ICU DeliriumNCT07357389
Virtual Reality for ICU Delirium Prevention
A study testing Virtual Reality therapeutics in people with ICU Delirium, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether daily exposure to immersive virtual reality (VR) can reduce the incidence of delirium in high-risk, non-intubated ICU patients. Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ICU Delirium
- What is being tested?
- Virtual Reality therapeutics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to Apr 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are currently admitted to the SICU at Cedars-Sinai Medical Center
- Expected ICU stay >48 hours
- Richmond Agitation Sedation Scale (RASS) score between -1 to +2.
- CAM-ICU negative
- 1≤ risk factor for delirium (Age ≥ 65 years old, history of cognitive impairment, sepsis, Sequential Organ Failure Assessment (SOFA) score >5, history of alcohol or benzodiazepine abuse, recent major surgery)
Who cannot join
- Unwilling and/or unable to participate
- Intubation of tracheostomy
- Self-reported history of severe motion sickness
- Inability to follow commands (e.g. severe aphasia, deafness, GCS<13)
- The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted device (HMD
- Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses
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- Having had a seizure in the past year
- Unable to understand the instructions or to consent to participation in the study.
- Those who are pregnant
- Hemodynamic instability (MAP<65 despite support)
- End-of-life care
- Severe agitation or delirium (i.e. CAM-ICU + screen)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Devon S Callahan, MD, 310-423-2492, devon.callahan@cshs.org
About this study
Official title: VR for ICU Delirium Prevention
The purpose of this study is to evaluate whether daily exposure to immersive virtual reality (VR) can reduce the incidence of delirium in high-risk, non-intubated ICU patients. Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming natural scenes, guided meditation, and music. The study population includes adult surgical ICU patients at Cedars-Sinai who are CAM-ICU negative at enrollment and possess at least one established risk factor for delirium. Outcomes will include the incidence and duration of delirium, ICU and hospital length of stay, feasibility of the VR intervention, and the frequency of adverse events. By targeting a high-risk population with an innovative non-pharmacologic therapy, this trial aims to generate data to support integration of VR into ICU delirium prevention protocols.
- Conditions
- ICU Delirium
- Being tested
- Virtual Reality therapeutics
- Keywords
- ICU Delirium, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality therapeuticsDevice
Patients will receive daily VR sessions for up to 5 days in addition to regular delirium prevention measures in the ICU
| Study group | Role | What they receive |
|---|---|---|
| Standard ICU delirium prevention | No intervention | Not described |
| Study ICU Delirium Prevention and VR treatment | Experimental | Not described Receives: Device: Virtual Reality therapeutics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ICU Delirium
Using the CAM-ICU assessment, patients will be evaluated for the development of ICU delirium
Measured: From enrollment in the study until ICU discharge. Assessed Day 1 in the morning and evening for the duration of the ICU admission, up to 24 months from enrollment.
Secondary outcomes (5)
Duration of ICU delirium
Number of days the patient experienced ICU delirium while admitted to the ICU
Measured: From the time of study enrollment until the time of discharge from the ICU, up to 24 months from enrollment.
ICU-LOS
ICU length of stay
Measured: From time admitted to the ICU until discharge from the ICU, up to 24 months from enrollment.
H-LOS
Hospital Length of stay
Measured: From time admitted to the hospital until discharge from the hospital, up to 24 months from enrollment.
Acceptability by patients
Able to complete VR sessions as detailed in the study
Measured: From time enrolled in the study until the patient has completed the study interventions (either on discharge from the ICU or after 5 days of interventions, whichever comes first), from Day 1 until Day 5 after enrollment.
Number of adverse events
Measured: Adverse events related to VR, such as nausea, dizziness, seizures, will be assessed from the time of enrollment in the study up until the time of discharge from the hospital, from time of enrollment on Day 1 until Day 5 after enrollment, if applicable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start10 Mar 2026
- Primary completion15 Jan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU DeliriumStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 822 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devon Callahan, Cedars-Sinai Medical Center
- Investigators
- Devon S Callahan, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357389
- Sponsor's protocol ID
- STUDY00004538
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR for ICU Delirium Prevention
- ClinicalTrials.gov ID
- NCT07357389
- Acronym / sponsor ID
- STUDY00004538
- Conditions
- ICU Delirium
- Keywords
- ICU Delirium, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 822 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Jan 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.
The purpose of this study is to evaluate whether daily exposure to immersive virtual reality (VR) can reduce the incidence of delirium in high-risk, non-intubated ICU patients. Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming natural scenes, guided meditation, and music. The study population includes adult surgical ICU patients at Cedars-Sinai who are CAM-ICU negative at enrollment and possess at least one established risk factor for delirium. Outcomes will include the incidence and duration of delirium, ICU and hospital length of stay, feasibility of the VR intervention, and the frequency of adverse events. By targeting a high-risk population with an innovative non-pharmacologic therapy, this trial aims to generate data to support integration of VR into ICU delirium prevention protocols.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ICU delirium prevention | No intervention | – |
| Study ICU Delirium Prevention and VR treatment | Experimental | Device: Virtual Reality therapeutics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who are currently admitted to the SICU at Cedars-Sinai Medical Center
- Expected ICU stay >48 hours
- Richmond Agitation Sedation Scale (RASS) score between -1 to +2.
- CAM-ICU negative
- 1≤ risk factor for delirium (Age ≥ 65 years old, history of cognitive impairment, sepsis, Sequential Organ Failure Assessment (SOFA) score >5, history of alcohol or benzodiazepine abuse, recent major surgery)
Key exclusion criteria (12 listed)
- Unwilling and/or unable to participate
- Intubation of tracheostomy
- Self-reported history of severe motion sickness
- Inability to follow commands (e.g. severe aphasia, deafness, GCS<13)
- The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted device (HMD
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 |
|---|---|---|
| Virtual Reality therapeuticsPatients will receive daily VR sessions for up to 5 days in addition to regular delirium prevention measures in the ICU | Device | Study ICU Delirium Prevention and VR treatment |
Primary outcome
Incidence of ICU Delirium
Time frame: From enrollment in the study until ICU discharge. Assessed Day 1 in the morning and evening for the duration of the ICU admission, up to 24 months from enrollment.
Using the CAM-ICU assessment, patients will be evaluated for the development of ICU delirium
5 secondary outcomes
Duration of ICU delirium
Time frame: From the time of study enrollment until the time of discharge from the ICU, up to 24 months from enrollment.
ICU-LOS
Time frame: From time admitted to the ICU until discharge from the ICU, up to 24 months from enrollment.
H-LOS
Time frame: From time admitted to the hospital until discharge from the hospital, up to 24 months from enrollment.
Acceptability by patients
Time frame: From time enrolled in the study until the patient has completed the study interventions (either on discharge from the ICU or after 5 days of interventions, whichever comes first), from Day 1 until Day 5 after enrollment.
Number of adverse events
Time frame: Adverse events related to VR, such as nausea, dizziness, seizures, will be assessed from the time of enrollment in the study up until the time of discharge from the hospital, from time of enrollment on Day 1 until Day 5 after enrollment, if applicable.
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 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Devon S Callahan, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality therapeutics in people with ICU Delirium, run by Cedars-Sinai Medical Center at 1 site in United States.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Devon S Callahan, MD (310-423-2402, devon.callahan@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ICU Delirium (time frame: From enrollment in the study until ICU discharge. Assessed Day 1 in the morning and evening for the duration of the ICU admission, up to 24 months from enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.