Immersive Virtual Reality in Mechanically Ventilated Patients

NCT03569358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-04

No results posted yet for this study

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569358 on ClinicalTrials.gov