Restoring sleep and body‑clock timing for ICU patients
Reestablishing Sleep and Circadian Alignment in Medically Critically Ill Patients via a Mechanistic Randomized Controlled Trial of an ICU Sleep Chronobundle (ReAlign-ICU)
['FUNDING_R01'] · YALE UNIVERSITY · NIH-11176008
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
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | YALE UNIVERSITY (nih funded) |
| Locations | 1 site (NEW HAVEN, UNITED STATES) |
| Trial ID | NIH-11176008 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: 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.
Not a fit: 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.
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 performed: 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
NEW HAVEN, UNITED STATES
- YALE UNIVERSITY — NEW HAVEN, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: KNAUERT, MELISSA P — YALE UNIVERSITY
- Study coordinator: KNAUERT, MELISSA P
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 below.