Eye Tracking for Early Identification of Post-ICU Cognitive Impairment

NCT07676864 | Not Yet Recruiting

• 1 other identifier: B2026-360
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Some patients may have problems with memory, attention, thinking speed, or other cognitive functions after leaving the intensive care unit (ICU). This is called post-ICU cognitive impairment. Early recognition of this problem may help clinicians provide follow-up care and support more promptly. This study will explore whether eye-tracking technology can help identify cognitive impairment in patients soon after ICU discharge. Eye tracking is a non-invasive test that records eye movements while a person looks at images or completes simple visual tasks on a screen. The test does not involve any treatment or change in usual medical care. Participants will be adult patients who have been transferred from the ICU to a general ward. Within 7 days after ICU discharge, participants will complete a cognitive assessment and an eye-tracking test. The study team will also collect relevant clinical information from medical records. Patients will be grouped according to whether they have post-ICU cognitive impairment based on cognitive assessment and clinical judgment. The main purpose of this study is to assess whether information obtained from eye-tracking tests can help clinicians identify possible post-ICU cognitive impairment at an early stage, when used together with standard cognitive assessment. The study will also compare eye movement patterns between the two groups and explore whether eye-tracking measures add useful information beyond standard cognitive assessment.

Conditions

Post Intensive Care Syndrome (PICS); Cognitive Impairment

Keywords

Eye Tracking; Cognitive Impairment; Cognitive Assessment; Intensive Care Unit; Post intensive Care Syndrome

Outcome Measures

Primary Outcomes (1)

• Auxiliary Identification Performance of Eye-Tracking-Derived Parameters for Post-ICU Cognitive Impairment

  The area under the receiver operating characteristic curve (AUC) will be used to evaluate how well selected eye-tracking-derived parameters, alone or in combination, support the identification of post-ICU cognitive impairment. Post-ICU cognitive impairment will be determined using DSM-5 neurocognitive disorder criteria together with clinical assessment and education-corrected Montreal Cognitive Assessment (MoCA) score.

  Within 7 days after ICU discharge

Secondary Outcomes (2)

• Occurrence of Post-ICU Cognitive Impairment

  Within 7 days after ICU discharge

• Differences in Eye-Tracking-Derived Parameters Between Cognitive Status Groups

  Within 7 days after ICU discharge

Study Arms (2)

Post-ICU Cognitive Impairment Group

Participants diagnosed with post-ICU cognitive impairment based on DSM-5 criteria, clinical assessment, and corrected MoCA score.

Non-Post-ICU Cognitive Impairment Group

Participants without post-ICU cognitive impairment based on DSM-5 criteria, clinical assessment, and corrected MoCA score.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients who have been successfully transferred from the intensive care unit (ICU) to a general ward after ICU treatment at Zhongshan Hospital, Fudan University. Eligible participants will have stayed in the ICU for at least 24 hours, be conscious, and be able to complete cognitive assessment and eye-tracking tests. Participants will undergo study assessments within 7 days after ICU discharge. No intervention will be assigned by the study.

You may qualify if:

• Successfully transferred from the ICU to a general ward after ICU treatment.
• ICU length of stay of at least 24 hours.
• Conscious and able to cooperate with cognitive assessment and eye-tracking tests.
• Willing to participate in the study and able to provide written informed consent.

You may not qualify if:

• Diagnosed with cognitive impairment before ICU admission, such as Alzheimer's disease, based on medical history or previous medical records.
• Previous diagnosis of mental illness or intellectual developmental disorder.
• Severe visual, hearing, or eye disease that prevents completion of cognitive assessment or eye-tracking tasks.
• Severe neurological disease that may affect cognitive function, such as stroke, traumatic brain injury, or intracranial infection.
• Unable to understand or complete the cognitive assessment or eye-tracking tasks due to severe fatigue, marked inattention, communication disorder, or other reasons as assessed by the research staff.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, China

Location

MeSH Terms

Conditions

postintensive care syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ai rong Zhu, Bachelor's Degree

CONTACT

+86 15160007359; 2471015405@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)