Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:18 AM
Study NCT ID:
NCT07429695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye-Tracking Interactive Agent in Non-verbal ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009633', 'term': 'Nonverbal Communication'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Communication difficulty', 'timeFrame': 'up to 2days after enrollment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Communication efficiency', 'timeFrame': 'up to 2 days after enrollment', 'description': 'the number of successful communications within 24 hours'}, {'measure': 'Anxiety', 'timeFrame': 'at 4:00 PM daily', 'description': '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).'}, {'measure': 'Delirium-free days', 'timeFrame': 'through discharge from the ICU，an average of 1 week', 'description': 'Delirium-free days refer to the total number of complete calendar days without delirium during the ICU stay.'}, {'measure': 'Physiological outcomes (heart rate)', 'timeFrame': 'up to 2 days after enrollment', 'description': "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."}, {'measure': 'Physiological outcomes (blood pressure)', 'timeFrame': 'up to 2 days after enrollment', 'description': "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."}, {'measure': 'Length of ICU stay', 'timeFrame': 'through discharge from the ICU，an average of 1 week', 'description': "The total length of the patient's ICU stay will be recorded."}, {'measure': 'Dosage of analgesic and sedative medications', 'timeFrame': 'up to 2 days after enrollment', 'description': 'The daily dosage of analgesic and sedative medications administered to the patient will be recorded.'}, {'measure': 'Satisfaction of primary caregivers', 'timeFrame': 'through discharge from the ICU，an average of 1 week', 'description': '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.'}, {'measure': 'Communication burden of medical staffs', 'timeFrame': 'through study completion，an average of 1 year', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye Tracking', 'ICU', 'Communication Barriers', 'Non-Verbal Communication']}, 'descriptionModule': {'briefSummary': "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:\n\nDoes 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.\n\nParticipants will:\n\nUse 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years\n* 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.\n* Richmond Agitation-Sedation Scale (RASS) score of -1 to 1\n* Primary caregivers are adults\n* Able to read Chinese characters and follow simple commands\n* Willing to participate in this study.\n\nExclusion Criteria:\n\n* Diseases associated with cognitive impairment, such as pulmonary encephalopathy, hepatic encephalopathy, diabetic hyperosmolar coma, and coma of unknown cause\n* A history of mental disorders, dementia or pre-dementia, or intellectual disability\n* Conditions precluding cooperation with eye-tracking interaction, such as blindness or inability to elevate the eyelids.'}, 'identificationModule': {'nctId': 'NCT07429695', 'briefTitle': 'Eye-Tracking Interactive Agent in Non-verbal ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Eye-Tracking Interactive Agent in Non-verbal ICU Patients: A Study Protocol of a Randomized Controlled Trial With an Embedded Qualitative Study', 'orgStudyIdInfo': {'id': 'B2026-073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eye-tracking group', 'interventionNames': ['Device: eye-tracking interactive agent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'conventional techniques group', 'interventionNames': ['Other: conventional techniques']}], 'interventions': [{'name': 'eye-tracking interactive agent', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['eye-tracking group']}, {'name': 'conventional techniques', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['conventional techniques group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'charge nurse', 'investigatorFullName': 'Shining Cai', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}