Virtual Reality
Conditions
Keywords
Young Healthy Volunteers, Elderly Healthy Volunteers, User-Centered Design, Cognitive Exercises
Brief 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.
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.
Interventions
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.
Sponsors
The Methodist Hospital Research Institute
National Institute on Aging (NIA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18-35 years or ≥60 years * Healthy volunteers who meet one of the following criteria according to their self-reported medical history: 1. American Society of Anesthesiologists (ASA) 1: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance. 2. 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).
Exclusion criteria
* Age \<18 years; 36-59 years * Person with active psychiatric disorders, especially schizophrenia * Person who is deaf or blind
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With a System Usability Scale Score >35 | After completion of use of the virtual reality software, up to 2 hours after the start of software use | The proportion of participants with a System Usability Scale score \>35 on a scale of 0-100, where higher scores mean better usability. |
| Participant High Score in Easy Mode | After completion of use of the virtual reality software, up to 2 hours after the start of software use | 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. |
| Participant High Score in Medium Difficulty Mode | After completion of use of the virtual reality software, up to 2 hours after the start of software use | 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. |
| Participant High Score in Hard Mode | After completion of use of the virtual reality software, up to 2 hours after the start of software use | 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. |
| Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use | Baseline and 10 minutes | 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 |
| Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use | Baseline and 10 minutes | 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 |
| Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use | Baseline and 10 minutes | Respiratory rate at baseline (immediately prior to software use) and 10 minutes after software use. Change = 10-minute respiratory rate - baseline respiratory rate rate |
| Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use | Baseline and 10 minutes | 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 |
| Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use | Baseline and 10 minutes | 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 |
| Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use | Baseline and the completion of the software game, up to 2 hours | 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 |
| Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use | Baseline and the completion of the software game, up to 2 hours | 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 |
| Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use | Baseline and the completion of the software game, up to 2 hours | Respiratory rate at baseline (immediately prior to software use) and after completion of the software game. Change = completion respiratory rate - baseline respiratory rate rate |
| Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use | Baseline and the completion of the software game, up to 2 hours | 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 |
| Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use | Baseline and the completion of the software game, up to 2 hours | 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 |
Countries
United States
Participant flow
Pre-assignment details
Of 30 enrolled participants, 29 met inclusion criteria. One participant in Arm 2 (Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years) completed the study but was outside the limit for BMI and could not be counted in the efficacy endpoints. However, because they completed the study, they were counted in the safety endpoints only.
Participants by arm
| Arm | Count |
|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years (ASA1) Healthy volunteers between the ages of 18 and 35 years will utilize the ReCognition virtual reality software
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. | 15 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years (ASA2) Healthy volunteers 60 years of age and older will utilize the ReCognition virtual reality software
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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years (ASA2) | Total | Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years (ASA1) |
|---|---|---|---|
| Age, Continuous | 65 years | 47.5 years | 28 years |
| Body Mass Index, continuous | 25.2 kg/m2 | 24.5 kg/m2 | 23.6 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 28 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of diabetes | 2 Participants | 2 Participants | 0 Participants |
| History of hypercholesterolemia | 3 Participants | 3 Participants | 0 Participants |
| History of hypertension | 6 Participants | 6 Participants | 0 Participants |
| Non-smoker | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 14 Participants | 9 Participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 2 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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)
Time frame: 20 minutes after the start of software use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start | 15 Participants |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start | 14 Participants |
p-value: 1Fisher Exact
Secondary
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
Time frame: Baseline and 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use | -0.33 mm Hg | Standard Deviation 5.59 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use | 1.53 mm Hg | Standard Deviation 5.32 |
p-value: 0.36Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and the completion of the software game, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use | -0.07 mm Hg | Standard Deviation 6.52 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use | -3.00 mm Hg | Standard Deviation 11.43 |
p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use | -0.53 beats per minute | Standard Deviation 3.46 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use | 2.2 beats per minute | Standard Deviation 7.59 |
p-value: 0.21Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and the completion of the software game, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use | -0.4 beats per minute | Standard Deviation 3.81 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use | 1.07 beats per minute | Standard Deviation 5.97 |
p-value: 0.43Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use | -.2 percent oxygen saturation | Standard Deviation 1.01 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use | -0.07 percent oxygen saturation | Standard Deviation 0.59 |
p-value: 0.66Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and the completion of the software game, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use | -0.33 percent oxygen saturation | Standard Deviation 0.82 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use | 0.00 percent oxygen saturation | Standard Deviation 0.65 |
p-value: 0.23Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use | 1.2 breaths per minute | Standard Deviation 2.62 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use | 0.93 breaths per minute | Standard Deviation 2.31 |
p-value: 0.77Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and the completion of the software game, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use | 1.07 breaths per minute | Standard Deviation 2.22 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use | 0.67 breaths per minute | Standard Deviation 2.32 |
p-value: 0.63Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use | 1.47 mm Hg | Standard Deviation 12.06 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use | 0.13 mm Hg | Standard Deviation 7 |
p-value: 0.71Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline and the completion of the software game, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use | 5.4 mm Hg | Standard Deviation 10.54 |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use | 3.00 mm Hg | Standard Deviation 8.07 |
p-value: 0.52Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Participant High Score in Easy Mode | 100 score on a scale |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Participant High Score in Easy Mode | 100 score on a scale |
p-value: 0.57Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Participant High Score in Hard Mode | 100 score on a scale |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Participant High Score in Hard Mode | 95 score on a scale |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Participant High Score in Medium Difficulty Mode | 100 score on a scale |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Participant High Score in Medium Difficulty Mode | 99 score on a scale |
p-value: 0.2Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years | Participants With a System Usability Scale Score >35 | 11 Participants |
| Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years | Participants With a System Usability Scale Score >35 | 7 Participants |
p-value: 0.26Fisher Exact