Virtual Reality for ICU Delirium Prevention

NCT07357389 | Recruiting FDA Device

• 1 other identifier: STUDY00004538
• Study Type: interventional
• Target: 822
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

ICU Delirium; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of ICU delirium

  From the time of study enrollment until the time of discharge from the ICU, up to 24 months from enrollment.

• ICU-LOS

  From time admitted to the ICU until discharge from the ICU, up to 24 months from enrollment.

• H-LOS

  From time admitted to the hospital until discharge from the hospital, up to 24 months from enrollment.

• Acceptability by patients

  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.

Study Arms (2)

Standard ICU delirium prevention

NO INTERVENTION

Study ICU Delirium Prevention and VR treatment

EXPERIMENTAL

Device: Virtual Reality therapeutics

Interventions

Virtual Reality therapeutics DEVICE

Patients will receive daily VR sessions for up to 5 days in addition to regular delirium prevention measures in the ICU

Study ICU Delirium Prevention and VR treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤ 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Study Officials

• Devon S Callahan, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devon S Callahan, MD

CONTACT

310-423-2402; devon.callahan@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 22, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)