Clinical trial NCT03025373: Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients
Official title: Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment, Mild
Quality of Life
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2017-01-19
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consist of adults on the intensive care unit

Brief summary: An observational study will be conducted in the ICU (Intensive care unit) including patients with heart surgery (\< 5 days) and prolonged ICU stay (\> 5 days). Patients will receive 5 min Virtual reality stimulation per day. A modified version of the Oculus Rift VR glasses (Facebook inc., USA) with stereoscopic vision and stereo sound will be used to present the virtual world to patients. An integrated eye tracker will measure oculomotor responses that will be synchronized with the physiological data recording. All participants will undergo neuropsychological testing after ICU stay, and after a three-months follow-up. Quality of life prior to the ICU stay will be enquired from relatives. Main outcome variable is the explorative behaviour (attention). Secondary outcomes are the quality of life and cognitive functioning.


Eligibility criteria: Inclusion Criteria:

* Age \> =18
* Speak German or French
* Are able to participate the follow up measurements
* Written informed consent

Exclusion Criteria:

* Visual impairments
* Cognitive impairments
* Cognitive impairments
* Craniocerebral injury before admitting the ICU
* Already admitted the intensive care unit (last year) or at reentry
* Psychotic disorders

Primary outcomes:
measure: Attention measurement in patients in the intensive care unit
timeFrame: Changes from baseline in attention measurement during and after admission (3 Month) to the ICU
Secondary outcomes:
measure: Quality of Life
timeFrame: After 3 months after admission to the ICU
measure: Cognitive functioning
timeFrame: Changes from baseline in cognitive functioning measurement after admission (3 Month) to the ICU
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsklinik für Intensivmedizin, Inselspital
Study officials:
affiliation: University hospital of Bern
name: Marie- Madlen Jeitziner, Dr.
role: STUDY_CHAIR
References:
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citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
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