Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention

Not Applicable

Completed

• Conditions: Virtual Reality
• Interventions: Other: Virtual Reality Software

• Registration Number: NCT05583903
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Study Timeline

• Study Start: 2022-08-14
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-18
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30
• Results First Submitted: 2023-07-11
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Results First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

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Exclusion Criteria

• Age <18 years; 36-59 years
• Person with active psychiatric disorders, especially schizophrenia
• Person who is deaf or blind

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years	Virtual Reality Software	Healthy 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	Virtual Reality Software	Healthy volunteers 60 years of age and older will utilize the ReCognition virtual reality software

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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 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 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
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.
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 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 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 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 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

Trial Locations

Locations (1)

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States