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Eye-Tracking gadget aims to clear confusion in ICU patients

NCT ID NCT06029244

Symptom relief Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a wearable eye-tracking device called EyeControl-Pro in 160 older, ventilated ICU patients. The device lets patients communicate by moving their eyes, which may help reduce delirium—a state of confusion common in intensive care. Researchers compared patients who used the device to those who did not, checking for delirium over the first week.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EyeControl-Pro wearable eye-tracking device
What this could lead to
If it works, this device could help reduce confusion and distress in ICU patients who cannot speak, improving their recovery.
What could go wrong
This is a small, completed trial with 160 patients. The device may not significantly reduce delirium, and results may not apply to all ICU settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

160 people

The number who actually took part.

Started

Feb 2024

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Mechanically ventilated patients aged \>=50 years * RASS score of -3 to +1 and * Anticipated to require \>=24 hours of mechanical ventilation Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

Critical Illness delirium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Delirium Delirium in old age Intensive care unit delirium

Contacts and locations

Locations

  • Assuta Ashdod Medical Center

    Ashdod, Israel

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Rabin Medical Center

    Petah Tikva, Israel

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