N/A
N=30
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
Virtual Reality
Bottom Line
View on ClinicalTrials.gov: NCT05583903 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start — 15; 14 Participants — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Reality Software (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start |
15; 14 | 1.00 |
| SECONDARY Participants With a System Usability Scale Score >35 |
11; 7 | 0.26 |
| SECONDARY Participant High Score in Easy Mode |
100; 100 | 0.57 |
| SECONDARY Participant High Score in Medium Difficulty Mode |
100; 99 | 0.2 |
| SECONDARY Participant High Score in Hard Mode |
100; 95 | 0.001 sig |
| SECONDARY Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use |
-0.53; 2.2 | 0.21 |
| SECONDARY Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use |
-.2; -0.07 | 0.66 |
| SECONDARY Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use |
1.2; 0.93 | 0.77 |
| SECONDARY Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use |
1.47; 0.13 | 0.71 |
| SECONDARY Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use |
-0.33; 1.53 | 0.36 |
| SECONDARY Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use |
-0.4; 1.07 | 0.43 |
| SECONDARY Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use |
-0.33; 0.00 | 0.23 |
| SECONDARY Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use |
1.07; 0.67 | 0.63 |
| SECONDARY Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use |
5.4; 3.00 | 0.52 |
| SECONDARY Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use |
-0.07; -3.00 | 0.4 |
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.
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:
- 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).
Exclusion Criteria
- Age <18 years; 36-59 years
- Person with active psychiatric disorders, especially schizophrenia
- Person who is deaf or blind
Data sourced from ClinicalTrials.gov (NCT05583903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.