Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients

Completed

• Conditions: Cognitive Impairment, Mild; Quality of Life
• Interventions: Other: Visuo-acoustic stimulation

• Registration Number: NCT03025373
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-19
• Study Start: 2017-02-01
• Primary Completion: 2018-11-30
• Study Completion: 2019-04-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart surgery patients (< 5 days)	Visuo-acoustic stimulation	Controlled visual and acoustic stimulation in a virtual reality setting
Patients - prolonged ICU stay (> 5 days)	Visuo-acoustic stimulation	Controlled visual and acoustic stimulation in a virtual reality setting

Primary Outcome Measures

Name	Time	Method
Attention measurement in patients in the intensive care unit	Changes from baseline in attention measurement during and after admission (3 Month) to the ICU	The attention is measured via explorative behaviour of the subject. This means an eye tracker is used to measure eye movements, fixation duration and number of fixations, which can be used to calculate the explorative behaviour.

Secondary Outcome Measures

Name	Time	Method
Cognitive functioning	Changes from baseline in cognitive functioning measurement after admission (3 Month) to the ICU	The cognitive abilities are examined via CERAD test battery (Consortium to Establish a Registry for Alzheimer's Disease) this includes word fluidity, Boston Naming Test (BNT), mini-mental state examination (MMSE), word list memory, constructive practice, word list retrieve, word list recognition, constructive practice (retrieve)
Quality of Life	After 3 months after admission to the ICU	The quality of life are examined via EuroQol (EQ-5D-5L) questionnaire

Trial Locations

Locations (1)

Universitätsklinik für Intensivmedizin, Inselspital; 🇨🇭 Bern, Switzerland