An interventional study of Nighttime noise & light reduction and Clustering patient-care interactions in Sleep Deprivation, Critical Illness and Sleep-Wake Disorders, sponsored by University of California, San Diego. Not yet recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Health services research
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.
DESIGN SHANTI-ICU is a pragmatic, hybrid type I effectiveness-implementation study using a concurrent multiple-intervention stepped wedge randomized design. The unit of randomization is the hospital, not the individual patient. Eight hospitals, i.e. "clusters" with two ICUs per hospital, will be randomized to Bundle A or Bundle B, and to the time at which they cross over from usual care.
All clusters begin in a usual care preparation period consisting of 9 to 18 months, cross over in one of 4 steps with 3 months between each step, and remain in the implementation period consisting of 24 to 33 months. An evaluation phase follows implementation.
SETTING AND POPULATION Participating hospitals span academic, community, safety-net, and resource-limited settings. Based on historical census at the participating hospitals, approximately 62,500 adult ICU admissions are anticipated across the preparation and implementation phases.
INTERVENTIONS Bundle A is an evidence-based, multicomponent, non-pharmacologic sleep promotion strategy. Bundle A includes reducing nighttime noise and light, clustering patient care interactions, offering non-pharmacologic sleep aids such as earplugs and eye masks, and promoting daytime wakefulness through light exposure and out-of-bed activity.
Bundle B includes Bundle A plus pharmacist-led pharmacologic strategies. These include deprescribing medications known to disrupt sleep, optimizing the timing of medication administration, and selective use of sleep-promoting agents (e.g., melatonin, dexmedetomidine).
ANALYSIS Analyses will compare patient-level delirium incidence and secondary outcomes before and after bundle implementation, and between Bundle A and Bundle B, using regression models appropriate to a stepped wedge design which account for clustering of patients within the hospital and ICU. Pre-specified subgroups include age, race and ethnicity, and ICU type.
IMPLEMENTATION EVALUATION Bundle A and B implementation will be evaluated continuously. The investigators will assess how consistently each bundle is delivered, what helps and what gets in the way of adoption at the bedside, and whether the bundles are sustained over time. Evaluation will draw on sources such as bundle checklist data, interviews with clinicians and stakeholders, and site process observations, and will be guided by established implementation science frameworks such as the Consolidated Framework for Implementation Research (CFIR) and RE-AIM.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
This study's planned enrollment of 62,500 is above the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Nighttime noise & light reduction · Behavioral: Clustering patient-care interactions · Behavioral: Non-pharmacologic sleep aids · Behavioral: Daytime light exposure · Behavioral: Encourage out-of-bed activity
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
Behavioral: Nighttime noise & light reduction · Behavioral: Clustering patient-care interactions · Behavioral: Non-pharmacologic sleep aids · Behavioral: Daytime light exposure · Behavioral: Encourage out-of-bed activity · Other: Medication management to support nighttime sleep
Nighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist.
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.
Also known as: Cluster care
Offering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist.
Promote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist.
Promote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist.
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.
Delirium incidence
Indicator that a patient screens positive on the Confusion Assessment Method for the ICU (CAM-ICU) at any point during their ICU stay. CAM-ICU is performed by ICU nursing staff as part of usual clinical care and abstracted from the health record.
Time frame: From ICU admission until first positive CAM-ICU, ICU discharge, or death, whichever comes first, an expected average of 5 days
Delirium duration (delirium/coma-free days)
Number of days from ICU admission to day 7 on which the patient is alive, CAM-ICU negative, and not in coma. Days alive following ICU discharge are counted as delirium and coma free.
Time frame: From ICU admission through ICU day 7, ICU discharge, or death, whichever comes first
ICU sleep quality (Richards-Campbell Sleep Questionnaire)
Patient-reported rating of the previous night's sleep using the Richards-Campbell Sleep Questionnaire (RCSQ). The Richards-Campbell Sleep Questionnaire is a six-item visual analog scale along 100mm lines, the first five items relating to sleep quality and an optional sixth item relating to ICU noise. Each item is scored 0 to 100 and the first five of the items are averaged for a total score ranging from 0 to 100. Higher scores indicate better sleep quality. The Richards-Campbell Sleep Questionnaire is not completed for patients comatose overnight. Proxy completion by nursing staff is recorded and identified as such.
Time frame: Collected up to 7 times per week in the morning (rating the prior night's sleep), from ICU day 2 through ICU discharge or death, an expected average of 5 days
Overall ICU sleep quality (Sleep in the ICU Questionnaire)
One-time patient-reported rating of sleep quality across the entire ICU stay using the Sleep in the ICU Questionnaire (SICUQ), administered after ICU downgrade and before hospital discharge. The Sleep in the Intensive Care Unit Questionnaire uses items rated on a 1 to 10 numeric scale. For sleep quality items, higher scores indicate better sleep quality. For sleep disruption items, higher scores indicate more sleep disruption.
Time frame: Once, within 48 hours after ICU discharge and before hospital discharge, an expected average of 10 days after ICU admission
ICU Length of Stay
Length of stay in the ICU, calculated from the times of ICU arrival and ICU downgrade or death.
Time frame: From the time of ICU admission to the time of ICU discharge or death, an expected average of 5 days
Caregiver-reported sleep quality
Exploratory caregiver-reported measures using a modified Numeric Rating Scale for Sleep (NRS-Sleep). The Numeric Rating Scale for Sleep is a single-item rating of sleep quality on a scale of 0 to 10, with higher scores indicating better sleep quality.
Time frame: Once, before hospital discharge, an expected average of 10 days after ICU admission
Caregiver sleep experience
Exploratory caregiver-reported sleep experience using a modified Daily Use Caregiver Sleep Survey (DUCSS). The Daily Use Caregiver Sleep Survey mixes numerical responses with ordinal scales. Numerical items include questions such as asking for the time the participant went to bed and the number of hours of sleep. Other questions are scored on ordinal scales of 1-2, 1-3, and 1-5, with higher scores indicating lower sleep quality or higher sleep impairment.
Time frame: Once, before hospital discharge, an expected average of 10 days after ICU admission
Family satisfaction with ICU care
Exploratory family-reported satisfaction using a modified Family Satisfaction with Care in the Intensive Care Unit questionnaire (FS-ICU-24R). A family member rates their satisfaction with the patient's care in the ICU. Five-point Likert scale responses are transformed to a 0 to 100 percentage scale, with higher scores indicating greater satisfaction.
Time frame: Once, before hospital discharge, an expected average of 10 days after ICU admission
Plan to share: Yes — As a condition of the PCORI award, a de-identified full data package will be deposited into the PCORI Data Repository (PCODR) at the Inter-university Consortium for Political and Social Research (ICPSR) as a controlled-access dataset following study closeout.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Following study closeout, per PCORI award terms
Access criteria: Controlled access via the PCORI Data Repository at ICPSR, subject to that repository's data use terms
Data sharing details ↗ · www.pcori.org
Start is estimated for Oct 2026; primary completion for Apr 2030, 42 months later.
Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 42 months is above that.
Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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