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.

Study Overview

• Status: Recruiting
• Conditions: Post Intensive Care Unit Syndrome; Intensive Care Unit Delirium; Intensive Care Acquired Cognitive Impairment; Virtual Reality Cognitive Training
• Intervention / Treatment: Device: VR-based cognitive training program; Device: VR-based attention control

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Rawlings, RN, BSN; Phone Number: 317-274-9052; Email: rawlingl@regenstrief.org
• Study Contact Backup: Name: Sikandar Khan, DO, MS; Phone Number: (317) 274-9427; Email: sikhan@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Methodist Hospital
      • Contact: Sikandar Khan, DO, MS; Phone Number: 317-274-9424; Email: sikhan@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-based cognitive training program	Device: VR-based cognitive training program; 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
Placebo Comparator: VR-based attention control	Device: VR-based attention control; VR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).; Other Names: VR-AC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the feasibility of VR-Cog in older adult ICU delirium survivors	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.	Feasibility will be measured at 4 weeks (the end of the intervention period)
Measure the acceptability of VR-Cog in older adult ICU delirium survivors	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).	Acceptability will be measured at 4 weeks (the end of the intervention period)
Measure the adherence to VR-Cog in older adult ICU delirium survivors	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).	Adherence will be measured at 4 weeks (the end of the intervention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors.	Repeatable Battery for Assessment of Neuropsychological Status (RBANS)	Measured at Baseline, 4 weeks (end of intervention period), 3-Month and 6-Month follow up
Explore the effects of VR-Cog on depression	As measured by Patient Health Questionnaire (PHQ-9)	Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.
Explore the effects of VR-Cog on anxiety	As measured by Generalized Anxiety Disorder (GAD-7) scale	Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health
• Investigators: Principal Investigator: Sikandar Khan, DO, MS, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 28520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No