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Eye-Tracking device could give voice to silent ICU patients

NCT ID NCT07205419

Symptom relief Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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)

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Expanded access (paused)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests whether an eye-tracking communication tool can help conscious ICU patients who cannot speak due to breathing tubes or injuries. Forty participants will use the device for two days, and researchers will compare their communication ease to standard methods like writing boards. The goal is to see if the tool is feasible and helpful in real hospital settings.

What this could mean

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

Active substance
Eye-tracking communication tool
What this could lead to
If it works, this could provide a practical way for non-verbal ICU patients to communicate their needs and feelings more easily.
What could go wrong
This is a small, early feasibility study with only 40 participants, so results may not apply widely. The tool may not work for all patients or may be difficult to use in busy 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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

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

18 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.

ICU patient Inclusion Criteria: * aged ≥ 18 years * unable to communicate through normal verbal means due to endotracheal intubation/tracheotomy, muscle or nerve injury, acute/chronic spinal cord injury, etc. * Richmond Agitation-Sedation Scale (RASS) score ranging from -1 to 1 * able to comply with simple instructions for study participation Exclusion Criteria: * blindness or inability to elevate the eyelids that preclude successful participation in eye-tracking interaction tasks * cognitive impairment limiting meaningful participation * severe psychological distress Family members Inclusion Criteria: * aged ≥ 18 years * had visitation experiences during the patient's ICU admission Exclusion Criteria: * cognitive impairment * severe psychological distress ICU nurses/physicians Inclusion Criteria: * aged ≥ 18 years * registered nurses/physicians employed in the study hospital * regularly involved in direct ICU care * at least one year of ICU work experience Exclusion Criteria: * primarily involved in administrative work * internship or trainee role without regular independent patient care

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As listed by the trial registrant

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

Communication barriers Eye-tracking technology Icu patients

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