Sleep Promotion Strategies for Critical Illness
(SHANTI-ICU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults.
Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design.
The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality.
Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.
Who Is on the Research Team?
Biren B Kamdar, MD, MBA, MHS
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for adult patients who are admitted to the ICU and receiving routine care. There are no specific individual inclusion or exclusion criteria, as all eligible ICU patients at participating hospitals may receive the sleep improvement interventions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Clustering patient-care interactions
- Daytime light exposure
- Encourage out-of-bed activity
- Medication management to support nighttime sleep
- Nighttime noise & light reduction
- Non-pharmacologic sleep aids
Trial Overview
The study compares two ways to help ICU patients sleep better: one uses non-drug methods like reducing noise and light, clustering care, and encouraging daytime activity; the other adds medication management by a pharmacist. ICUs use one of these bundles as part of standard care.
How Is the Trial Designed?
3
Treatment groups
Active Control
Period prior to cluster crossover. Hospitals/ICUs deliver usual care without a structured sleep promotion bundle. Delirium and sleep outcomes are collected in the same way during this period as during implementation.
Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Johns Hopkins University
Collaborator
Massachusetts General Hospital
Collaborator
University of California, San Francisco
Collaborator
University of Utah
Collaborator
Vanderbilt University Medical Center
Collaborator
University of Puerto Rico
Collaborator
AdventHealth Orlando
Collaborator
Baylor University
Collaborator
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