and potentially speed recovery and reduce complications.
How similar studies have gone: Prior ICU sleep‑promotion bundles have had limited success, and applying circadian-based timing to sleep promotion is a relatively new and promising approach.
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.
-
Reestablishing sleep and clock alignment in critically ill patients with a sleep–clock bundle
A study tests a sleep and circadian rhythm bundle in ICU patients to help restore healthy sleep patterns and bodily rhythms.
-
Helping family caregivers of critically ill patients make better decisions
This study is all about helping family caregivers of critically ill patients in ICUs, especially those from Black, Indigenous, and People of Color communities, by offering support to ease their emotional stress and help them make tough end-of-life decisions.
-
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.
-
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.
-
Shorter antifungal treatment for kids with candidemia
A multi-center pediatric trial tests whether a shorter, 7 extra days of antifungal therapy after an initial 7 days is just as good as the standard 14-day approach for kids with candidemia who are improving on echinocandin therapy.
-
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.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.