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Completed

NCT Number: NCT03025373

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

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.

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Key information

Conditions

Cognitive Impairment, Mild Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Intensivmedizin, Inselspital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visuo-acoustic stimulation

Other

Controlled visual and acoustic stimulation in a virtual reality setting

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 19, 2017
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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