Sleep DeprivationSHANTI-ICUNCT07840560
Sleep Harmonization Via Bundled Team-Based Interventions in the ICU
A study testing Nighttime noise & light reduction, Clustering patient-care interactions and Non-pharmacologic sleep aids in people with Sleep Deprivation and Critical Illness, run by University of California, San Diego at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Deprivation, Critical Illness, Sleep-Wake Disorders
- What is being tested?
- Nighttime noise & light reduction, Clustering patient-care interactions and Non-pharmacologic sleep aids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62,500 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Oct 2026to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Present in participating ICU
Who cannot join
- Age less than 18 years
- Present in ICU less than 1 night
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lorenzo Berra, MD, 617-278-1000, lberra@mgh.harvard.edu
Lorenzo Berra, MD
Baylor University Medical Center
Dallas, Texas, 75246
Nicole Gorecki, DNP, 214-820-0111, nicole_gorecki@baylor.edu
Nicole Gorecki, DNP
University of California San Diego Health
La Jolla, California, 92093
Biren B Kamdar, MD, MBA, MHS, 818-465-8475, bkamdar@health.ucsd.edu
Janelle M Fine, BS, 858-534-8199, jfine@health.ucsd.edu
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
E. Wesley Ely, MD, MPH, 615-322-4967, wes.ely@vumc.org
Makayla Cordoza, PhD, RN, makayla.cordoza@vanderbilt.edu
AdventHealth Orlando
Orlando, Florida, 32803
Patricia Louzon, PharmD, 407-303-5600, Patricia.Louzon@AdventHealth.com
Patricia Louzon, PharmD
University of Utah Health
Salt Lake City, Utah, 84132
Joseph Tonna, MD, 801-581-2121, joseph.tonna@hsc.utah.edu
Joseph Tonna, MD
University of California San Francisco Medical Center
San Francisco, California, 94143
Rima Bouajram, PharmD, 415-476-1000, rima.bouajram@ucsf.edu
Rima Bouajram, PharmD
Puerto Rico1 site
University of Puerto Rico, Medical Sciences Campus
San Juan, 00936
Milagros Figueroa-Ramos, PhD, RN, milagros.figueroa@upr.edu
Milagros Figueroa-Ramos, PhD, RN
About this study
Official title: Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Sleep Deprivation, Critical Illness, Sleep-Wake Disorders, Bundle Care, Implementation Science, Delirium
- Being tested
- Nighttime noise & light reduction, Clustering patient-care interactions, Non-pharmacologic sleep aids, Daytime light exposure, Encourage out-of-bed activity
- Keywords
- intensive care unit, sleep promotion, delirium prevention, stepped wedge pragmatic clinical trial, implementation science, Critical Illness, Critical Care, Patient Care Bundles, Sleep Quality, Pharmacology
- Medical subject headings
- Sleep Deprivation, Critical Illness, Sleep Wake Disorders, Delirium, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nighttime noise & light reductionBehavioural
Nighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist.
Clustering patient-care interactionsBehavioural
Also called Cluster care
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 aidsBehavioural
Offering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist.
Daytime light exposureBehavioural
Promote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist.
Encourage out-of-bed activityBehavioural
Promote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist.
Medication management to support nighttime sleepOther
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 group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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 A | Active comparator | Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care. Receives: 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 |
| Bundle B | Active comparator | All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission until first positive CAM-ICU, ICU discharge, or death, whichever comes first, an expected average of 5 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the time of ICU admission to the time of ICU discharge or death, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Concurrent multiple-intervention stepped wedge cluster randomized design. Eight hospitals, with two ICUs per hospital, are randomized to Bundle A or Bundle B and to the time at which they cross over from usual care. Randomization is at the level of the hospital, not the patient.
- Masking
- None (open label)
- Enrolment
- 62,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Johns Hopkins University, Massachusetts General Hospital, University of California, San Francisco, University of Utah, Vanderbilt University Medical Center, University of Puerto Rico, AdventHealth Orlando, Baylor University
- Responsible party
- Principal investigator, Biren Kamdar, University of California, San Diego
- Investigators
- Biren B Kamdar, MD, MBA, MHS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840560
- Sponsor's protocol ID
- 814952
- Other IDs
- BPS-2025C2-46123, 30446589
- Acronym
- SHANTI-ICU
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Knauert MP, Ayas NT, Bosma KJ, Drouot X, Heavner MS, Owens RL, Watson PL, Wilcox ME, Anderson BJ, Cordoza ML, Devlin JW, Elliott R, Gehlbach BK, Girard TD, Kamdar BB, Korwin AS, Lusczek ER, Parthasarathy S, Spies C, Sunderram J, Telias I, Weinhouse GL, Zee PC. Causes, Consequences, and Treatments of Sleep and Circadian Disruption in the ICU: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Apr 1;207(7):e49-e68. doi: 10.1164/rccm.202301-0184ST.
PubMed 36999950Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Rood P, Frenzel T, Verhage R, Bonn M, van der Hoeven H, Pickkers P, van den Boogaard M. Development and daily use of a numeric rating score to assess sleep quality in ICU patients. J Crit Care. 2019 Aug;52:68-74. doi: 10.1016/j.jcrc.2019.04.009. Epub 2019 Apr 6.
PubMed 30981928Freedman NS, Kotzer N, Schwab RJ. Patient perception of sleep quality and etiology of sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1155-62. doi: 10.1164/ajrccm.159.4.9806141.
PubMed 10194160Andrews JL, Louzon PR, Torres X, Pyles E, Ali MH, Du Y, Devlin JW. Impact of a Pharmacist-Led Intensive Care Unit Sleep Improvement Protocol on Sleep Duration and Quality. Ann Pharmacother. 2021 Jul;55(7):863-869. doi: 10.1177/1060028020973198. Epub 2020 Nov 9.
PubMed 33166192Kamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM.0000000000000610.
PubMed 25230376Kamdar BB, Shah PA, King LM, Kho ME, Zhou X, Colantuoni E, Collop NA, Needham DM. Patient-nurse interrater reliability and agreement of the Richards-Campbell sleep questionnaire. Am J Crit Care. 2012 Jul;21(4):261-9. doi: 10.4037/ajcc2012111.
PubMed 22751369Kamdar BB, Combs MP, Colantuoni E, King LM, Niessen T, Neufeld KJ, Collop NA, Needham DM. The association of sleep quality, delirium, and sedation status with daily participation in physical therapy in the ICU. Crit Care. 2016 Aug 18;19:261. doi: 10.1186/s13054-016-1433-z.
PubMed 27538536Kamdar BB, Yang J, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Brower RG, Collop NA, Needham DM. Developing, implementing, and evaluating a multifaceted quality improvement intervention to promote sleep in an ICU. Am J Med Qual. 2014 Nov-Dec;29(6):546-54. doi: 10.1177/1062860613509684. Epub 2013 Nov 22.
PubMed 24270169Kamdar BB, King LM, Collop NA, Sakamuri S, Colantuoni E, Neufeld KJ, Bienvenu OJ, Rowden AM, Touradji P, Brower RG, Needham DM. The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Crit Care Med. 2013 Mar;41(3):800-9. doi: 10.1097/CCM.0b013e3182746442.
PubMed 23314584Nicolas A, Aizpitarte E, Iruarrizaga A, Vazquez M, Margall A, Asiain C. Perception of night-time sleep by surgical patients in an intensive care unit. Nurs Crit Care. 2008 Jan-Feb;13(1):25-33. doi: 10.1111/j.1478-5153.2007.00255.x.
PubMed 18226052Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PubMed 11227580Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379Cordoza M, Kamdar BB, Gorecki NM, Heavner MS. Promoting Sleep in Acute and Critically Ill Adults: Enhancing Recovery Through Evidence-Based Practices. Crit Care Nurse. 2026 Jun 1;46(3):e1-e9. doi: 10.4037/ccn2026191. No abstract available.
PubMed 42219197Kamdar BB, Needham DM, Collop NA. Sleep deprivation in critical illness: its role in physical and psychological recovery. J Intensive Care Med. 2012 Mar-Apr;27(2):97-111. doi: 10.1177/0885066610394322. Epub 2011 Jan 10.
PubMed 21220271
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT07840560
- Acronym / sponsor ID
- SHANTI-ICU / 814952
- Conditions
- Sleep Deprivation, Critical Illness, Sleep-Wake Disorders, Bundle Care, Implementation Science, Delirium
- Keywords
- intensive care unit, sleep promotion, delirium prevention, stepped wedge pragmatic clinical trial, implementation science, Critical Illness, Critical Care, Patient Care Bundles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62,500 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Johns Hopkins University, Massachusetts General Hospital, University of California, San Francisco, University of Utah, Vanderbilt University Medical Center, University of Puerto Rico, AdventHealth Orlando, Baylor University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Concurrent multiple-intervention stepped wedge cluster randomized design. Eight hospitals, with two ICUs per hospital, are randomized to Bundle A or Bundle B and to the time at which they cross over from usual care. Randomization is at the level of the hospital, not the patient.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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 A | Active comparator | Behavioral: Nighttime noise & light reduction, Behavioral: Clustering patient-care interactions, Behavioral: Non-pharmacologic sleep aids, Behavioral: Daytime light exposure, Behavioral: Encourage out-of-bed activityMulticomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care. |
| Bundle B | Active comparator | 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 sleepAll components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Present in participating ICU
Key exclusion criteria (2 listed)
- Age less than 18 years
- Present in ICU less than 1 night
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nighttime noise & light reductionNighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist. | Behavioural | Bundle A, Bundle B |
| Clustering patient-care interactionsAlso: Cluster careClustering 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. | Behavioural | Bundle A, Bundle B |
| Non-pharmacologic sleep aidsOffering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist. | Behavioural | Bundle A, Bundle B |
| Daytime light exposurePromote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist. | Behavioural | Bundle A, Bundle B |
| Encourage out-of-bed activityPromote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist. | Behavioural | Bundle A, Bundle B |
| Medication management to support nighttime sleepPharmacist 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. | Other | Bundle B |
Primary outcome
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
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.
4 secondary outcomes
Delirium duration (delirium/coma-free days)
Time frame: From ICU admission through ICU day 7, ICU discharge, or death, whichever comes first
ICU sleep quality (Richards-Campbell Sleep Questionnaire)
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)
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
Time frame: From the time of ICU admission to the time of ICU discharge or death, an expected average of 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 36999950Knauert MP, Ayas NT, Bosma KJ, Drouot X, Heavner MS, Owens RL, Watson PL, Wilcox ME, Anderson BJ, Cordoza ML, Devlin JW, Elliott R, Gehlbach BK, Girard TD, Kamdar BB, Korwin AS, Lusczek ER, Parthasarathy S, Spies C, Sunderram J, Telias I, Weinhouse GL, Zee PC. Causes, Consequences, and Treatments of Sleep and Circadian Disruption in the ICU: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Apr 1;207(7):e49-e68. doi: 10.1164/rccm.202301-0184ST.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 30981928Rood P, Frenzel T, Verhage R, Bonn M, van der Hoeven H, Pickkers P, van den Boogaard M. Development and daily use of a numeric rating score to assess sleep quality in ICU patients. J Crit Care. 2019 Aug;52:68-74. doi: 10.1016/j.jcrc.2019.04.009. Epub 2019 Apr 6.
- Background: PubMed 10194160Freedman NS, Kotzer N, Schwab RJ. Patient perception of sleep quality and etiology of sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1155-62. doi: 10.1164/ajrccm.159.4.9806141.
- Background: PubMed 33166192Andrews JL, Louzon PR, Torres X, Pyles E, Ali MH, Du Y, Devlin JW. Impact of a Pharmacist-Led Intensive Care Unit Sleep Improvement Protocol on Sleep Duration and Quality. Ann Pharmacother. 2021 Jul;55(7):863-869. doi: 10.1177/1060028020973198. Epub 2020 Nov 9.
- Background: PubMed 25230376Kamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM.0000000000000610.
- Background: PubMed 22751369Kamdar BB, Shah PA, King LM, Kho ME, Zhou X, Colantuoni E, Collop NA, Needham DM. Patient-nurse interrater reliability and agreement of the Richards-Campbell sleep questionnaire. Am J Crit Care. 2012 Jul;21(4):261-9. doi: 10.4037/ajcc2012111.
- Background: PubMed 27538536Kamdar BB, Combs MP, Colantuoni E, King LM, Niessen T, Neufeld KJ, Collop NA, Needham DM. The association of sleep quality, delirium, and sedation status with daily participation in physical therapy in the ICU. Crit Care. 2016 Aug 18;19:261. doi: 10.1186/s13054-016-1433-z.
- Background: PubMed 24270169Kamdar BB, Yang J, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Brower RG, Collop NA, Needham DM. Developing, implementing, and evaluating a multifaceted quality improvement intervention to promote sleep in an ICU. Am J Med Qual. 2014 Nov-Dec;29(6):546-54. doi: 10.1177/1062860613509684. Epub 2013 Nov 22.
- Background: PubMed 23314584Kamdar BB, King LM, Collop NA, Sakamuri S, Colantuoni E, Neufeld KJ, Bienvenu OJ, Rowden AM, Touradji P, Brower RG, Needham DM. The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Crit Care Med. 2013 Mar;41(3):800-9. doi: 10.1097/CCM.0b013e3182746442.
- Background: PubMed 18226052Nicolas A, Aizpitarte E, Iruarrizaga A, Vazquez M, Margall A, Asiain C. Perception of night-time sleep by surgical patients in an intensive care unit. Nurs Crit Care. 2008 Jan-Feb;13(1):25-33. doi: 10.1111/j.1478-5153.2007.00255.x.
- Background: PubMed 11227580Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
- PCORI SHANTI-ICU Study SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biren B Kamdar, MD, MBA, MHS principal investigator
University of California, San Diego
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nighttime noise & light reduction, Clustering patient-care interactions and Non-pharmacologic sleep aids in people with Sleep Deprivation and Critical Illness, run by University of California, San Diego at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biren B Kamdar, MD, MBA, MHS (818-465-8575, bkamdar@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07840560, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.