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NCT Number: NCT07496255

Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)

The purpose of this study is to measure the feasibility, acceptability of virtual reality (VR) brain games and estimate their effect on memory, attention, and mood for ICU survivors. The VR program will be used at home through a headset and hand controls.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Sikandar Khan, DO, MS

CONTACT

[email protected]

317-274-9424

About this study

Acute respiratory failure (ARF) accounts for 2 million admissions to adult intensive care units (ICUs) in the United States annually, and up to 80% of older adults with ARF suffer delirium, a form of ICU-related acute brain dysfunction. Delirium doubles the risk for new cognitive impairment or dementia within 12 months of ICU discharge. In addition, delirium survivors frequently develop related mental health and quality of life impairments. Unfortunately, there are few effective or scalable interventions to improve cognitive outcomes for ICU survivors.

Primary Objective Aim 1: Measure the feasibility, acceptability, and adherence of VR-Cog in older adult ICU delirium survivors at risk for ICU-acquired MCI and ADRD.

Secondary Objective Aim 2: Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors.

Tertiary/Exploratory/Correlative Objectives Aim 3: Explore the effects of VR-Cog on mental health (depression and anxiety).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 50 years or older
  • English speaking
  • Admitted to the intensive care unit (ICU) with acute respiratory failure/invasive mechanical ventilation
  • Screening positive for delirium (using Richmond Agitation Sedation Scale and Confusion Assessment Method for the ICU)

Exclusion criteria

  • Acute neurologic injury such as stroke, traumatic brain injury, brain mass, intracranial hemorrhage, seizures, or central nervous system infection
  • Chronic cognitive or physical function deficit preventing participation in study interventions or assessments (determined by chart diagnoses and direct participant interview)
  • Chronic cognitive impairment (including mild cognitive impairment or dementia) identified by chart diagnosis, prescription of anti-dementia medications, or Informant Questionnaire on Cognitive Decline in the Elderly Score (IQCODE) >3.3 obtained from family caregiver
  • Severe, uncorrected vision or hearing impairment preventing participation in intervention or outcomes assessments
  • Admitted with acute alcohol or drug intoxication or withdrawal
  • Severe, uncontrolled psychiatric disorder (bipolar disorder or schizophrenia)
  • History of severe vertigo, motion-induced sickness, headaches, light sensitivity, seizures, or prior intolerance of virtual reality (VR)
  • Receiving comfort care measures or not expected to survive the hospitalization
  • Prisoners or patients unable to provide consent
  • Not expected to be discharged home from the hospital, or living more than 50 miles from the nearest recruitment site, or homeless

Treatment and study plan

VR-based cognitive training program

Device

VR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial.

Other names: VR-Cog

VR-based attention control

Device

VR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).

Other names: VR-AC

Primary outcomes

  1. Measure the feasibility of VR-Cog in older adult ICU delirium survivors

    Time frame: Feasibility will be measured at 4 weeks (the end of the intervention period)

    Feasibility will be measured by the percentage (%) of intervention sessions delivered to participants, with greater than or equal to 80% of intervention sessions completed defining feasibility.

  2. Measure the acceptability of VR-Cog in older adult ICU delirium survivors

    Time frame: Acceptability will be measured at 4 weeks (the end of the intervention period)

    Acceptability will be defined as scores of 8 or greater on each subscale of the Senior Technology Acceptance Model (STAM, Short Form with 14-items). The four subscales of the STAM measure attitudes towards technology (perceived use and effectiveness), control beliefs (ability to use the technology and complete tasks), gerontologic anxiety (feeling apprehensive or hesitant with technology applications), and general health (ability to concentrate, satisfaction with general health).

  3. Measure the adherence to VR-Cog in older adult ICU delirium survivors

    Time frame: Adherence will be measured at 4 weeks (the end of the intervention period)

    Adherence to the protocol will be assessed through rates of retention at end of 4-week intervention (80% among participants alive and out of the hospital) and completion of outcomes assessments (80% among participants alive and out of the hospital).

Secondary outcomes

  1. Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors.

    Time frame: Measured at Baseline, 4 weeks (end of intervention period), 3-Month and 6-Month follow up

    Repeatable Battery for Assessment of Neuropsychological Status (RBANS)

  2. Explore the effects of VR-Cog on depression

    Time frame: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.

    As measured by Patient Health Questionnaire (PHQ-9)

  3. Explore the effects of VR-Cog on anxiety

    Time frame: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.

    As measured by Generalized Anxiety Disorder (GAD-7) scale

Study contacts

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

Lori Rawlings, RN, BSN

CONTACT

[email protected]

317-274-9052

Sikandar Khan, DO, MS

CONTACT

[email protected]

(317) 274-9427

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 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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