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

Virtual Reality Clinical Trial

Official title:

Usability and Acceptability of Virtual Reality-based Cognitive Stimulation by Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05583903
• Other study ID #: PRO00033195
• Secondary ID: R03AG078857
• Status: Completed
• Phase: N/A
• Start date: August 14, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Virtual Reality

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Houston Methodist Research Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	20 minutes after the start of software use
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.	After completion of use of the virtual reality software, up to 2 hours after the start of software use
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.	After completion of use of the virtual reality software, up to 2 hours after the start of software use
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.	After completion of use of the virtual reality software, up to 2 hours after the start of software use
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.	After completion of use of the virtual reality software, up to 2 hours after the start of software use
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	Baseline and 10 minutes
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	Baseline and 10 minutes
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	Baseline and 10 minutes
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	Baseline and 10 minutes
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	Baseline and 10 minutes
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	Baseline and the completion of the software game, up to 2 hours
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	Baseline and the completion of the software game, up to 2 hours
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	Baseline and the completion of the software game, up to 2 hours
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	Baseline and the completion of the software game, up to 2 hours
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	Baseline and the completion of the software game, up to 2 hours