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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025373
• Other study ID #: 2016-01652
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: May 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 1, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Quality of Life

Intervention

Other:
• Visuo-acoustic stimulation
Controlled visual and acoustic stimulation in a virtual reality setting

Locations

Country	Name	City	State
Switzerland	Universitätsklinik für Intensivmedizin, Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21. — View Citation

Brummel NE, Jackson JC, Girard TD, Pandharipande PP, Schiro E, Work B, Pun BT, Boehm L, Gill TM, Ely EW. A combined early cognitive and physical rehabilitation program for people who are critically ill: the activity and cognitive therapy in the intensive care unit (ACT-ICU) trial. Phys Ther. 2012 Dec;92(12):1580-92. doi: 10.2522/ptj.20110414. Epub 2012 May 10. — View Citation

Cutler LR, Hayter M, Ryan T. A critical review and synthesis of qualitative research on patient experiences of critical illness. Intensive Crit Care Nurs. 2013 Jun;29(3):147-57. doi: 10.1016/j.iccn.2012.12.001. Epub 2013 Jan 9. Review. — View Citation

Jackson JC, Ely EW. Cognitive impairment after critical illness: etiologies, risk factors, and future directions. Semin Respir Crit Care Med. 2013 Apr;34(2):216-22. doi: 10.1055/s-0033-1342984. Epub 2013 May 28. — View Citation

Luke SG, Henderson JM. The Influence of Content Meaningfulness on Eye Movements across Tasks: Evidence from Scene Viewing and Reading. Front Psychol. 2016 Mar 1;7:257. doi: 10.3389/fpsyg.2016.00257. eCollection 2016. — View Citation

Needham DM, Dinglas VD, Bienvenu OJ, Colantuoni E, Wozniak AW, Rice TW, Hopkins RO; NIH NHLBI ARDS Network. One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial. BMJ. 2013 Mar 19;346:f1532. doi: 10.1136/bmj.f1532. — View 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. — View Citation

Wolters AE, Slooter AJ, van der Kooi AW, van Dijk D. Cognitive impairment after intensive care unit admission: a systematic review. Intensive Care Med. 2013 Mar;39(3):376-86. doi: 10.1007/s00134-012-2784-9. Epub 2013 Jan 18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention measurement in patients in the intensive care unit	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	Quality of Life	The quality of life are examined via EuroQol (EQ-5D-5L) questionnaire	After 3 months after admission to the ICU
Secondary	Cognitive functioning	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