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

NCT07496255 | Recruiting FDA Device

• 1 other identifier: 28520
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intensive Care Unit Delirium; Intensive Care Acquired Cognitive Impairment; Post Intensive Care Unit Syndrome; Virtual Reality Cognitive Training

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

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

• Explore the effects of VR-Cog on depression

  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

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

Study Arms (2)

VR-based cognitive training program

EXPERIMENTAL

Device: VR-based cognitive training program

VR-based attention control

PLACEBO COMPARATOR

Device: VR-based attention control

Interventions

VR-based attention control DEVICE

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

Also known as: VR-AC

VR-based attention control

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.

Also known as: VR-Cog

VR-based cognitive training program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Study Officials

• Sikandar Khan, DO, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sikandar Khan, DO, MS

CONTACT

(317) 274-9427; sikhan@iu.edu

Lori Rawlings, RN, BSN

CONTACT

317-274-9052; rawlingl@regenstrief.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study team staff performing outcomes assessments will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: VR-based cognitive training program (VR-Cog) vs. VR-based attention control (VR AC)

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 27, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)