Virtual RealityNCT05583903
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
A study testing Virtual Reality Software in people with Virtual Reality, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality Software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-35 years or ≥60 years
- Healthy volunteers who meet one of the following criteria according to their self-reported medical history:
- American Society of Anesthesiologists (ASA) 1: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
- ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (eg, treated hypertension, obesity with BMI under 35, frequent social drinker, but is nonsmoking).
Who cannot join
- Age <18 years; 36-59 years
- Person with active psychiatric disorders, especially schizophrenia
- Person who is deaf or blind
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
Official title: Usability and Acceptability of Virtual Reality-based Cognitive Stimulation by Healthy Participants
This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.
Read the detailed description
Virtual reality (VR) imitates reality by creating an artificial 3-D environment using computing technology or software. Using this software with a headset, a virtual environment is created, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a virtual environment allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled virtual environment. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. This trial aims to follow in similar footsteps using the gamification of exercises for cognitive stimulation in healthy volunteers to record outcomes and perform usability testing. These exercise "games" allow users to focus and pay attention to the game while helping reorient and cognitively stimulate the user's brain. The games are built with increasing difficulty and complexity of user demand and output. A novel, 3D-simulated software platform prototype called ''ReCognitionVR'' was developed to provide VR-based cognitive exercises to healthy participants for testing.
The premise of this trial is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed- environment with music.
According to our institutional review board recommendations, this pilot study will be conducted in two steps on two different cohorts which are as follows:
In the first step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercises will be evaluated on elderly healthy subjects. This study's results will inform the design of a second-step pilot study.
In the second step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercise will be evaluated for elderly surgical patients who are at high risk for the development of delirium.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality Software
- Keywords
- Young Healthy Volunteers, Elderly Healthy Volunteers, User-Centered Design, Cognitive Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SoftwareOther
Also called ReCognition Virtual Reality Software
The ReCognition virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Experimental | Healthy volunteers between the ages of 18 and 35 years will utilize the ReCognition virtual reality software Receives: Other: Virtual Reality Software |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Experimental | Healthy volunteers 60 years of age and older will utilize the ReCognition virtual reality software Receives: Other: Virtual Reality Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start
Whether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome)
Measured: 20 minutes after the start of software use
Secondary outcomes (14)
Participants With a System Usability Scale Score >35
The proportion of participants with a System Usability Scale score >35 on a scale of 0-100, where higher scores mean better usability.
Measured: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Participant High Score in Easy Mode
Participant highest score achieved utilizing the virtual reality software, on a scale of 0 to 100, where higher scores indicate better performance in the software game.
Measured: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Participant High Score in Medium Difficulty Mode
Participant highest score achieved utilizing the virtual reality software, on a scale of 0 to 100, where higher scores indicate better performance in the software game.
Measured: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Participant High Score in Hard Mode
Participant highest score achieved utilizing the virtual reality software, on a scale of 0 to 100, where higher scores indicate better performance in the software game.
Measured: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use
Heart rate measured using a vital sign monitor at baseline (immediately prior to software use) and 10 minutes after software use. Change = 10-minute heart rate - baseline heart rate
Measured: Baseline and 10 minutes
Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to software use) and 10 minutes after software use. Change = 10-minute oxygen saturation - baseline oxygen saturation
Measured: Baseline and 10 minutes
Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use
Respiratory rate at baseline (immediately prior to software use) and 10 minutes after software use. Change = 10-minute respiratory rate - baseline respiratory rate rate
Measured: Baseline and 10 minutes
Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to software use) and 10 minutes after software use. Change = 10-minute blood pressure - baseline blood pressure
Measured: Baseline and 10 minutes
Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to software use) and 10 minutes after software use. Change = 10-minute blood pressure - baseline blood pressure
Measured: Baseline and 10 minutes
Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use
Heart rate measured using a vital sign monitor at baseline (immediately prior to software use) and after completion of the software game. Change = completion heart rate - baseline heart rate
Measured: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to software use) and after completion of the software game. Change = completion oxygen saturation - baseline oxygen saturation
Measured: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use
Respiratory rate at baseline (immediately prior to software use) and after completion of the software game. Change = completion respiratory rate - baseline respiratory rate rate
Measured: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to software use) and after completion of the software game. Change = completion blood pressure - baseline blood pressure
Measured: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to software use) and after completion of the software game. Change = completion blood pressure - baseline blood pressure
Measured: Baseline and the completion of the software game, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start14 Aug 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Hina Faisal, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583903
- Sponsor's protocol ID
- PRO00033195
- Other IDs
- R03AG078857
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2022
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Acceptability of Virtual Reality-based Cognitive Stimulation by Healthy Participants
- ClinicalTrials.gov ID
- NCT05583903
- Acronym / sponsor ID
- PRO00033195
- Conditions
- Virtual Reality
- Keywords
- Young Healthy Volunteers, Elderly Healthy Volunteers, User-Centered Design, Cognitive Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.
Detailed description
Virtual reality (VR) imitates reality by creating an artificial 3-D environment using computing technology or software. Using this software with a headset, a virtual environment is created, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a virtual environment allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled virtual environment. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. This trial aims to follow in similar footsteps using the gamification of exercises for cognitive stimulation in healthy volunteers to record outcomes and perform usability testing. These exercise "games" allow users to focus and pay attention to the game while helping reorient and cognitively stimulate the user's brain. The games are built with increasing difficulty and complexity of user demand and output. A novel, 3D-simulated software platform prototype called ''ReCognitionVR'' was developed to provide VR-based cognitive exercises to healthy participants for testing.
The premise of this trial is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed- environment with music.
According to our institutional review board recommendations, this pilot study will be conducted in two steps on two different cohorts which are as follows:
In the first step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercises will be evaluated on elderly healthy subjects. This study's results will inform the design of a second-step pilot study.
In the second step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercise will be evaluated for elderly surgical patients who are at high risk for the development of delirium.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Experimental | Other: Virtual Reality SoftwareHealthy volunteers between the ages of 18 and 35 years will utilize the ReCognition virtual reality software |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Experimental | Other: Virtual Reality SoftwareHealthy volunteers 60 years of age and older will utilize the ReCognition virtual reality software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-35 years or ≥60 years
- Healthy volunteers who meet one of the following criteria according to their self-reported medical history:
Key exclusion criteria (3 listed)
- Age <18 years; 36-59 years
- Person with active psychiatric disorders, especially schizophrenia
- Person who is deaf or blind
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 |
|---|---|---|
| Virtual Reality SoftwareAlso: ReCognition Virtual Reality SoftwareThe ReCognition virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. | Other | Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years, Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years |
Primary outcome
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start
Time frame: 20 minutes after the start of software use
Whether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome)
14 secondary outcomes
Participants With a System Usability Scale Score >35
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Participant High Score in Easy Mode
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Participant High Score in Medium Difficulty Mode
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Participant High Score in Hard Mode
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use
Time frame: Baseline and 10 minutes
Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use
Time frame: Baseline and 10 minutes
Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use
Time frame: Baseline and 10 minutes
Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
Time frame: Baseline and 10 minutes
Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
Time frame: Baseline and 10 minutes
Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use
Time frame: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use
Time frame: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use
Time frame: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use
Time frame: Baseline and the completion of the software game, up to 2 hours
Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use
Time frame: Baseline and the completion of the software game, up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Software in people with Virtual Reality, run by The Methodist Hospital Research Institute 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 3 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: finished, as of the sponsor's last update on 10 Jun 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. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start (time frame: 20 minutes after the start of software use). 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 10 Jun 2026.