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Recruiting

NCT Number: NCT07357389

Virtual Reality 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.

Recruiting

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Key information

Conditions

ICU Delirium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Devon S Callahan, MD

CONTACT

[email protected]

310-423-2492

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

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

  2. ICU-LOS

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

    ICU length of stay

  3. H-LOS

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

    Hospital Length of stay

  4. 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.

    Able to complete VR sessions as detailed in the study

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Devon S Callahan, MD

CONTACT

[email protected]

310-423-2402

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

VR for ICU Delirium Prevention

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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