Sleep Harmonization Via Bundled Team-Based Interventions in the ICU
Public ClinicalTrials.gov record NCT07840560. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07840560
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 62,500 participants
Conditions and interventions
Conditions
Interventions
- Nighttime noise & light reduction Behavioral
- Clustering patient-care interactions Behavioral
- Non-pharmacologic sleep aids Behavioral
- Daytime light exposure Behavioral
- Encourage out-of-bed activity Behavioral
- Medication management to support nighttime sleep Other
Behavioral · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2026
- Primary completion
- Mar 31, 2030
- Completion
- Feb 28, 2031
- Last update posted
- Sep 24, 2026
2026 – 2031
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Health | La Jolla | California | 92093 | — |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| University of Utah Health | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07840560, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2026 · Synced Sep 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07840560 live on ClinicalTrials.gov.