Clinical trial NCT05583903: Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
Official title: Usability and Acceptability of Virtual Reality-based Cognitive Stimulation by Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: Young Healthy Volunteers
Elderly Healthy Volunteers
User-Centered Design
Cognitive Exercises
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start
timeFrame: 20 minutes after the start of software use
Secondary outcomes:
measure: Participants With a System Usability Scale Score >35
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Participant High Score in Easy Mode
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Participant High Score in Medium Difficulty Mode
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Participant High Score in Hard Mode
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use
timeFrame: Baseline and 10 minutes
measure: Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use
timeFrame: Baseline and 10 minutes
measure: Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use
timeFrame: Baseline and 10 minutes
measure: Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
timeFrame: Baseline and 10 minutes
measure: Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
timeFrame: Baseline and 10 minutes
measure: Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use
timeFrame: Baseline and the completion of the software game, up to 2 hours
measure: Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use
timeFrame: Baseline and the completion of the software game, up to 2 hours
measure: Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use
timeFrame: Baseline and the completion of the software game, up to 2 hours
measure: Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use
timeFrame: Baseline and the completion of the software game, up to 2 hours
measure: Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use
timeFrame: Baseline and the completion of the software game, up to 2 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
References: