Virtual Reality for ICU Delirium Prevention

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.

Study Overview

• Status: Recruiting
• Conditions: ICU Delirium
• Intervention / Treatment: Device: Virtual Reality therapeutics

• Study Type: Interventional
• Enrollment (Estimated): 822
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devon S Callahan, MD; Phone Number: 310-423-2402; Email: devon.callahan@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
      • Contact: Devon S Callahan, MD; Phone Number: 310-423-2492; Email: devon.callahan@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard ICU delirium prevention
Experimental: Study ICU Delirium Prevention and VR treatment	Device: Virtual Reality therapeutics; Patients will receive daily VR sessions for up to 5 days in addition to regular delirium prevention measures in the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ICU Delirium	Using the CAM-ICU assessment, patients will be evaluated for the development of ICU delirium	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of ICU delirium	Number of days the patient experienced ICU delirium while admitted to the ICU	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	From time admitted to the ICU until discharge from the ICU, up to 24 months from enrollment.
H-LOS	Hospital Length of stay	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	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		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.

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Devon S Callahan, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; ICU Delirium
• Other Study ID Numbers: STUDY00004538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes