Immersive Virtual Reality in Mechanically Ventilated Patients
NCT03569358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-02-04
Summary
New or worsening cognitive impairment occurs in up to 58% of survivors of critical illnesses and are long-lasting with significant disability and socioeconomic cost. There are currently no known interventions that reduce the incidence of cognitive impairment after critical illnesses. Immersive Virtual Reality (IVR) is the use of technology to create a perception of presence in a three-dimensional, computer-generated interactive simulated environment. Prior clinical studies have demonstrated potential efficacy in rehabilitation of severe traumatic brain injury.
The investigators propose a preliminary study for the evaluation of safety, tolerability, and early efficacy of immersive virtual reality for early neurocognitive stimulation in critically-ill, mechanically ventilated patients. The investigators hypothesize that the use of IVR technology for early neurocognitive simulation is safe and tolerable in these patients. This study will also evaluate whether early application of IVR in critically ill, mechanically ventilated subjects, can provide neurocognitive stimulation.
30 patients admitted to the intensive care unit for acute respiratory failure or septic shock will be evaluated for recruitment. 10 patients will be in the control group and 20 patients would have 2 sessions of IVR planned daily for a maximum of 3 days. Assessment of safety will involve monitoring for physiological derangements in heart rate, respiratory rate, pulse oximetry and blood pressure during the IVR session. Assessment of tolerability will involve monitoring for increased agitation. Assessment of early efficacy will involve evaluation of visual attention during the IVR session. 5-channel electroencephalogram would aim to detect objective changes in visual event-related potentials and the IVR headgear will incorporate eye-tracking technology.
To conclude, should IVR be feasible and safe, future interventional studies may be planned to investigate its impact on reduction in the use of sedatives, analgesia, delirium incidence and severity of cognitive impairment associated with critical illness.
Conditions
- Mechanical Ventilation
- Virtual Reality
- Delirium
Interventions
- DEVICE
-
Immersive Virtual Reality
The immersive virtual reality headgear used is the commercially available FOVE VR headset. It incorporates a 2560x1440 pixel display, position tracking-and eye-tracking. The headset weight 520g with adjustable velcro straps. Softwares are run via a computer connected by HDMI or USB cables.
- DEVICE
-
EEG headband
The EEG headband is commercially available MUSE band. It incorporates 4-channel dry electrode EEG system where data can be recorded with bluetooth connection.
Sponsors & Collaborators
-
BetaSight Technologies Pte Ltd
collaborator UNKNOWN -
Institute for Infocomm Research
collaborator OTHER -
Changi General Hospital
lead OTHER
Principal Investigators
-
Jessica LS Quah, M.B.B.S. · Changi General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-07-02
- Primary Completion
- 2019-07-02
- Completion
- 2019-07-02
Countries
- Singapore
Study Locations
More Related Trials
-
Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders
NCT06597591 ·Status: RECRUITING ·Phase: NA
-
Assessment of the Cognitive Load of the Landed Combatant in Virtual Reality.
NCT05676424 ·Status: UNKNOWN
-
Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
NCT02832921 ·Status: UNKNOWN ·Phase: NA
-
Cognition Assessment and REhabilitation in Virtual Reality for Patients With Cancer
NCT07335393 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19
NCT04505761 ·Status: COMPLETED ·Phase: NA
-
Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment
NCT06838494 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Virtual Reality Cognitive Therapy for Alzheimer's Disease
NCT05788848 ·Status: COMPLETED ·Phase: PHASE1
-
VR-based Multi-dimensional Intervention on Cognitive Function, With AI-agents
NCT07064382 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effectiveness of a Cognitive Remediation Intervention Based on Virtual Reality for Promotion of Cognitive Functioning and Participation in Daily Life Among Persons With Affective Disorder
NCT04288609 ·Status: UNKNOWN ·Phase: NA
-
Virtual Reality Cognitive Training for Older Adults With Mild Cognitive Impairment
NCT06392412 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
NCT05583903 ·Status: COMPLETED ·Phase: NA
-
Immersive Virtual Reality in Cognitive Rehabilitation of Patients With Post-Stroke Cognitive Impairment
NCT07125170 ·Status: RECRUITING ·Phase: NA
-
Neurocognitive Rehabilitation Using Virtual Reality
NCT04017091 ·Status: COMPLETED ·Phase: NA
-
Enhancing Brain Training With Virtual Reality
NCT03582579 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Combinated Cues and Virtual Spatial Navigation
NCT03534128 ·Status: UNKNOWN ·Phase: NA
-
Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
NCT03196739 ·Status: COMPLETED ·Phase: NA
-
Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator on Institutionalized Dementia Patients
NCT06419257 ·Status: RECRUITING ·Phase: NA
-
Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI)
NCT06313931 ·Status: COMPLETED ·Phase: NA
-
Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study
NCT06074328 ·Status: COMPLETED ·Phase: NA
-
The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation
NCT06234930 ·Status: COMPLETED ·Phase: NA
-
Immersive VR Environments to Induce and Evaluate Cognitive Fatigability
NCT04883359 ·Status: TERMINATED
-
Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation
NCT03359902 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Cognitive Rehabilitation Using Virtual Reality and Computer-based Cognitive Stimulation on Cognitive Impairment Associated to Movement Disorders
NCT05769972 ·Status: COMPLETED ·Phase: NA
-
VR-based Intervention for Cognitive Restoration
NCT05653596 ·Status: RECRUITING ·Phase: NA
-
Additional Effects of Immersive vr 360 Degree Videos With Aerobic Exercises on Cognitive Functions in Elderly With Mild Cognitive Impairment
NCT07242495 ·Status: RECRUITING ·Phase: NA