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

May 2, 2019 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Universitätsklinik für Intensivmedizin, Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consist of adults on the intensive care unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention measurement in patients in the intensive care unit
Time Frame: 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.
Changes from baseline in attention measurement during and after admission (3 Month) to the ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: After 3 months after admission to the ICU
The quality of life are examined via EuroQol (EQ-5D-5L) questionnaire
After 3 months after admission to the ICU
Cognitive functioning
Time Frame: 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)
Changes from baseline in cognitive functioning measurement after admission (3 Month) to the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

University of Bern

Investigators

  • Study Chair: Marie- Madlen Jeitziner, Dr., University Hospital of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01652

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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