<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03025373</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01652</org_study_id>
    <nct_id>NCT03025373</nct_id>
  </id_info>
  <brief_title>Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients</brief_title>
  <official_title>Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational study will be conducted in the ICU (Intensive care unit) including patients&#xD;
      with heart surgery (&lt; 5 days) and prolonged ICU stay (&gt; 5 days). Patients will receive 5 min&#xD;
      Virtual reality stimulation per day. A modified version of the Oculus Rift VR glasses&#xD;
      (Facebook inc., USA) with stereoscopic vision and stereo sound will be used to present the&#xD;
      virtual world to patients. An integrated eye tracker will measure oculomotor responses that&#xD;
      will be synchronized with the physiological data recording. All participants will undergo&#xD;
      neuropsychological testing after ICU stay, and after a three-months follow-up. Quality of&#xD;
      life prior to the ICU stay will be enquired from relatives. Main outcome variable is the&#xD;
      explorative behaviour (attention). Secondary outcomes are the quality of life and cognitive&#xD;
      functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Attention measurement in patients in the intensive care unit</measure>
    <time_frame>Changes from baseline in attention measurement during and after admission (3 Month) to the ICU</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>After 3 months after admission to the ICU</time_frame>
    <description>The quality of life are examined via EuroQol (EQ-5D-5L) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning</measure>
    <time_frame>Changes from baseline in cognitive functioning measurement after admission (3 Month) to the ICU</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Cognitive Impairment, Mild</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Patients - prolonged ICU stay (&gt; 5 days)</arm_group_label>
    <description>Controlled visual and acoustic stimulation in a virtual reality setting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart surgery patients (&lt; 5 days)</arm_group_label>
    <description>Controlled visual and acoustic stimulation in a virtual reality setting</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Visuo-acoustic stimulation</intervention_name>
    <description>Controlled visual and acoustic stimulation in a virtual reality setting</description>
    <arm_group_label>Heart surgery patients (&lt; 5 days)</arm_group_label>
    <arm_group_label>Patients - prolonged ICU stay (&gt; 5 days)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consist of adults on the intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; =18&#xD;
&#xD;
          -  Speak German or French&#xD;
&#xD;
          -  Are able to participate the follow up measurements&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visual impairments&#xD;
&#xD;
          -  Cognitive impairments&#xD;
&#xD;
          -  Cognitive impairments&#xD;
&#xD;
          -  Craniocerebral injury before admitting the ICU&#xD;
&#xD;
          -  Already admitted the intensive care unit (last year) or at reentry&#xD;
&#xD;
          -  Psychotic disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie- Madlen Jeitziner, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University hospital of Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinik für Intensivmedizin, Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>22577067</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24257969</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23312486</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23716312</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26973561</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23512759</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24088092</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23328935</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03025373
org study id: 2016-01652
nct id: NCT03025373
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Case-Control
time perspective: Prospective
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
description: 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.
measure: Quality of Life
time frame: After 3 months after admission to the ICU
description: The quality of life are examined via EuroQol (EQ-5D-5L) questionnaire
measure: Cognitive functioning
time frame: Changes from baseline in cognitive functioning measurement after admission (3 Month) to the ICU
description: 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)
arm group label: Patients - prolonged ICU stay (> 5 days)
description: Controlled visual and acoustic stimulation in a virtual reality setting
arm group label: Heart surgery patients (< 5 days)
description: Controlled visual and acoustic stimulation in a virtual reality setting
intervention type: Other
intervention name: Visuo-acoustic stimulation
description: Controlled visual and acoustic stimulation in a virtual reality setting
arm group label: Heart surgery patients (< 5 days)
arm group label: Patients - prolonged ICU stay (> 5 days)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marie- Madlen Jeitziner, Dr.
role: Study Chair
affiliation: University hospital of Bern
facility: 
country: Switzerland
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.
PMID: 22577067
citation: 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.
PMID: 24257969
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.
PMID: 23312486
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.
PMID: 23716312
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.
PMID: 26973561
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.
PMID: 23512759
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.
PMID: 24088092
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.
PMID: 23328935
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No