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DeliriumEMERGENCT06029244

Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)

A study of Delirium and Delirium in Old Age, run by Beth Israel Deaconess Medical Center at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Delirium, Delirium in Old Age, Critical Illness
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
3 sitesin 2 countries
Study dates
25 Feb 2024to 18 Nov 2025
Phase
Interventional
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mechanically ventilated patients aged >=50 years
  • RASS score of -3 to +1 and
  • Anticipated to require >=24 hours of mechanical ventilation

Who cannot join

  • Not expected to survive >=24 hours
  • Have limitations in care (Do Not Resuscitate, or comfort-focused care orders)
  • Receiving paralytic neuromuscular blocking agent (NMBA) infusion or anticipated need for NMBA use
  • Have advanced dementia or cognitive impairment including post-concussive syndrome.
  • Have severe uncorrected psychiatric disorders.
  • Have uncorrected hearing or visual impairment.
Show all 12Show fewer
  • Acute or subacute neurological disorder hindering communication or ability to participate in CAM ICU assessments
  • Enrolled in a clinical trial which prohibits co-enrollment.
  • Incarcerated
  • Have no identified legally appointed representative (LAR)
  • Are unable to communicate in the predominant local language (English at US site and English/Hebrew/Arabic/Russian in Israel)
  • Refusal of treating clinical team.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Israel2 sites

  • Assuta Ashdod Medical Center

    Ashdod

  • Rabin Medical Center

    Petah Tikva

Other trials in Israel

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE) : A Multicenter Randomized Controlled Trial

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.

Read the detailed description

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.

Being tested
EyeControl-Pro, Control
Medical subject headings
Delirium, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EyeControl-ProDevice

    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

  • ControlOther

    No intervention

Study groups in NCT06029244
Study groupRoleWhat they receive
EyeControl-Pro assisted active intervention armActive comparatorParticipants will wear the EyeControl-Pro device daily from 08:00-18:00 (extendable to 20:00; minimum 4 hours for compliance). On Day 1, onboarding includes a ≤2 min auditory tutorial, repeated daily for orientation. The device delivers up to 5 personalized family messages and 5 automated re-orientation messages per day, alternating approximately every 2 hours to maintain engagement and awareness. Slow-tempo music or white/brown noise plays in 15-minute sessions every 4 hours, modulated according to the patient's preferences and responses. The device performs twice-daily automated CAM-ICU assessments, scheduled within 45 minutes of blinded assessor CAM-ICU to allow comparison. Study team delirium assessments occur twice daily through Day 7, then once daily if in ICU for days 8-14, with MoCA/t-MoCA and HADS at Day 30 (+14 day window). Device use ends after 7 days, earlier if extubated, discharged, transitioned to comfort care, or in the event of death.
Receives: Device: EyeControl-Pro
Sham ControlSham comparatorParticipants will wear an identical-appearing EyeControl device daily from 08:00-18:00 (extendable to 20:00; minimum 4 hours for compliance). On Day 1, onboarding includes a ≤2 min auditory tutorial introducing the device. No automated re-orientation messages, family messages, or music sessions are delivered. The device tracks eye state and logs activity but does not provide auditory feedback beyond the initial tutorial. Blinded study team members perform twice-daily CAM-ICU and CAM-ICU-7 assessments through Day 7, then once daily if in ICU for days 8-14. MoCA/t-MoCA and HADS assessments occur at Day 30 (+14 day window). Device is removed after 7 days, upon extubation, ICU discharge, comfort care transition, or death.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of any delirium occurrence defined as CAM ICU 7 score (>=2) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner)

    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 7 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.

    Measured: Upto 7 days or liberation from ventilator whichever is sooner.

Secondary outcomes (2)

  1. Prevalence of severe delirium assessments (defined as CAM ICU 7>=6) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner)

    To evaluate if study subjects in the active EyeControl-Pro arm have lower prevalence of severe delirium assessments 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.

    Measured: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner

  2. Mean number of days with delirium (defined as the total number of days with at least one CAM ICU 7 positive delirium assessment within 7 days post-randomization or up to discharge from the ICU/death, whatever occurs earlier.

    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.

    Measured: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start25 Feb 2024
  3. Primary completion20 Oct 2025
  4. Study completion18 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study participants will be randomized to either a) EyeControl-Pro assisted active intervention arm or b) sham control
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029244
Sponsor's protocol ID
2023P000563
Acronym
EMERGE
Status last verified
Nov 2025
First submitted
1 Sep 2023
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 18495054

  • 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.

    PubMed 32746469

  • 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.

    PubMed 15082703

  • 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.

    PubMed 11797025

  • 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.

    PubMed 24088092

  • 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.

    PubMed 15071384

  • 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.

    PubMed 27965224

  • 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.

    PubMed 33480183

  • 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.

    PubMed 27748656

  • 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.

    PubMed 33428871

  • 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.

    PubMed 31476770

  • 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.

    PubMed 27004732

Questions about this trial

What is this clinical trial studying?

A study of Delirium and Delirium in Old Age, run by Beth Israel Deaconess Medical Center at 3 sites in 2 countries.

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 3 inclusion and 12 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel, United States. 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. Some participants in this study may receive a placebo. 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?

Prevalence of any delirium occurrence defined as CAM ICU 7 score (>=2) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner) (time frame: Upto 7 days or liberation from ventilator whichever is sooner.). 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 NCT06029244, which also lists 12 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 Dec 2025.

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