xml: <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/NCT06029244</url>
    </required_header>
    <id_info>
      <org_study_id>2023P000563</org_study_id>
      <nct_id>NCT06029244</nct_id>
    </id_info>
    <brief_title>Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)</brief_title>
    <acronym>EMERGE</acronym>
    <official_title>Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE) : A Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beth Israel Deaconess Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rabin Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Assuta Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Eyefree Assisting Communication Ltd</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Beth Israel Deaconess Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research is to investigate whether addition of the EyeControl-Pro&#xD;
        platform as an adjunct to standard guideline-based intensive care unit management of&#xD;
        critically ill patients is effective in reducing delirium incidence and severity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, binational, single-blind, multicenter, randomized control trial,&#xD;
        conducted according to international good clinical practice (GCP) ethical and quality&#xD;
        standards. Critically ill, mechanically ventilated patients aged &gt;=50 years with Richmond&#xD;
        Agitation Sedation Scale (RASS) score of -3 to +1 (at time of screening) who are anticipated&#xD;
        to require ventilation for &gt;=24 hours will be eligible for recruitment. The study will be&#xD;
        conducted simultaneously at Beth Israel Deaconess Medical Center (BIDMC) Boston, USA, Assuta&#xD;
        Ashdod Medical Center (Ashdod, Israel) and Rabin Medical Center (Petah Tikvah, Israel) with&#xD;
        BIDMC contributing up to 50% of the total enrollment. Participants will be randomized to&#xD;
        either a) sham device or b) active intervention arm (details described below). Legally&#xD;
        appointed representatives, patients and caregiver teams will be administered an optional&#xD;
        questionnaire to assess their experience with the study device at the conclusion of the study&#xD;
        protocol. Study subjects will be administered the telephone-Montreal Cognitive Assessment&#xD;
        (t-MoCA); total score of 22 - missing 8 points present in Montreal Cognitive Assessment&#xD;
        (MoCA) pertaining to drawing/executive function not feasible over phone) or MoCA (if still&#xD;
        in-hospital; assessed out of total score of 30) and Hospital Anxiety and Depression Scale&#xD;
        (HADS) questionnaire 30 days post-randomization. Hebrew versions of these questionnaires will&#xD;
        be used at Israeli sites.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Study participants will be randomized to either a) EyeControl-Pro assisted active intervention arm or b) sham control</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Patients will be unblinded, or unmasked, to treatment allocation given the nature of the intervention.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of delirium free assessments as assessed by Confusion Assessment Method (CAM)</measure>
      <time_frame>Upto 7 days or liberation from ventilator whichever is sooner.</time_frame>
      <description>To evaluate if study subjects randomized to active EyeControl-Pro arm have a higher proportion of delirium free assessments as assessed by CAM (confusion assessment method)-ICU during device usage for up to 7 days when compared with those in the sham EyeControl-Pro arm. CAM-ICU is a validated assessment tool for detection of ICU delirium which provides a binary response delirium present or not.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Delirium severity as measured by Confusion Assessment Method Intensive Care Unit-7(CAM-ICU7)</measure>
      <time_frame>Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner</time_frame>
      <description>To evaluate if study subjects in the active EyeControl-Pro arm have lower delirium severity as measured by CAM-ICU7 within first 7 days post randomization or ICU discharge (whichever is sooner) when compared to sham control arm. CAM-ICU 7 is a validated instrument for measurement of delirium severity with scores ranging from 0-7. 0 indicating no delirium to 7 (severe delirium)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delirium incidence</measure>
      <time_frame>Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner</time_frame>
      <description>To evaluate if subjects randomized to the active EyeControl-Pro arm have lower delirium incidence (as measured by CAM-ICU) within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm. The CAM-ICU generates a score of 0-4. 0 being no delirium, 4 being severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU days alive and free of delirium and coma</measure>
      <time_frame>Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner</time_frame>
      <description>To evaluate if subjects randomized to the active EyeControl-Pro arm have higher number of days free of coma and delirium within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Cognitive scores</measure>
      <time_frame>30 days post-randomization.</time_frame>
      <description>To compare cognitive function at 30 days post enrollment using the t-MoCA (telephone-Montreal Cognitive Assessment) or MoCA (if still in-hospital) questionnaire. MoCA is a validated instrument for assessment of cognition with range 0-30 (0-22 for telephonic version) score of over 26 indicates normal.</description>
    </other_outcome>
    <other_outcome>
      <measure>Depression anxiety scores</measure>
      <time_frame>30 days post-randomization.</time_frame>
      <description>To compare depression and anxiety scores at 30 days post enrollment using the HADS (Hospital Anxiety and Depression Scale) questionnaire.HADS ranges from 0-21 with higher scores indicating worse depression or anxiety</description>
    </other_outcome>
    <other_outcome>
      <measure>CAM ICU concordance</measure>
      <time_frame>During device usage upto 7 days</time_frame>
      <description>Agreement between CAM ICU assessment between Eyecontrol and investigator administered CAM-ICU in active intervention arm</description>
    </other_outcome>
    <other_outcome>
      <measure>Cumulative dose of sedatives</measure>
      <time_frame>During device usage or upto 7 days whichever is sooner</time_frame>
      <description>Dose of intravenous sedatives between 2 groups (in mgs/mcgs)</description>
    </other_outcome>
    <other_outcome>
      <measure>Days free of restraints</measure>
      <time_frame>Upto 7 days or discharge from intensive care unit</time_frame>
      <description>Comparison of days free of restraints between 2 groups</description>
    </other_outcome>
    <other_outcome>
      <measure>Use of rescue medications for delirium and agitation</measure>
      <time_frame>Upto 7 days or discharge from intensive care unit</time_frame>
      <description>Use of medications for agitated delirium</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Delirium</condition>
    <condition>Delirium in Old Age</condition>
    <condition>Critical Illness</condition>
    <condition>Intensive Care Unit Delirium</condition>
    <arm_group>
      <arm_group_label>EyeControl-Pro assisted active intervention arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Personalized family messages recorded by LARs or others will be played at regular intervals up to 5 times per day (between 08:00-18:00) (8 am to 6 pm). Personalized music/brown noise will be played for 15 minutes every 4 hours, which will be modulated according to your reactions/choices. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Control</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Patient's will not receive any of the orientation or family messages and no music will be played through the earphones of the device. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EyeControl-Pro</intervention_name>
      <description>Based on artificial intelligence (AI)-powered eye-tracking technology, the EyeControl-Pro wearable device and smart platform enable 24/7 customizable communication and monitoring between ventilated patients who cannot speak, their families, and medical teams</description>
      <arm_group_label>EyeControl-Pro assisted active intervention arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>No intervention</description>
      <arm_group_label>Sham Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mechanically ventilated patients aged &gt;=50 years&#xD;
  &#xD;
            -  RASS score of -3 to +1 and&#xD;
  &#xD;
            -  Anticipated to require &gt;=24 hours of mechanical ventilation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not expected to survive &gt;=24 hours&#xD;
  &#xD;
            -  Have limitations in care (Do Not Resuscitate, or comfort-focused care orders)&#xD;
  &#xD;
            -  Receiving paralytic neuromuscular blocking agent (NMBA) infusion or anticipated need&#xD;
               for NMBA use&#xD;
  &#xD;
            -  Have advanced dementia or cognitive impairment including post-concussive syndrome.&#xD;
  &#xD;
            -  Have acute or subacute neurological disorders.&#xD;
  &#xD;
            -  Have severe uncorrected psychiatric disorders.&#xD;
  &#xD;
            -  Have uncorrected hearing or visual impairment.&#xD;
  &#xD;
            -  Have an unstable cervical spine or collar in place limiting movement.&#xD;
  &#xD;
            -  Enrolled in a clinical trial which prohibits co-enrollment.&#xD;
  &#xD;
            -  Incarcerated&#xD;
  &#xD;
            -  Have no identified legally appointed representative (LAR)&#xD;
  &#xD;
            -  Are unable to communicate in the predominant local language (English at US site and&#xD;
               Hebrew in Israel)&#xD;
  &#xD;
            -  Refusal of treating clinical team.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Somnath Bose, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beth Israel Deaconess Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alkanada Behera</last_name>
      <phone>617-667-7000</phone>
      <email>abehera@bidmc.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Evynne Gartner, BA</last_name>
      <phone>617-632-8065</phone>
      <email>egartner@bidmc.harvard.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Beth Israel Deaconess Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Somnath Bose, MD</last_name>
        <phone>617-667-7000</phone>
        <email>sbose2@bidmc.harvard.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Assuta Ashdod Medical Center</name>
        <address>
          <city>Ashdod</city>
          <country>Israel</country>
        </address>
      </facility>
      <contact>
        <last_name>Ami Mayo, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rabin Medical Center</name>
        <address>
          <city>Petah tikva</city>
          <country>Israel</country>
        </address>
      </facility>
      <contact>
        <last_name>Itai Ben David, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.</citation>
      <PMID>18495054</PMID>
    </reference>
    <reference>
      <citation>Mart MF, Williams Roberson S, Salas B, Pandharipande PP, Ely EW. Prevention and Management of Delirium in the Intensive Care Unit. Semin Respir Crit Care Med. 2021 Feb;42(1):112-126. doi: 10.1055/s-0040-1710572. Epub 2020 Aug 3.</citation>
      <PMID>32746469</PMID>
    </reference>
    <reference>
      <citation>Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.</citation>
      <PMID>15082703</PMID>
    </reference>
    <reference>
      <citation>Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.</citation>
      <PMID>11797025</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>Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.</citation>
      <PMID>15071384</PMID>
    </reference>
    <reference>
      <citation>Smith CD, Grami P. Feasibility and Effectiveness of a Delirium Prevention Bundle in Critically Ill Patients. Am J Crit Care. 2016 Dec;26(1):19-27. doi: 10.4037/ajcc2017374.</citation>
      <PMID>27965224</PMID>
    </reference>
    <reference>
      <citation>Kinchin I, Mitchell E, Agar M, Trepel D. The economic cost of delirium: A systematic review and quality assessment. Alzheimers Dement. 2021 Jun;17(6):1026-1041. doi: 10.1002/alz.12262. Epub 2021 Jan 21.</citation>
      <PMID>33480183</PMID>
    </reference>
    <reference>
      <citation>Hayhurst CJ, Pandharipande PP, Hughes CG. Intensive Care Unit Delirium: A Review of Diagnosis, Prevention, and Treatment. Anesthesiology. 2016 Dec;125(6):1229-1241. doi: 10.1097/ALN.0000000000001378.</citation>
      <PMID>27748656</PMID>
    </reference>
    <reference>
      <citation>Pun BT, Badenes R, Heras La Calle G, Orun OM, Chen W, Raman R, Simpson BK, Wilson-Linville S, Hinojal Olmedillo B, Vallejo de la Cueva A, van der Jagt M, Navarro Casado R, Leal Sanz P, Orhun G, Ferrer Gomez C, Nunez Vazquez K, Pineiro Otero P, Taccone FS, Gallego Curto E, Caricato A, Woien H, Lacave G, O'Neal HR Jr, Peterson SJ, Brummel NE, Girard TD, Ely EW, Pandharipande PP; COVID-19 Intensive Care International Study Group. Prevalence and risk factors for delirium in critically ill patients with COVID-19 (COVID-D): a multicentre cohort study. Lancet Respir Med. 2021 Mar;9(3):239-250. doi: 10.1016/S2213-2600(20)30552-X. Epub 2021 Jan 8. Erratum In: Lancet Respir Med. 2021 Jan 27;:</citation>
      <PMID>33428871</PMID>
    </reference>
    <reference>
      <citation>Nikooie R, Neufeld KJ, Oh ES, Wilson LM, Zhang A, Robinson KA, Needham DM. Antipsychotics for Treating Delirium in Hospitalized Adults: A Systematic Review. Ann Intern Med. 2019 Oct 1;171(7):485-495. doi: 10.7326/M19-1860. Epub 2019 Sep 3.</citation>
      <PMID>31476770</PMID>
    </reference>
    <reference>
      <citation>Neufeld KJ, Yue J, Robinson TN, Inouye SK, Needham DM. Antipsychotic Medication for Prevention and Treatment of Delirium in Hospitalized Adults: A Systematic Review and Meta-Analysis. J Am Geriatr Soc. 2016 Apr;64(4):705-14. doi: 10.1111/jgs.14076. Epub 2016 Mar 23. Erratum In: J Am Geriatr Soc. 2016 Oct;64(10 ):2171-2173.</citation>
      <PMID>27004732</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
      <investigator_full_name>Somnath Bose, MD</investigator_full_name>
      <investigator_title>Assistant Professor of Anesthesia, Harvard Medical School</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delirium</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029244
  org study id: 2023P000563
  nct id: NCT06029244
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this research is to investigate whether addition of the EyeControl-Pro
        platform as an adjunct to standard guideline-based intensive care unit management of
        critically ill patients is effective in reducing delirium incidence and severity.
  This is a prospective, binational, single-blind, multicenter, randomized control trial,
        conducted according to international good clinical practice (GCP) ethical and quality
        standards. Critically ill, mechanically ventilated patients aged >=50 years with Richmond
        Agitation Sedation Scale (RASS) score of -3 to +1 (at time of screening) who are anticipated
        to require ventilation for >=24 hours will be eligible for recruitment. The study will be
        conducted simultaneously at Beth Israel Deaconess Medical Center (BIDMC) Boston, USA, Assuta
        Ashdod Medical Center (Ashdod, Israel) and Rabin Medical Center (Petah Tikvah, Israel) with
        BIDMC contributing up to 50% of the total enrollment. Participants will be randomized to
        either a) sham device or b) active intervention arm (details described below). Legally
        appointed representatives, patients and caregiver teams will be administered an optional
        questionnaire to assess their experience with the study device at the conclusion of the study
        protocol. Study subjects will be administered the telephone-Montreal Cognitive Assessment
        (t-MoCA); total score of 22 - missing 8 points present in Montreal Cognitive Assessment
        (MoCA) pertaining to drawing/executive function not feasible over phone) or MoCA (if still
        in-hospital; assessed out of total score of 30) and Hospital Anxiety and Depression Scale
        (HADS) questionnaire 30 days post-randomization. Hebrew versions of these questionnaires will
        be used at Israeli sites.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Study participants will be randomized to either a) EyeControl-Pro assisted active intervention arm or b) sham control
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Patients will be unblinded, or unmasked, to treatment allocation given the nature of the intervention.
  measure: Proportion of delirium free assessments as assessed by Confusion Assessment Method (CAM)
  time frame: Upto 7 days or liberation from ventilator whichever is sooner.
  description: To evaluate if study subjects randomized to active EyeControl-Pro arm have a higher proportion of delirium free assessments as assessed by CAM (confusion assessment method)-ICU during device usage for up to 7 days when compared with those in the sham EyeControl-Pro arm. CAM-ICU is a validated assessment tool for detection of ICU delirium which provides a binary response delirium present or not.
  measure: Delirium severity as measured by Confusion Assessment Method Intensive Care Unit-7(CAM-ICU7)
  time frame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
  description: To evaluate if study subjects in the active EyeControl-Pro arm have lower delirium severity as measured by CAM-ICU7 within first 7 days post randomization or ICU discharge (whichever is sooner) when compared to sham control arm. CAM-ICU 7 is a validated instrument for measurement of delirium severity with scores ranging from 0-7. 0 indicating no delirium to 7 (severe delirium)
  measure: Delirium incidence
  time frame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
  description: To evaluate if subjects randomized to the active EyeControl-Pro arm have lower delirium incidence (as measured by CAM-ICU) within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm. The CAM-ICU generates a score of 0-4. 0 being no delirium, 4 being severe.
  measure: ICU days alive and free of delirium and coma
  time frame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
  description: To evaluate if subjects randomized to the active EyeControl-Pro arm have higher number of days free of coma and delirium within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm
  measure: Cognitive scores
  time frame: 30 days post-randomization.
  description: To compare cognitive function at 30 days post enrollment using the t-MoCA (telephone-Montreal Cognitive Assessment) or MoCA (if still in-hospital) questionnaire. MoCA is a validated instrument for assessment of cognition with range 0-30 (0-22 for telephonic version) score of over 26 indicates normal.
  measure: Depression anxiety scores
  time frame: 30 days post-randomization.
  description: To compare depression and anxiety scores at 30 days post enrollment using the HADS (Hospital Anxiety and Depression Scale) questionnaire.HADS ranges from 0-21 with higher scores indicating worse depression or anxiety
  measure: CAM ICU concordance
  time frame: During device usage upto 7 days
  description: Agreement between CAM ICU assessment between Eyecontrol and investigator administered CAM-ICU in active intervention arm
  measure: Cumulative dose of sedatives
  time frame: During device usage or upto 7 days whichever is sooner
  description: Dose of intravenous sedatives between 2 groups (in mgs/mcgs)
  measure: Days free of restraints
  time frame: Upto 7 days or discharge from intensive care unit
  description: Comparison of days free of restraints between 2 groups
  measure: Use of rescue medications for delirium and agitation
  time frame: Upto 7 days or discharge from intensive care unit
  description: Use of medications for agitated delirium
  arm group label: EyeControl-Pro assisted active intervention arm
  arm group type: Active Comparator
  description: The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Personalized family messages recorded by LARs or others will be played at regular intervals up to 5 times per day (between 08:00-18:00) (8 am to 6 pm). Personalized music/brown noise will be played for 15 minutes every 4 hours, which will be modulated according to your reactions/choices. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.
  arm group label: Sham Control
  arm group type: Sham Comparator
  description: The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Patient's will not receive any of the orientation or family messages and no music will be played through the earphones of the device. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.
  intervention type: Device
  intervention name: EyeControl-Pro
  description: Based on artificial intelligence (AI)-powered eye-tracking technology, the EyeControl-Pro wearable device and smart platform enable 24/7 customizable communication and monitoring between ventilated patients who cannot speak, their families, and medical teams
  arm group label: EyeControl-Pro assisted active intervention arm
  intervention type: Other
  intervention name: Control
  description: No intervention
  arm group label: Sham Control
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Somnath Bose, MD
  role: Principal Investigator
  affiliation: Beth Israel Deaconess Medical Center
  last name: Alkanada Behera
  phone: 617-667-7000
  email: abehera@bidmc.harvard.edu
  last name: Evynne Gartner, BA
  phone: 617-632-8065
  email: egartner@bidmc.harvard.edu
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: Israel
  country: United States
  citation: Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
  PMID: 18495054
  citation: Mart MF, Williams Roberson S, Salas B, Pandharipande PP, Ely EW. Prevention and Management of Delirium in the Intensive Care Unit. Semin Respir Crit Care Med. 2021 Feb;42(1):112-126. doi: 10.1055/s-0040-1710572. Epub 2020 Aug 3.
  PMID: 32746469
  citation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
  PMID: 15082703
  citation: Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
  PMID: 11797025
  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: Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
  PMID: 15071384
  citation: Smith CD, Grami P. Feasibility and Effectiveness of a Delirium Prevention Bundle in Critically Ill Patients. Am J Crit Care. 2016 Dec;26(1):19-27. doi: 10.4037/ajcc2017374.
  PMID: 27965224
  citation: Kinchin I, Mitchell E, Agar M, Trepel D. The economic cost of delirium: A systematic review and quality assessment. Alzheimers Dement. 2021 Jun;17(6):1026-1041. doi: 10.1002/alz.12262. Epub 2021 Jan 21.
  PMID: 33480183
  citation: Hayhurst CJ, Pandharipande PP, Hughes CG. Intensive Care Unit Delirium: A Review of Diagnosis, Prevention, and Treatment. Anesthesiology. 2016 Dec;125(6):1229-1241. doi: 10.1097/ALN.0000000000001378.
  PMID: 27748656
  citation: Pun BT, Badenes R, Heras La Calle G, Orun OM, Chen W, Raman R, Simpson BK, Wilson-Linville S, Hinojal Olmedillo B, Vallejo de la Cueva A, van der Jagt M, Navarro Casado R, Leal Sanz P, Orhun G, Ferrer Gomez C, Nunez Vazquez K, Pineiro Otero P, Taccone FS, Gallego Curto E, Caricato A, Woien H, Lacave G, O'Neal HR Jr, Peterson SJ, Brummel NE, Girard TD, Ely EW, Pandharipande PP; COVID-19 Intensive Care International Study Group. Prevalence and risk factors for delirium in critically ill patients with COVID-19 (COVID-D): a multicentre cohort study. Lancet Respir Med. 2021 Mar;9(3):239-250. doi: 10.1016/S2213-2600(20)30552-X. Epub 2021 Jan 8. Erratum In: Lancet Respir Med. 2021 Jan 27;:
  PMID: 33428871
  citation: Nikooie R, Neufeld KJ, Oh ES, Wilson LM, Zhang A, Robinson KA, Needham DM. Antipsychotics for Treating Delirium in Hospitalized Adults: A Systematic Review. Ann Intern Med. 2019 Oct 1;171(7):485-495. doi: 10.7326/M19-1860. Epub 2019 Sep 3.
  PMID: 31476770
  citation: Neufeld KJ, Yue J, Robinson TN, Inouye SK, Needham DM. Antipsychotic Medication for Prevention and Treatment of Delirium in Hospitalized Adults: A Systematic Review and Meta-Analysis. J Am Geriatr Soc. 2016 Apr;64(4):705-14. doi: 10.1111/jgs.14076. Epub 2016 Mar 23. Erratum In: J Am Geriatr Soc. 2016 Oct;64(10 ):2171-2173.
  PMID: 27004732
  responsible party type: Principal Investigator
  investigator affiliation: Beth Israel Deaconess Medical Center
  investigator full name: Somnath Bose, MD
  investigator title: Assistant Professor of Anesthesia, Harvard Medical School
  mesh term: Delirium
  mesh term: Critical Illness
  sharing ipd: No