Eye-Tracking Interaction System for Non-verbal ICU Patients

NCT ID: NCT07205419

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2027-03-31

Brief Summary

The objectives of this clinical trial are to explore the feasibility of the eye-tracking interactive system in improving communication disorders among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this system in facilitating communication for these patients.

Researchers will compare the eye-tracking interactive system with traditional augmentative and alternative communication (AAC) technologies (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking interactive system in improving communication disorders.

Participants will:

• Use augmentative and alternative communication technologies daily
• Have detailed records of every communication interaction

Conditions

Communication Barriers; Eye-tracking Technology; ICU Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Group:

Charge nurses will lead communication through body language (e.g., pointing, nodding, shaking the head) or by providing writing boards for patients to write. Patients unable to write will communicate solely through body language.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Charge nurses will lead communication using the eye-tracking interaction system. An eye-tracking interaction system refers to an eye-tracking interaction interface installed on any electronic device equipped with a camera that meets the configuration requirements.

Group Type: EXPERIMENTAL

Eye-Tracking Interaction System

Intervention Type: DEVICE

The eye-tracking interactive interface designed based on evidence-based and co-design principles is installed on tablets or computers equipped with cameras, forming the eye-tracking interactive system.

Interventions

Eye-Tracking Interaction System

The eye-tracking interactive interface designed based on evidence-based and co-design principles is installed on tablets or computers equipped with cameras, forming the eye-tracking interactive system.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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;④Primary caregivers are adults
• Able to read Chinese characters and follow simple commands
• Willing to participate in this study

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZS202500100

Identifier Type: -

Identifier Source: org_study_id