Intensive Care Unit DeliriumNCT07496255
Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)
A study testing VR-based cognitive training program in people with Intensive Care Unit Delirium and Intensive Care Acquired Cognitive Impairment, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intensive Care Unit Delirium, Intensive Care Acquired Cognitive Impairment, Post Intensive Care Unit Syndrome
- What is being tested?
- VR-based cognitive training program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Sikandar Khan, DO, MS, 317-274-9424, sikhan@iu.edu
About this study
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.
Read the 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).
- Conditions
- Intensive Care Unit Delirium, Intensive Care Acquired Cognitive Impairment, Post Intensive Care Unit Syndrome, Virtual Reality Cognitive Training
- Being tested
- VR-based cognitive training program, VR-based attention control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based cognitive training programDevice
Also called VR-Cog
VR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial.
VR-based attention controlDevice
Also called VR-AC
VR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).
| Study group | Role | What they receive |
|---|---|---|
| VR-based cognitive training program | Experimental | Not described Receives: Device: VR-based cognitive training program |
| VR-based attention control | Placebo comparator | Not described Receives: Device: VR-based attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Measured: 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: 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: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start19 Mar 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- VR-based cognitive training program (VR-Cog) vs. VR-based attention control (VR AC)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Sikandar Khan, Indiana University
- Investigators
- Sikandar Khan, DO, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496255
- Sponsor's protocol ID
- 28520
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)
- ClinicalTrials.gov ID
- NCT07496255
- Acronym / sponsor ID
- 28520
- Conditions
- Intensive Care Unit Delirium, Intensive Care Acquired Cognitive Impairment, Post Intensive Care Unit Syndrome, Virtual Reality Cognitive Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- VR-based cognitive training program (VR-Cog) vs. VR-based attention control (VR AC)
| Arm | Type | Receives |
|---|---|---|
| VR-based cognitive training program | Experimental | Device: VR-based cognitive training program |
| VR-based attention control | Placebo comparator | Device: VR-based attention control |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-based cognitive training programAlso: VR-CogVR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial. | Device | VR-based cognitive training program |
| VR-based attention controlAlso: VR-ACVR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR). | Device | VR-based attention control |
Primary outcome
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.
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).
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).
3 secondary outcomes
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sikandar Khan, DO, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based cognitive training program in people with Intensive Care Unit Delirium and Intensive Care Acquired Cognitive Impairment, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sikandar Khan, DO, MS ((317) 274-9427, sikhan@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.