Sleep Harmonization Via Bundled Team-Based Interventions in the ICU
Key facts
- Who runs it
- University of California, San Diego
- Where
- Boston, Dallas, La Jolla, Nashville, Orlando, Salt Lake City, and San Francisco, United StatesSee the 7 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 62,500 people, planned
- Started
- 1 Oct 2026
- Expected to end
- Mar 2031
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Nighttime noise & light reduction
- Clustering patient-care interactions
- Non-pharmacologic sleep aids
- Daytime light exposure
- Encourage out-of-bed activity
- Medication management to support nighttime sleep
- Record updated
- 25 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Age 18 years or older
- Present in participating ICU
Who cannot take part
- Age less than 18 years
- Present in ICU less than 1 night
Where in United States
Also in 1 other country, 1 site
- Massachusetts General HospitalBoston, United StatesContact: Lorenzo Berra, MDNot yet recruiting
- Baylor University Medical CenterDallas, United StatesContact: Nicole Gorecki, DNPNot yet recruiting
- University of California San Diego HealthLa Jolla, United StatesContact: Biren B Kamdar, MD, MBA, MHSNot yet recruiting
- Vanderbilt University Medical CenterNashville, United StatesContact: E. Wesley Ely, MD, MPHNot yet recruiting
- AdventHealth OrlandoOrlando, United StatesContact: Patricia Louzon, PharmDNot yet recruiting
- University Of Utah HealthSalt Lake City, United StatesContact: Joseph Tonna, MDNot yet recruiting
- University of California San Francisco Medical CenterSan Francisco, United StatesContact: Rima Bouajram, PharmDNot yet recruiting
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- Usual CareNo study treatment, for comparison
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.
- Bundle AExisting treatment, for comparison
Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
Treatment: Nighttime noise & light reduction, Clustering patient-care interactions, Non-pharmacologic sleep aids, Daytime light exposure, and Encourage out-of-bed activity
- Bundle BExisting treatment, for comparison
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
Treatment: Nighttime noise & light reduction, Clustering patient-care interactions, Non-pharmacologic sleep aids, Daytime light exposure, Encourage out-of-bed activity, and Medication management to support nighttime sleep
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults
- Record updated
- 25 September 2026