Recruiting

VR

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT07357389

Conditions

ICU Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Virtual Reality therapeutics

Study Details

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

Study ID

NCT07357389

Start date

Mar 10, 2026

Status verified date

Jan, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

822 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard ICU delirium prevention

experimental: Study ICU Delirium Prevention and VR treatment

Interventions

Virtual Reality therapeutics

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

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. ]

Central Contacts and Locations

Central contacts

Devon S Callahan, MD

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

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Devon S Callahan, MD

310-423-2492devon.callahan@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Mar 17, 2026

Last verified

Jan, 2026

Keywords

  • ICU Delirium
  • Virtual Reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-03-17.