Trial Outcomes & Findings for Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention (NCT NCT05583903)
NCT ID: NCT05583903
Last Updated: 2023-11-21
Results Overview
Whether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
20 minutes after the start of software use
Results posted on
2023-11-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
Baseline characteristics by cohort
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years (ASA1)
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years (ASA2)
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
n=99 Participants
|
65 years
n=107 Participants
|
47.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Body Mass Index, continuous
|
23.6 kg/m2
n=99 Participants
|
25.2 kg/m2
n=107 Participants
|
24.5 kg/m2
n=206 Participants
|
|
Non-smoker
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
History of hypertension
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
History of diabetes
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
History of hypercholesterolemia
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 20 minutes after the start of software useWhether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome)
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=14 Participants
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.
|
|---|---|---|
|
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: After completion of use of the virtual reality software, up to 2 hours after the start of software useThe proportion of participants with a System Usability Scale score \>35 on a scale of 0-100, where higher scores mean better usability.
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=14 Participants
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.
|
|---|---|---|
|
Participants With a System Usability Scale Score >35
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: After completion of use of the virtual reality software, up to 2 hours after the start of software useParticipant 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.
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=14 Participants
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.
|
|---|---|---|
|
Participant High Score in Easy Mode
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: After completion of use of the virtual reality software, up to 2 hours after the start of software useParticipant 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.
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=14 Participants
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.
|
|---|---|---|
|
Participant High Score in Medium Difficulty Mode
|
100 score on a scale
Interval 97.0 to 100.0
|
99 score on a scale
Interval 96.0 to 100.0
|
SECONDARY outcome
Timeframe: After completion of use of the virtual reality software, up to 2 hours after the start of software useParticipant 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.
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=14 Participants
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.
|
|---|---|---|
|
Participant High Score in Hard Mode
|
100 score on a scale
Interval 97.0 to 100.0
|
95 score on a scale
Interval 92.0 to 98.0
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesHeart 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use
|
-0.53 beats per minute
Standard Deviation 3.46
|
2.2 beats per minute
Standard Deviation 7.59
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesPulse 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes of Virtual Reality Software Use
|
-.2 percent oxygen saturation
Standard Deviation 1.01
|
-0.07 percent oxygen saturation
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesRespiratory rate at baseline (immediately prior to software use) and 10 minutes after software use. Change = 10-minute respiratory rate - baseline respiratory rate rate
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Respiratory Rate After 10 Minutes of Virtual Reality Software Use
|
1.2 breaths per minute
Standard Deviation 2.62
|
0.93 breaths per minute
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesSystolic 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
|
1.47 mm Hg
Standard Deviation 12.06
|
0.13 mm Hg
Standard Deviation 7.00
|
SECONDARY outcome
Timeframe: Baseline and 10 minutesDiastolic 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure After 10 Minutes of Virtual Reality Software Use
|
-0.33 mm Hg
Standard Deviation 5.59
|
1.53 mm Hg
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: Baseline and the completion of the software game, up to 2 hoursHeart 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Heart Rate After Completion of Virtual Reality Software Use
|
-0.4 beats per minute
Standard Deviation 3.81
|
1.07 beats per minute
Standard Deviation 5.97
|
SECONDARY outcome
Timeframe: Baseline and the completion of the software game, up to 2 hoursPulse 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion of Virtual Reality Software Use
|
-0.33 percent oxygen saturation
Standard Deviation 0.82
|
0.00 percent oxygen saturation
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline and the completion of the software game, up to 2 hoursRespiratory rate at baseline (immediately prior to software use) and after completion of the software game. Change = completion respiratory rate - baseline respiratory rate rate
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Respiratory Rate After Completion of Virtual Reality Software Use
|
1.07 breaths per minute
Standard Deviation 2.22
|
0.67 breaths per minute
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: Baseline and the completion of the software game, up to 2 hoursSystolic 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure After Completion of Virtual Reality Software Use
|
5.4 mm Hg
Standard Deviation 10.54
|
3.00 mm Hg
Standard Deviation 8.07
|
SECONDARY outcome
Timeframe: Baseline and the completion of the software game, up to 2 hoursDiastolic 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
Outcome measures
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 Participants
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 Participants
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.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure After Completion of Virtual Reality Software Use
|
-0.07 mm Hg
Standard Deviation 6.52
|
-3.00 mm Hg
Standard Deviation 11.43
|
Adverse Events
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Virtual Reality Software Usability in Healthy Volunteers Age 18-35 Years
n=15 participants at risk
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.
|
Virtual Reality Software Usability in Healthy Volunteers Age 60 or Greater Years
n=15 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Transient increase in systolic blood pressure
|
6.7%
1/15 • Number of events 1 • The duration of the participant's activity in the study (approximately 20 minutes)
Neurological: Main clusters of cybersickness: gastrointestinal (e.g., stomach awareness, nausea, vomiting), central (e.g., fainting, lightheadedness, blurred vision, disorientation, dizziness), peripheral (e.g., sweating, feeling hot), sopite (e.g., annoyance, drowsiness, tiredness, uneasiness). Cardiovascular: New-onset hypotension, bradycardia (HR \< 50 bpm), tachycardia (HR \>130 bpm) Pulmonary: New-onset hypoxia (SpO2 \<88%) and tachypnea (respiratory rate \>20).
|
0.00%
0/15 • The duration of the participant's activity in the study (approximately 20 minutes)
Neurological: Main clusters of cybersickness: gastrointestinal (e.g., stomach awareness, nausea, vomiting), central (e.g., fainting, lightheadedness, blurred vision, disorientation, dizziness), peripheral (e.g., sweating, feeling hot), sopite (e.g., annoyance, drowsiness, tiredness, uneasiness). Cardiovascular: New-onset hypotension, bradycardia (HR \< 50 bpm), tachycardia (HR \>130 bpm) Pulmonary: New-onset hypoxia (SpO2 \<88%) and tachypnea (respiratory rate \>20).
|
|
Nervous system disorders
Transient vague uneasiness
|
6.7%
1/15 • Number of events 1 • The duration of the participant's activity in the study (approximately 20 minutes)
Neurological: Main clusters of cybersickness: gastrointestinal (e.g., stomach awareness, nausea, vomiting), central (e.g., fainting, lightheadedness, blurred vision, disorientation, dizziness), peripheral (e.g., sweating, feeling hot), sopite (e.g., annoyance, drowsiness, tiredness, uneasiness). Cardiovascular: New-onset hypotension, bradycardia (HR \< 50 bpm), tachycardia (HR \>130 bpm) Pulmonary: New-onset hypoxia (SpO2 \<88%) and tachypnea (respiratory rate \>20).
|
0.00%
0/15 • The duration of the participant's activity in the study (approximately 20 minutes)
Neurological: Main clusters of cybersickness: gastrointestinal (e.g., stomach awareness, nausea, vomiting), central (e.g., fainting, lightheadedness, blurred vision, disorientation, dizziness), peripheral (e.g., sweating, feeling hot), sopite (e.g., annoyance, drowsiness, tiredness, uneasiness). Cardiovascular: New-onset hypotension, bradycardia (HR \< 50 bpm), tachycardia (HR \>130 bpm) Pulmonary: New-onset hypoxia (SpO2 \<88%) and tachypnea (respiratory rate \>20).
|
Additional Information
Dr. Hina Faisal
Department of Surgery, Houston Methodist Hospital
Phone: 713-714-4973
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place