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

NCT ID: NCT03025373

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-04-01

Brief Summary

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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

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Conditions

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Cognitive Impairment, Mild Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients - prolonged ICU stay (> 5 days)

Controlled visual and acoustic stimulation in a virtual reality setting

Visuo-acoustic stimulation

Intervention Type OTHER

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

Visuo-acoustic stimulation

Intervention Type OTHER

Controlled visual and acoustic stimulation in a virtual reality setting

Interventions

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Visuo-acoustic stimulation

Controlled visual and acoustic stimulation in a virtual reality setting

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie- Madlen Jeitziner, Dr.

Role: STUDY_CHAIR

University hospital of Bern

Locations

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Universitätsklinik für Intensivmedizin, Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 22577067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24257969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23312486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23716312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26973561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23512759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24088092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23328935 (View on PubMed)

Other Identifiers

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2016-01652

Identifier Type: -

Identifier Source: org_study_id

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