Sleep Harmonization Via Bundled Team-Based Interventions in the ICU

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07840560
Status
Not Yet Recruiting

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Conditions

  • Bundle Care
  • Critical Illness
  • Delirium
  • Implementation Science
  • Sleep Deprivation
  • Sleep-Wake Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nighttime noise & light reduction — BEHAVIORAL
    Nighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist.
  • Clustering patient-care interactions — BEHAVIORAL
    Clustering patient-care interactions when possible, to reduce the number of times the patient is awakened during the night. Prompted by a single-page bedside checklist.
  • Non-pharmacologic sleep aids — BEHAVIORAL
    Offering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist.
  • Daytime light exposure — BEHAVIORAL
    Promote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist.
  • Encourage out-of-bed activity — BEHAVIORAL
    Promote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist.
  • Medication management to support nighttime sleep — OTHER
    Pharmacist conducts a medication review and makes recommendations related to deprescribing of medications known to disrupt sleep, optimization of medication administration timing, and selective use of sleep-promoting agents such as melatonin and dexmedetomidine when clinically appropriate. No specific medications will be given to all patients, only those recommended by the pharmacist to support sleep for that specific patient after careful review.

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Apr 30, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
62,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual Care
    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.
  • Active Comparator: Bundle A
    Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
  • Active Comparator: Bundle B
    All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.

Primary Outcome Measure

Delirium incidence [ Time Frame: From ICU admission until first positive CAM-ICU, ICU discharge, or death, whichever comes first, an expected average of 5 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California San Diego HealthLa JollaCalifornia92093
Biren B Kamdar, MD, MBA, MHS
[email protected]
818-465-8475
Janelle M Fine, BS
[email protected]
858-534-8199
Biren B Kamdar, MD, MBA, MHS (PRINCIPAL_INVESTIGATOR)
University of California San Francisco Medical CenterSan FranciscoCalifornia94143
Rima Bouajram, PharmD
[email protected]
415-476-1000
Rima Bouajram, PharmD (PRINCIPAL_INVESTIGATOR)
AdventHealth OrlandoOrlandoFlorida32803
Patricia Louzon, PharmD
[email protected]
407-303-5600
Patricia Louzon, PharmD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Lorenzo Berra, MD
[email protected]
617-278-1000
Lorenzo Berra, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
E. Wesley Ely, MD, MPH
[email protected]
615-322-4967
Makayla Cordoza, PhD, RN
[email protected]
E. Wesley Ely, MD, MPH (PRINCIPAL_INVESTIGATOR)
Baylor University Medical CenterDallasTexas75246
Nicole Gorecki, DNP
[email protected]
214-820-0111
Nicole Gorecki, DNP (PRINCIPAL_INVESTIGATOR)
University of Utah HealthSalt Lake CityUtah84132
Joseph Tonna, MD
[email protected]
801-581-2121
Joseph Tonna, MD (PRINCIPAL_INVESTIGATOR)

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