Vision, LowNCT06539728
Validation of Texture Changing Coatings for Use in At-Home Rapid Tests
A study testing Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces, Biomechanical Measurements and Psychophysical Tasks in people with Vision, Low and Blindness, run by University of Delaware at 1 site in United States.
Trial summary
At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision, Low, Blindness
- What is being tested?
- Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces, Biomechanical Measurements and Psychophysical Tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Visual Impairment: Participants should be blind or visually impaired for greater than 10 years, either congenitally or acquired.
- Tactile Aid Usage: Participants must use tactile aids regularly.
- Mathematical Knowledge: Participants should have a basic understanding of mathematical plots, equivalent to at least high school geometry.
Who cannot join
- Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Delaware
Newark, Delaware, 19711
Charles Dhong, PhD
About this study
Official title: Validation of Texture-Changing Tactile Coatings for Potential Use in Accessible At-Home Care
At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change, which people can feel by touch. This platform could be used not only for COVID, but also for other diagnostics, and will promote the independence and privacy for people with low vision or blindness by removing the need for human assistance or an internet connection.
Read the detailed description
Current at-home COVID tests are not accessible to people with low vision or blindness. To interpret results, people with low vision or blindness may need a sighted assistant, an internet-based image recognition tool, or some other sort of powered implement. Instead of adapting to technologies developed for sighted people, investigators propose a new platform which provides a no-power tactile readout, i.e., a texture change, to interpret test results. Although COVID antigens are at relatively low concentrations in human saliva, by relying on surface chemistry effects, a relatively small amount of sample can be designed to cause a significant texture change. This project will develop a new class of antibody-conjugated polymers which, in a saliva sample, bind to COVID antigen. In conjunction, investigators will also develop a test surface designed to maximize tactile feedback upon antigen binding. Upon binding to the test surface, a COVID positive surface will feel distinctive from the negative control, like distinguishing between plastic and glass. To optimize polymer design and test surface design, investigators use a combination of materials characterization, mechanical testing, human testing, and computational techniques. The project culminates by having low vision or blind users test the device with synthetic saliva solutions containing COVID antigen, present as innocuous protein isolates. Subjects will receive synthetic saliva with and without COVID antigen, and using our platform, will be asked to determine if the synthetic saliva did contain the COVID antigen. As a platform, the technology is not limited to COVID, but could be adapted to either new variants or other use cases, such as pregnancy tests. Investigators expertise combines accessibility experts, synthetic chemists, human psychophysics, computational simulations, surface science, and mechanics. To maximize project success, the project includes people with visual impairments at all stages to ensure practicality.
- Conditions
- Vision, Low, Blindness
- Being tested
- Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces, Biomechanical Measurements, Psychophysical Tasks
- Keywords
- Tactile Aid
- Medical subject headings
- Vision, Low, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction with Mock COVID-19 Rapid Antigen Test and Reference SurfacesDiagnostic test
Participants will drop a saline solution with proteins onto the testing device. They will wait for it to dry and then report on the tactile sensation and overall feel of the surface. Feedback will include comparisons with the two reference surfaces. The primary goal is to determine the presence of mock COVID antigen in synthetic saliva using the device, which aligns with the goals of diagnostic testing.
Biomechanical MeasurementsDiagnostic test
Participants may have biomechanical measurements recorded, such as placing samples on a scale to measure downward force or using medical tape with a flexible wire to track finger motion. These measurements are likely aimed at objectively assessing how participants interact with the surfaces and their physical responses to tactile stimuli.
Psychophysical TasksBehavioural
Participants may alternatively be asked to perform standardized psychophysical tasks, such as Two Alternative Forced Choice tests, Odd-Man Out tests, or Magnitude Estimation tests. These tasks will provide structured comparisons and quantitative data on participants' perception and preferences regarding tactile qualities. The tasks are designed to evaluate participants' perception and preferences regarding tactile qualities, which involves behavioral responses to sensory stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Interaction with Coated Surfaces | Experimental | Participants in this arm will interact with the device and surface coated with the polymer-antibody coating. Subjects will be trained with a "positive" test and "negative" test prior to device testing. Subjects will then administer the synthetic saliva themselves and asked to determine if there was COVID antigen in the saliva by touching the device to compare the test patch to the positive and negative control patches. Subjects will also rate device usability. Receives: Diagnostic Test: Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces; Diagnostic Test: Biomechanical Measurements; Behavioral: Psychophysical Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of identifying whether the model test is positive or negative
After familiarization, test trials will involve participants dropping a test solution onto the device with a test slab as well as positive and negative control slabs. They will be asked to identify whether the test is positive or negative, based on how the test slab feels to the touch compared to the controls. Participants will be evaluated on whether or not their response is correct. This will be repeated 10 times per participant to record a percentage of success.
Measured: Through study completion, an average of 1 year
Response time of each trial of a participant identifying whether the model test is positive or negative
A Qualtrics form will be used to record participant responses. Each trial will have its own page on the form during data collection. A trial will begin when the test administrator opens its page, and participants will be prompted to decide whether the device is displaying a positive or negative result. Once participants choose, the administrator will select their answers on the form, and the time to the last click will be recorded as their response time. This will be repeated 10 times.
Measured: Through study completion, an average of 1 year
Usability feedback
Subjects participating in the clinical trial will be invited to provide feedback on the usability and their preferences regarding the tactile aid introduced in the study. The assessment will be conducted using a modified Likert scale. This outcome aims to gather subjective experiences related to the use of new tactile aids throughout the trials. Throughout the study, participants will be consistently asked to comment on the usability and their preferences based on the tactile aid. This ongoing feedback will enable a comprehensive understanding of their experiences over time.
Modified Likert Scale:
Strongly Disagree Disagree Somewhat Disagree Neutral Somewhat Agree Agree Strongly Agree Extremely Agree Exceptionally Agree
Title: Usability of Tactile Aid Min: 1 Max: 9 Higher the score, the better the outcome/ usability of the tactile aid.
Measured: Through study completion, an average of 1 year
General feedback
Subjects participating in the clinical trial will be invited to provide feedback on the usability and their preferences regarding the tactile aid introduced in the study. The assessment will be conducted by asking participants for general feedback on the device they used. Throughout the study, participants will be consistently asked to comment on the usability and their preferences based on the tactile aid. This ongoing feedback will enable a comprehensive understanding of their experiences over time.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study startJun 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision, LowStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539728
- Sponsor's protocol ID
- 2181777
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Texture-Changing Tactile Coatings for Potential Use in Accessible At-Home Care
- ClinicalTrials.gov ID
- NCT06539728
- Acronym / sponsor ID
- 2181777
- Conditions
- Vision, Low, Blindness
- Keywords
- Tactile Aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change, which people can feel by touch. This platform could be used not only for COVID, but also for other diagnostics, and will promote the independence and privacy for people with low vision or blindness by removing the need for human assistance or an internet connection.
Detailed description
Current at-home COVID tests are not accessible to people with low vision or blindness. To interpret results, people with low vision or blindness may need a sighted assistant, an internet-based image recognition tool, or some other sort of powered implement. Instead of adapting to technologies developed for sighted people, investigators propose a new platform which provides a no-power tactile readout, i.e., a texture change, to interpret test results. Although COVID antigens are at relatively low concentrations in human saliva, by relying on surface chemistry effects, a relatively small amount of sample can be designed to cause a significant texture change. This project will develop a new class of antibody-conjugated polymers which, in a saliva sample, bind to COVID antigen. In conjunction, investigators will also develop a test surface designed to maximize tactile feedback upon antigen binding. Upon binding to the test surface, a COVID positive surface will feel distinctive from the negative control, like distinguishing between plastic and glass. To optimize polymer design and test surface design, investigators use a combination of materials characterization, mechanical testing, human testing, and computational techniques. The project culminates by having low vision or blind users test the device with synthetic saliva solutions containing COVID antigen, present as innocuous protein isolates. Subjects will receive synthetic saliva with and without COVID antigen, and using our platform, will be asked to determine if the synthetic saliva did contain the COVID antigen. As a platform, the technology is not limited to COVID, but could be adapted to either new variants or other use cases, such as pregnancy tests. Investigators expertise combines accessibility experts, synthetic chemists, human psychophysics, computational simulations, surface science, and mechanics. To maximize project success, the project includes people with visual impairments at all stages to ensure practicality.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interaction with Coated Surfaces | Experimental | Diagnostic Test: Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces, Diagnostic Test: Biomechanical Measurements, Behavioral: Psychophysical TasksParticipants in this arm will interact with the device and surface coated with the polymer-antibody coating. Subjects will be trained with a "positive" test and "negative" test prior to device testing. Subjects will then administer the synthetic saliva themselves and asked to determine if there was COVID antigen in the saliva by touching the device to compare the test patch to the positive and negative control patches. Subjects will also rate device usability. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Visual Impairment: Participants should be blind or visually impaired for greater than 10 years, either congenitally or acquired.
- Tactile Aid Usage: Participants must use tactile aids regularly.
- Mathematical Knowledge: Participants should have a basic understanding of mathematical plots, equivalent to at least high school geometry.
Key exclusion criteria (1 listed)
- Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.
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 |
|---|---|---|
| Interaction with Mock COVID-19 Rapid Antigen Test and Reference SurfacesParticipants will drop a saline solution with proteins onto the testing device. They will wait for it to dry and then report on the tactile sensation and overall feel of the surface. Feedback will include comparisons with the two reference surfaces. The primary goal is to determine the presence of mock COVID antigen in synthetic saliva using the device, which aligns with the goals of diagnostic testing. | Diagnostic test | Interaction with Coated Surfaces |
| Biomechanical MeasurementsParticipants may have biomechanical measurements recorded, such as placing samples on a scale to measure downward force or using medical tape with a flexible wire to track finger motion. These measurements are likely aimed at objectively assessing how participants interact with the surfaces and their physical responses to tactile stimuli. | Diagnostic test | Interaction with Coated Surfaces |
| Psychophysical TasksParticipants may alternatively be asked to perform standardized psychophysical tasks, such as Two Alternative Forced Choice tests, Odd-Man Out tests, or Magnitude Estimation tests. These tasks will provide structured comparisons and quantitative data on participants' perception and preferences regarding tactile qualities. The tasks are designed to evaluate participants' perception and preferences regarding tactile qualities, which involves behavioral responses to sensory stimuli. | Behavioural | Interaction with Coated Surfaces |
Primary outcome
Success rate of identifying whether the model test is positive or negative
Time frame: Through study completion, an average of 1 year
After familiarization, test trials will involve participants dropping a test solution onto the device with a test slab as well as positive and negative control slabs. They will be asked to identify whether the test is positive or negative, based on how the test slab feels to the touch compared to the controls. Participants will be evaluated on whether or not their response is correct. This will be repeated 10 times per participant to record a percentage of success.
Response time of each trial of a participant identifying whether the model test is positive or negative
Time frame: Through study completion, an average of 1 year
A Qualtrics form will be used to record participant responses. Each trial will have its own page on the form during data collection. A trial will begin when the test administrator opens its page, and participants will be prompted to decide whether the device is displaying a positive or negative result. Once participants choose, the administrator will select their answers on the form, and the time to the last click will be recorded as their response time. This will be repeated 10 times.
Usability feedback
Time frame: Through study completion, an average of 1 year
Subjects participating in the clinical trial will be invited to provide feedback on the usability and their preferences regarding the tactile aid introduced in the study. The assessment will be conducted using a modified Likert scale. This outcome aims to gather subjective experiences related to the use of new tactile aids throughout the trials. Throughout the study, participants will be consistently asked to comment on the usability and their preferences based on the tactile aid. This ongoing feedback will enable a comprehensive understanding of their experiences over time. Modified Likert Scale: Strongly Disagree Disagree Somewhat Disagree Neutral Somewhat Agree Agree Strongly Agree Extremely Agree Exceptionally Agree Title: Usability of Tactile Aid Min: 1 Max: 9 Higher the score, the better the outcome/ usability of the tactile aid.
General feedback
Time frame: Through study completion, an average of 1 year
Subjects participating in the clinical trial will be invited to provide feedback on the usability and their preferences regarding the tactile aid introduced in the study. The assessment will be conducted by asking participants for general feedback on the device they used. Throughout the study, participants will be consistently asked to comment on the usability and their preferences based on the tactile aid. This ongoing feedback will enable a comprehensive understanding of their experiences over time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Vision, Low
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
Diabetic Macular Edema (DME)
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces, Biomechanical Measurements and Psychophysical Tasks in people with Vision, Low and Blindness, run by University of Delaware at 1 site in United States.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Dhong, PhD (302-831-2828, cdhong@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of identifying whether the model test is positive or negative (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 6 Apr 2025.