Cognitive Impairment, MildNCT03025373
Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients
An observational study of Cognitive Impairment, Mild and Quality of Life, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Mild, Quality of Life
- What is being tested?
- Visuo-acoustic stimulation
- How many people
- 67 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2017to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consist of adults on the intensive care unit
Who may be able to join
- Age > =18
- Speak German or French
- Are able to participate the follow up measurements
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsklinik für Intensivmedizin, Inselspital
Bern, 3010
About this study
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.
- Conditions
- Cognitive Impairment, Mild, Quality of Life
- Being tested
- Visuo-acoustic stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuo-acoustic stimulationOther
Controlled visual and acoustic stimulation in a virtual reality setting
| Study group | Role | What they receive |
|---|---|---|
| Patients - prolonged ICU stay (> 5 days) | Controlled visual and acoustic stimulation in a virtual reality setting Receives: Other: Visuo-acoustic stimulation | |
| Heart surgery patients (< 5 days) | Controlled visual and acoustic stimulation in a virtual reality setting Receives: Other: Visuo-acoustic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline in attention measurement during and after admission (3 Month) to the ICU
Secondary outcomes (2)
Quality of Life
The quality of life are examined via EuroQol (EQ-5D-5L) questionnaire
Measured: After 3 months after admission to the ICU
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)
Measured: Changes from baseline in cognitive functioning measurement after admission (3 Month) to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Nov 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Marie- Madlen Jeitziner, Dr., Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025373
- Sponsor's protocol ID
- 2016-01652
- Other IDs
- 2016
- Status last verified
- May 2019
- First submitted
- 16 Jan 2017
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22577067Brummel 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.
PubMed 24257969Cutler 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.
PubMed 23312486Jackson 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.
PubMed 23716312Luke 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.
PubMed 26973561Needham 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.
PubMed 23512759Pandharipande 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.
PubMed 24088092Wolters 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.
PubMed 23328935
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT03025373
- Acronym / sponsor ID
- 2016-01652
- Conditions
- Cognitive Impairment, Mild, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients - prolonged ICU stay (> 5 days) | – | Other: Visuo-acoustic stimulationControlled visual and acoustic stimulation in a virtual reality setting |
| Heart surgery patients (< 5 days) | – | Other: Visuo-acoustic stimulationControlled visual and acoustic stimulation in a virtual reality setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consist of adults on the intensive care unit
Key inclusion criteria (4 listed)
- Age > =18
- Speak German or French
- Are able to participate the follow up measurements
- Written informed consent
Key exclusion criteria (6 listed)
- Visual impairments
- Cognitive impairments
- Cognitive impairments
- Craniocerebral injury before admitting the ICU
- Already admitted the intensive care unit (last year) or at reentry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visuo-acoustic stimulationControlled visual and acoustic stimulation in a virtual reality setting | Other | Heart surgery patients (< 5 days), Patients - prolonged ICU stay (> 5 days) |
Primary outcome
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.
2 secondary outcomes
Quality of Life
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Background: PubMed 22577067Brummel 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.
- Background: PubMed 24257969Brummel 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.
- Background: PubMed 23312486Cutler 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.
- Background: PubMed 23716312Jackson 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.
- Background: PubMed 26973561Luke 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.
- Background: PubMed 23512759Needham 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.
- Background: PubMed 24088092Pandharipande 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.
- Background: PubMed 23328935Wolters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie- Madlen Jeitziner, Dr. study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, Mild and Quality of Life, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03025373, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.