Communication BarriersNCT07205419
Eye-Tracking Communication Tool for Non-verbal ICU Patients
A study testing Eye-Tracking communication tool and Conventional Techniques in people with Communication Barriers and Eye-tracking Technology, run by Shanghai Zhongshan Hospital.
Trial summary
The objectives of this clinical trial are to explore the feasibility of the eye-tracking communication tool in alleviating communication barriers among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this tool in facilitating communication for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication Barriers, Eye-tracking Technology, ICU Patients
- What is being tested?
- Eye-Tracking communication tool and Conventional Techniques
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 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
- 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 ranging from -1 to 1
- able to comply with simple instructions for study participation
- aged ≥ 18 years
- had visitation experiences during the patient's ICU admission
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- aged ≥ 18 years
- registered nurses/physicians employed in the study hospital
- regularly involved in direct ICU care
- at least one year of ICU work experience
Who cannot join
- blindness or inability to elevate the eyelids that preclude successful participation in eye-tracking interaction tasks
- cognitive impairment limiting meaningful participation
- severe psychological distress
- Family members
- cognitive impairment
- severe psychological distress
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- ICU nurses/physicians
- primarily involved in administrative work
- internship or trainee role without regular independent patient care
About this study
Official title: Co-design of an Eye-tracking Communication Tool and a Feasibility Randomized Controlled Trial in Conscious Non-verbal ICU Patients in Shanghai, China: Protocol for a Two-phase Mixed-methods Study
The objectives of this clinical trial are to explore the feasibility of the eye-tracking communication tool in alleviating communication barriers among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this tool in facilitating communication for these patients.
Researchers will compare the eye-tracking communication tool with conventional techniques (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking communication tool in alleviating communication barriers.
Participants will use an eye-tracking communication tool for augmentative communication for 2 consecutive days.
- Being tested
- Eye-Tracking communication tool, Conventional Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-Tracking communication toolDevice
An eye-tracking communication tool developed using a human-centered co-design approach.The eye-tracking communication tool consists of an eye-tracker, a tablet, and a floor-standing stand. The tool will be placed at the patient's bedside 24 hours a day to facilitate real-time communication.
Conventional TechniquesOther
body language (e.g., pointing, nodding, shaking the head) and writing boards
| Study group | Role | What they receive |
|---|---|---|
| Control Group:conventional techniques group | Active comparator | Patients may initiate communication by predefined signals, and primary nurses will assist them in expressing their needs using conventional methods, including body language (e.g., pointing, nodding, shaking the head) and writing boards. Patients unable to write will be supported to express themselves using body language alone. Receives: Other: Conventional Techniques |
| Intervention Group | Experimental | The tool will remain at the bedside. Patients may initiate communication by predefined signals, and primary nurses will assist them in expressing their needs using the eye-tracking communication tool, including support with device positioning, calibration, and interaction. Upon initial use, primary nurses will provide patients with a brief introduction on the tool. Receives: Device: Eye-Tracking communication tool |
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 (7)
Well-being and safety
The degree of well-being and safety in non-verbal ICU patients will be assessed using the practical co-constructed intensive care patients' well-being and safety scale (TOURS Scale). This scale consists of 4 items, with response options ranging from 0 (not at all) to 3 (very). The total score ranges from 0 to 12, with higher scores indicating better well-being and safety.
Measured: at 4:00 PM daily
Satisfaction of family members
Family satisfaction will be assessed using the 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: up to 2 days after enrollment
Communication burden of ICU healthcare professionals
The communication burden of ICU healthcare professionals will be assessed using the 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: up to 2 days after enrollment
Nurses' compliance
Nurses' intervention behaviors will be documented during unscheduled supervision.The compliance of nurses will be defined as the number of communication sessions conducted by nurses with intervention group patients via the communication tool divided by the total number of communication sessions.
Measured: through study completion，an average of 2 year
Time to functional communication
Time to functional communication will be defined as the time (minutes) from initial eye-tracker calibration to the first successfully confirmed communication need. Success requires patient selection via the eye-tracking interface and confirmation of the primary nurse's interpretation by nodding or head shaking. Times will be recorded in a standardized log, unsuccessful communication during the observation period will be recorded as not achieved.
Measured: Day 1
Patient enrollment rate
The patient enrollment rate is calculated as the number of patients who successfully meet the eligibility criteria and are enrolled in the study divided by the total number of patients screened for eligibility during the study period.
Measured: through study completion, an average of 2 year
Patient withdrawal rate
The patient withdrawal rate is defined as the number of enrolled patients who discontinue study participation (for any reason) prior to the completion of the predefined study protocol (e.g., intervention course) divided by the total number of enrolled patients.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication BarriersStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205419
- Sponsor's protocol ID
- ZS202500100
- Status last verified
- May 2026
- First submitted
- 2 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published quantitative results will be available upon reasonable request to the corresponding author after publication of the primary trial results. Requests will be reviewed by the research team, and access will be granted in accordance with applicable ethical, data-protection and institutional requirements. A data-sharing agreement may be required before data are released. Full qualitative interview transcripts will not be shared because of the risk of participant identification.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-design of an Eye-tracking Communication Tool and a Feasibility Randomized Controlled Trial in Conscious Non-verbal ICU Patients in Shanghai, China: Protocol for a Two-phase Mixed-methods Study
- ClinicalTrials.gov ID
- NCT07205419
- Acronym / sponsor ID
- ZS202500100
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Oct 2025 (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 objectives of this clinical trial are to explore the feasibility of the eye-tracking communication tool in alleviating communication barriers among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this tool in facilitating communication for these patients.
Researchers will compare the eye-tracking communication tool with conventional techniques (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking communication tool in alleviating communication barriers.
Participants will use an eye-tracking communication tool for augmentative communication for 2 consecutive days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group:conventional techniques group | Active comparator | Other: Conventional TechniquesPatients may initiate communication by predefined signals, and primary nurses will assist them in expressing their needs using conventional methods, including body language (e.g., pointing, nodding, shaking the head) and writing boards. Patients unable to write will be supported to express themselves using body language alone. |
| Intervention Group | Experimental | Device: Eye-Tracking communication toolThe tool will remain at the bedside. Patients may initiate communication by predefined signals, and primary nurses will assist them in expressing their needs using the eye-tracking communication tool, including support with device positioning, calibration, and interaction. Upon initial use, primary nurses will provide patients with a brief introduction on the tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- aged ≥ 18 years
- 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 ranging from -1 to 1
- able to comply with simple instructions for study participation
- aged ≥ 18 years
Key exclusion criteria (9 listed)
- blindness or inability to elevate the eyelids that preclude successful participation in eye-tracking interaction tasks
- cognitive impairment limiting meaningful participation
- severe psychological distress
- Family members
- cognitive impairment
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 communication toolAn eye-tracking communication tool developed using a human-centered co-design approach.The eye-tracking communication tool consists of an eye-tracker, a tablet, and a floor-standing stand. The tool will be placed at the patient's bedside 24 hours a day to facilitate real-time communication. | Device | Intervention Group |
| Conventional Techniquesbody language (e.g., pointing, nodding, shaking the head) and writing boards | Other | Control Group: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.
7 secondary outcomes
Well-being and safety
Time frame: at 4:00 PM daily
Satisfaction of family members
Time frame: up to 2 days after enrollment
Communication burden of ICU healthcare professionals
Time frame: up to 2 days after enrollment
Nurses' compliance
Time frame: through study completion，an average of 2 year
Time to functional communication
Time frame: Day 1
Patient enrollment rate
Time frame: through study completion, an average of 2 year
Patient withdrawal rate
Time frame: through study completion, an average of 2 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 7 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published quantitative results will be available upon reasonable request to the corresponding author after publication of the primary trial results. Requests will be reviewed by the research team, and access will be granted in accordance with applicable ethical, data-protection and institutional requirements. A data-sharing agreement may be required before data are released. Full qualitative interview transcripts will not be shared because of the risk of participant identification.
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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 communication tool and Conventional Techniques in people with Communication Barriers and Eye-tracking Technology, 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 10 inclusion and 9 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 7 Oct 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. 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 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.