EyeControl Communication Device for ICU Delirium

(EMERGE Trial)

Not currently recruiting at 3 trial locations

Overseen By Siddhartha R Janga, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Neuromuscular blockers

Disqualifiers: Advanced dementia, Neurological disorders, Psychiatric disorders, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the EyeControl-Pro device can reduce the occurrence and severity of delirium in intensive care unit (ICU) patients. Delirium, a sudden confusion, often affects critically ill patients on mechanical ventilation. The trial compares two groups: one using the EyeControl-Pro, which provides messages, music, and assessments, and a control group without these features. Patients on mechanical ventilation for at least 24 hours with certain alertness levels may qualify. As an unphased trial, this study allows patients to contribute to innovative research that could enhance ICU care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the EyeControl-Pro device is safe for ICU patients?

Research has shown that the EyeControl-Med device, similar to the EyeControl-Pro, is safe for use in the ICU. In earlier studies, this device helped patients communicate better and respond more effectively. A small initial study confirmed its safety and practicality for very sick patients. No serious side effects were reported from using the device. Overall, evidence suggests that the EyeControl-Pro is likely well-tolerated, based on the safety record of the EyeControl-Med. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EyeControl-Pro device because it offers a unique, tech-driven approach to managing ICU delirium. Unlike traditional treatments that rely on medication and environmental adjustments, EyeControl-Pro uses a non-invasive wearable device to deliver personalized family messages and re-orientation prompts, promoting engagement and awareness. It also integrates music or white/brown noise to soothe patients, which can be tailored to individual preferences. This innovative method aims to maintain cognitive function and reduce delirium by providing continuous, personalized auditory stimulation, setting it apart from standard care options.

What evidence suggests that the EyeControl-Pro device is effective for reducing ICU delirium?

Research has shown that the EyeControl-Med device, like the EyeControl-Pro, helps ICU patients communicate more effectively. Better communication may reduce the severity and duration of delirium, a condition where patients become confused and less aware of their surroundings. In this trial, participants in the EyeControl-Pro assisted active intervention arm will use the EyeControl-Pro device, which keeps patients engaged and aware by playing personalized messages and calming sounds. These features aim to maintain awareness and possibly prevent or reduce delirium symptoms. Meanwhile, the sham control arm will use an identical-appearing device without these interactive features. Studies have found that using these devices with critically ill patients can improve mental health, reducing anxiety and depression. ^{1 2 6 7 8}

Who Is on the Research Team?

Somnath Bose, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for critically ill patients aged 50 or older who are expected to need a ventilator for at least 24 hours and can respond minimally. They shouldn't be in another conflicting study, have severe cognitive impairments, uncorrected hearing or vision issues, or conditions limiting survival or care directives.

Inclusion Criteria

You are expected to need a ventilator for at least 24 hours.

Your RASS score is between -3 and +1.

I am 50 years or older and on a mechanical ventilator.

Exclusion Criteria

It is not expected that you will live for at least 24 hours.

Have severe uncorrected psychiatric disorders

Enrolled in a clinical trial which prohibits co-enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either the EyeControl-Pro device or a sham device for up to 7 days while in the ICU

7 days

Daily assessments (in-person)

Follow-up

Participants are monitored for cognitive function and anxiety/depression scores 30 days post-randomization

30 days

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• EyeControl-Pro

Trial Overview The EMERGE trial is testing if the EyeControl-Pro platform helps reduce how often and how severely delirium occurs in ICU patients when added to standard care. Patients will either use the new device (EyeControl-Pro) or receive usual care without it.

How Is the Trial Designed?

Group I: EyeControl-Pro assisted active intervention arm Active Control 1 Intervention

Participants 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.

Group II: Sham Control Placebo Group 1 Intervention

Participants 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.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Assuta Medical Center

Collaborator

Trials

43

Recruited

44,700+

Rabin Medical Center

Collaborator

Trials

423

Recruited

149,000+

BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency

Collaborator

Trials

1

Recruited

160+

Eyefree Assisting Communication Ltd

Industry Sponsor

Trials

3

Recruited

210+

Published Research Related to This Trial

In a pilot study involving 15 critically ill patients, the EyeControl-Med device significantly improved communication capabilities, as indicated by a mean increase of 19.3 points on the Loewenstein Communication Scale (p < 0.0001).

The use of the EyeControl-Med device also correlated with a reduction in delirium symptoms, with the mean number of errors on the CAM-ICU questionnaire decreasing from 6.5 to 2.5 (p = 0.0006), and no adverse effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The EyeControl-Med device, an alternative tool for communication in ventilated critically ill patients: A pilot study examining communication capabilities and delirium. Itai Bendavid, I., Assi, S., Sasson, N., et al.[2023]

In a study involving 44 mechanically ventilated patients, the high-tech eye tracking device significantly improved communication effectiveness compared to a conventional low-tech communication board, with patients transmitting a median of four messages per exchange versus two for the board.

The eye tracking device also had a higher success rate (100% vs. 80%) and greater patient satisfaction (52% satisfied and 48% very satisfied) compared to the board, indicating its potential to enhance patient-centered care in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of communication interfaces for mechanically ventilated patients in intensive care. Szymkowicz, E., Bodet-Contentin, L., Marechal, Y., et al.[2023]

This pilot study involving 20 intubated ICU patients suggests that the Deltascan single-channel EEG may provide additional insights into detecting delirium, although it did not show statistically significant agreement with the CAM-ICU assessment.

The Deltascan measurements showed a higher, yet not statistically significant, agreement with clinical diagnoses of delirium made by ICU physicians, indicating potential value for further research in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Deltascan Single Channel Electroencephalography (EEG), Confusion Assessment Method-Intensive Care Unit (CAM-ICU) Score and Clinical Assessment in Diagnosing Delirium in Intubated Patients in the Intensive Care Unit. Aben, J., Pouwels, S., Oldenbeuving, A.[2022]

The study involved 15 dysarthric ICU patients, 8 physicians, and 15 nurses, and found that using a gaze-controlled communication system (eye tracker) significantly improved communication between patients and medical staff across various domains, including understanding patient needs and clinical conditions.

Post-intervention results indicated a notable reduction in anxiety and frustration for both patients and healthcare providers, suggesting that enhanced communication can positively impact psychological well-being in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaze-controlled, computer-assisted communication in Intensive Care Unit: "speaking through the eyes". Maringelli, F., Brienza, N., Scorrano, F., et al.[2022]

In a pilot study involving 12 mechanically ventilated patients in a surgical ICU, both a communication board (CB) and an eye tracking device (ETD) were found to be equally effective in helping patients communicate their basic needs, achieving 100% accuracy.

A significant 83% of patients expressed a desire to communicate additional needs beyond basic questions, highlighting the importance of using assistive communication devices to uncover a wider range of patient concerns, including emotional and spiritual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study assessing the spiritual, emotional, physical/environmental, and physiological needs of mechanically ventilated surgical intensive care unit patients via eye tracking devices, head nodding, and communication boards. Duffy, EI., Garry, J., Talbot, L., et al.[2022]

Patients in the ICU who used eye-tracking devices were able to effectively communicate their basic needs, indicating that these devices can enhance communication in critical care settings.

The use of eye-tracking devices led to significant improvements in patients' psychosocial status, with a positive overall impact score on the Psychosocial Impact of Assistive Devices Scale (PIADS), suggesting potential benefits for patient outcomes in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of eye-tracking devices in intensive care. Garry, J., Casey, K., Cole, TK., et al.[2022]

In a study involving 11 mechanically ventilated patients, eye-tracking technology was successfully learned and used for communication within an average of 64 minutes, allowing patients to express their needs and answer questions about their condition.

All patients preferred the gaze fixation method over the wink control for operating the eye-tracking device, indicating a user-friendly approach that enhances communication and may improve rehabilitation outcomes by allowing for better detection of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experiences of communication with mechanically ventilated patients in the intensive care unit using eye-tracking technology. Ull, C., Weckwerth, C., Schildhauer, TA., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06029244

Study Details | NCT06029244 | Eyecontrol coMmunication ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883944123001004

The EyeControl-Med device, an alternative tool for ... The EyeControl-Med device may facilitate communication and reduce the manifestations and duration of delirium in ventilated critically ill patients.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37348187/

The EyeControl-Med device, an alternative tool for ... The EyeControl-Med device may facilitate communication and reduce the manifestations and duration of delirium in ventilated critically ill patients.

4. withpower.com withpower.com/trial/phase-delirium-9-2023-c6dc7

EyeControl Communication Device for ICU Delirium Research suggests that eye-tracking devices, like the EyeControl-Med, can improve communication for patients in the ICU who cannot speak, potentially reducing ...

5. researchgate.net researchgate.net/publication/366315965_124_THE_EYECONTROL-MED_DEVICE_IN_VENTILATED_ICU_PATIENTS_A_STUDY_OF_COMMUNICATION_AND_DELIRIUM

THE EYECONTROL-MED DEVICE IN VENTILATED ICU ... It frequently generates psychiatric and psychological outcomes such as depressed mood, anxiety and/or Post Traumatic Stress Disorder (PTSD).

6. journals.lww.com journals.lww.com/ccmjournal/fulltext/2023/01001/124__the_eyecontrol_med_device_in_ventilated_icu.91.aspx

124: the eyecontrol-med device in ventilated icu patients: a ... It may reduce the manifestations and duration of delirium in ventilated critically ill patients. Controlled studies are required to establish this effect.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0883944125002461

A pilot study to assess the safety and feasibility of ... This pilot study was aimed at demonstrating the safety and feasibility of deploying the EyeControl-Med device in critically ill patients. Methods. A prospective ...

8. ovid.com ovid.com/journals/jcrca/fulltext/10.1016/j.jcrc.2023.154351~the-eyecontrolmed-device-an-alternative-tool-for

The EyeControl-Med device, an alternative tool... Delirium was assessed using a computerized CAM-ICU questionnaire. Results: 15 patients were included, 40% of whom were diagnosed with COVID-19. All patients ...