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RecruitingNCT07357389Updated Mar 17, 2026

Virtual Reality for ICU Delirium Prevention

An interventional study of Virtual Reality therapeutics in ICU Delirium, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
822
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • ICU Delirium

Keywords

  • ICU Delirium
  • Virtual Reality
03

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
822 participants (estimated)

Study arms

  • No intervention
    Standard ICU delirium prevention
  • Experimental
    Study ICU Delirium Prevention and VR treatment

    Device: Virtual Reality therapeutics

Interventions

  • DeviceVirtual Reality therapeutics

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

06

What researchers measure

Primary outcomes

  1. Incidence of ICU Delirium

    Using the CAM-ICU assessment, patients will be evaluated for the development 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.

Secondary outcomes

  1. Duration of ICU delirium

    Number of days the patient experienced ICU delirium while admitted to the ICU

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

  2. ICU-LOS

    ICU length of stay

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

  3. H-LOS

    Hospital Length of stay

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

  4. Acceptability by patients

    Able to complete VR sessions as detailed in the study

    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.

  5. 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.

07

Study locations

1 of 1 sites recruiting
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07357389
Lead sponsor
Cedars-Sinai Medical Center
Responsible party
Devon Callahan (Principal Investigator, Cedars-Sinai Medical Center) — Principal investigator
First posted
Jan 22, 2026
Start date
Mar 10, 2026
Primary completion
Jan 15, 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Mar 17, 2026

Study contacts

Devon S Callahan, MD
Contact
devon.callahan@cshs.org
310-423-2402
Devon S Callahan, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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