Eye-Tracking Interactive Agent in Non-verbal ICU Patients

NCT07429695 | Not Yet Recruiting

• 1 other identifier: B2026-073
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Eye Tracking; ICU; Communication Barriers; Non-Verbal Communication

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2days after enrollment

Secondary Outcomes (9)

• Communication efficiency

  up to 2 days after enrollment

• Anxiety

  at 4:00 PM daily

• Delirium-free days

  through discharge from the ICU，an average of 1 week

• Physiological outcomes (heart rate)

  up to 2 days after enrollment

• Physiological outcomes (blood pressure)

  up to 2 days after enrollment

Study Arms (2)

eye-tracking group

EXPERIMENTAL

Device: eye-tracking interactive agent

conventional techniques group

PLACEBO COMPARATOR

Other: conventional techniques

Interventions

eye-tracking interactive agent DEVICE

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.

eye-tracking group

conventional techniques OTHER

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.

conventional techniques group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Nonverbal Communication

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: charge nurse

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02