Eye TrackingNCT07429695
Eye-Tracking Interactive Agent in Non-verbal ICU Patients
A study testing eye-tracking interactive agent and conventional techniques in people with Eye Tracking and ICU, run by Shanghai Zhongshan Hospital.
Trial summary
The goal of this clinical trial is to determine whether an eye-tracking interactive agent can ameliorate communication impairments and reduce the incidence of complications among non-verbal patients in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Tracking, ICU, Communication Barriers
- What is being tested?
- eye-tracking interactive agent and conventional techniques
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Patients in the ICU who are 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 of -1 to 1
- Primary caregivers are adults
- Able to read Chinese characters and follow simple commands
- Willing to participate in this study.
Who cannot join
- Diseases associated with cognitive impairment, such as pulmonary encephalopathy, hepatic encephalopathy, diabetic hyperosmolar coma, and coma of unknown cause
- A history of mental disorders, dementia or pre-dementia, or intellectual disability
- Conditions precluding cooperation with eye-tracking interaction, such as blindness or inability to elevate the eyelids.
About this study
Official title: Eye-Tracking Interactive Agent in Non-verbal ICU Patients: A Study Protocol of a Randomized Controlled Trial With an Embedded Qualitative Study
The goal of this clinical trial is to determine whether an eye-tracking interactive agent can ameliorate communication impairments and reduce the incidence of complications among non-verbal patients in the intensive care unit (ICU). The main questions it aims to answer are:
Does the eye tracking interactive agent alleviate communication impairments among non-verbal patients in the ICU? Does the eye tracking interactive agent improve communication efficiency among non-verbal patients in the ICU? Does the eye tracking interactive agent m reduce the incidence of negative emotions among non-verbal patients in the ICU? Does the eye tracking interactive agent shorten the ICU length of stay for non-verbal patients in the ICU? Does the eye tracking interactive agent reduce the dosage of analgesic and sedative medications for non-verbal patients in the ICU? Does the eye tracking interactive agent improve family satisfaction for non-verbal patients in the ICU? Does the eye tracking interactive agent alleviate nurses' communication burden among non-verbal patients in the ICU? Researchers will compare eye tracking interactive agent to conventional techniques to see if e eye tracking interactive agent works to alleviate communication impairments.
Read more
Participants will:
Use an eye tracking interactive agent for augmentative communication for 2 consecutive days Document each communication's details, ICU LOS, and analgesic-sedative dosages; assess communication difficulty severity, delirium, anxiety, family satisfaction and nurses' communication burden with validated scales.
- Conditions
- Eye Tracking, ICU, Communication Barriers, Non-Verbal Communication
- Being tested
- eye-tracking interactive agent, conventional techniques
- Medical subject headings
- Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye-tracking interactive agentDevice
The eye-tracking interactive agent consists of an eye-tracker, an iPad, and a floor-standing stand. Positioned at the patient's bedside, the system is activated upon the patient's eye opening, allowing the patient to vocalize via this eye-tracking interactive system.
conventional techniquesOther
Nurses communicate with patients through verbal inquiry, hand gestures, head nods or shakes, and simple paper-and-pencil tools; patients unable to write communicate solely via body language. Needs are guessed only when patients exhibit obvious discomfort.
| Study group | Role | What they receive |
|---|---|---|
| eye-tracking group | Experimental | Not described Receives: Device: eye-tracking interactive agent |
| conventional techniques group | Placebo comparator | Not described Receives: Other: conventional techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication difficulty
The degree of communication difficulty in non-verbal ICU patients will be assessed using the Ease of Communication Scale. This tool was revised by Menzel et al. in 1998 and has previously been used to assess communication difficulties among non-verbal patients in the ICU. The scale comprises 6 items, with response options ranging from 0 (no difficulty at all) to 4 (extreme difficulty). The total score ranges from 0 to 24, with higher scores indicating greater communication difficulties.
Measured: up to 2days after enrollment
Secondary outcomes (9)
Communication efficiency
the number of successful communications within 24 hours
Measured: up to 2 days after enrollment
Anxiety
Anxiety level will be measured using the Faces Anxiety Scale. This is a single-item scale with five response options, ranging from neutral expression (1 point) to extreme anxiety (5 points).
Measured: at 4:00 PM daily
Delirium-free days
Delirium-free days refer to the total number of complete calendar days without delirium during the ICU stay.
Measured: through discharge from the ICU，an average of 1 week
Physiological outcomes (heart rate)
The patient's heart rate will be recorded at the start of each communication, and the variability of heart rate during communication will be calculated.
Measured: up to 2 days after enrollment
Physiological outcomes (blood pressure)
The patient's blood pressure will be recorded at the start of each communication, and the variability of blood pressure during communication will be calculated.
Measured: up to 2 days after enrollment
Length of ICU stay
The total length of the patient's ICU stay will be recorded.
Measured: through discharge from the ICU，an average of 1 week
Dosage of analgesic and sedative medications
The daily dosage of analgesic and sedative medications administered to the patient will be recorded.
Measured: up to 2 days after enrollment
Satisfaction of primary caregivers
Family satisfaction will be assessed using the Family Satisfaction in the ICU-24 (FS-ICU-24) scale. This scale consists of 24 items and has been well validated for measuring satisfaction among family members of patients admitted to the ICU. The scale comprises two domains: satisfaction with care and satisfaction with decision-making. Each item is scored on a continuous scale ranging from 0 to 100. The domain score is calculated as the sum of all valid item scores within that domain divided by the number of valid items in the respective domain. The total FS-ICU-24 score is computed as the sum of the two domain mean scores divided by 2, with higher scores representing a higher level of satisfaction.
Measured: through discharge from the ICU，an average of 1 week
Communication burden of medical staffs
The communication burden of ICU nurses was assessed using the NASA Task Load Index (NASA-TLX). This scale has been widely used to evaluate the subjective workload of healthcare providers and covers six domains: mental demand, physical demand, temporal demand, performance level, effort, and frustration. Each of the six domains is scored on a continuous scale ranging from 0 to 100, where a score of 0 indicates the lowest level of the domain and a score of 100 indicates the highest level.
Measured: through study completion，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye TrackingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shining Cai, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429695
- Sponsor's protocol ID
- B2026-073
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-Tracking Interactive Agent in Non-verbal ICU Patients: A Study Protocol of a Randomized Controlled Trial With an Embedded Qualitative Study
- ClinicalTrials.gov ID
- NCT07429695
- Acronym / sponsor ID
- B2026-073
- Conditions
- Eye Tracking, ICU, Communication Barriers, Non-Verbal Communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether an eye-tracking interactive agent can ameliorate communication impairments and reduce the incidence of complications among non-verbal patients in the intensive care unit (ICU). The main questions it aims to answer are:
Does the eye tracking interactive agent alleviate communication impairments among non-verbal patients in the ICU? Does the eye tracking interactive agent improve communication efficiency among non-verbal patients in the ICU? Does the eye tracking interactive agent m reduce the incidence of negative emotions among non-verbal patients in the ICU? Does the eye tracking interactive agent shorten the ICU length of stay for non-verbal patients in the ICU? Does the eye tracking interactive agent reduce the dosage of analgesic and sedative medications for non-verbal patients in the ICU? Does the eye tracking interactive agent improve family satisfaction for non-verbal patients in the ICU? Does the eye tracking interactive agent alleviate nurses' communication burden among non-verbal patients in the ICU? Researchers will compare eye tracking interactive agent to conventional techniques to see if e eye tracking interactive agent works to alleviate communication impairments.
Participants will:
Use an eye tracking interactive agent for augmentative communication for 2 consecutive days Document each communication's details, ICU LOS, and analgesic-sedative dosages; assess communication difficulty severity, delirium, anxiety, family satisfaction and nurses' communication burden with validated scales.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eye-tracking group | Experimental | Device: eye-tracking interactive agent |
| conventional techniques group | Placebo comparator | Other: conventional techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years
- Patients in the ICU who are 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 of -1 to 1
- Primary caregivers are adults
- Able to read Chinese characters and follow simple commands
Key exclusion criteria (3 listed)
- Diseases associated with cognitive impairment, such as pulmonary encephalopathy, hepatic encephalopathy, diabetic hyperosmolar coma, and coma of unknown cause
- A history of mental disorders, dementia or pre-dementia, or intellectual disability
- Conditions precluding cooperation with eye-tracking interaction, such as blindness or inability to elevate the eyelids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye-tracking interactive agentThe eye-tracking interactive agent consists of an eye-tracker, an iPad, and a floor-standing stand. Positioned at the patient's bedside, the system is activated upon the patient's eye opening, allowing the patient to vocalize via this eye-tracking interactive system. | Device | eye-tracking group |
| conventional techniquesNurses communicate with patients through verbal inquiry, hand gestures, head nods or shakes, and simple paper-and-pencil tools; patients unable to write communicate solely via body language. Needs are guessed only when patients exhibit obvious discomfort. | Other | conventional techniques group |
Primary outcome
Communication difficulty
Time frame: up to 2days after enrollment
The degree of communication difficulty in non-verbal ICU patients will be assessed using the Ease of Communication Scale. This tool was revised by Menzel et al. in 1998 and has previously been used to assess communication difficulties among non-verbal patients in the ICU. The scale comprises 6 items, with response options ranging from 0 (no difficulty at all) to 4 (extreme difficulty). The total score ranges from 0 to 24, with higher scores indicating greater communication difficulties.
9 secondary outcomes
Communication efficiency
Time frame: up to 2 days after enrollment
Anxiety
Time frame: at 4:00 PM daily
Delirium-free days
Time frame: through discharge from the ICU，an average of 1 week
Physiological outcomes (heart rate)
Time frame: up to 2 days after enrollment
Physiological outcomes (blood pressure)
Time frame: up to 2 days after enrollment
Length of ICU stay
Time frame: through discharge from the ICU，an average of 1 week
Dosage of analgesic and sedative medications
Time frame: up to 2 days after enrollment
Satisfaction of primary caregivers
Time frame: through discharge from the ICU，an average of 1 week
Communication burden of medical staffs
Time frame: through study completion，an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
Related trials for Eye Tracking
Not yet recruitingObservational study
Expression Intensity Modulates Social Intention Understanding in ASD Children
Autism Spectrum Disorder (ASD)
Recruiting
Sociocultural & Biobehavioral Influences on Pain Expression and Assessment
Normal Physiology, Healthy Volunteers
Not yet recruitingObservational study
Remote Digital Assessments for Cognitive Disorders
Mild Cognitive Impairment (MCI), Alzheimer Disease (AD)
Not yet recruiting
Eye-Tracking Alcohol Warning
Alcohol
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing eye-tracking interactive agent and conventional techniques in people with Eye Tracking and ICU, run by Shanghai Zhongshan Hospital.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Communication difficulty (time frame: up to 2days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2026.