Assistive Communication Devices for Visual Impairment

(VIS4ION Trial)

No longer recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive dysfunction, Neurological illness, Mobility restrictions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device designed to help people with visual impairments navigate their surroundings more easily. Known as Assistive Tactile and Auditory Communicating Devices, it combines sensors and a smartphone to send real-time information about obstacles through vibrations and sound. The goal is to determine if this technology improves navigation and quality of life. People with any level of visual impairment, but no serious cognitive or mobility issues, may be suitable for this trial. Participants will help researchers understand how the device functions in real-world settings and guide future improvements. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly enhance daily living for individuals with visual impairments.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this assistive communication device is safe for visually impaired individuals?

Research shows that assistive devices, like the one tested in this study, are generally easy to use and safe. These devices use technology to help people with vision impairments improve their daily lives. Current studies indicate that these technologies usually do not cause major safety issues.

The devices in this study include a vest with sensors, a belt that vibrates to provide feedback, a smartphone, and a headset. These components work together to help users navigate more easily. Although detailed safety data for this specific system is not yet available, the technologies used are common in many assistive devices and are generally considered safe.

Overall, evidence suggests that these assistive technologies are safe for use, with few reports of problems. Users often find that these devices enhance their interaction with surroundings, making daily activities easier. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these assistive tactile and auditory communication devices because they offer a new way for visually impaired individuals to interact with their surroundings. Unlike traditional options like braille or screen readers, these devices use advanced tactile feedback and auditory cues to enhance communication and spatial awareness. By integrating these unique features, the devices aim to provide a more intuitive and seamless experience, potentially improving the quality of life for those with visual impairments.

What evidence suggests that these assistive communication devices are effective for visual impairment?

Research shows that devices using touch and sound can assist people who are visually impaired. In this trial, participants will test various configurations of assistive tactile and auditory communication devices. Studies have found that vibrations effectively guide users, even in noisy environments, helping them detect obstacles and navigate more easily. Other research supports that these technologies generally enhance life for blind individuals by making movement safer and communication easier. Combining touch feedback and sound in these devices provides helpful real-time information about the surroundings, aiding users in more effective navigation. Overall, these devices hold great potential to improve daily life for those with visual impairments. ^{1 6 7 8 9}

Who Is on the Research Team?

John R Rizzo, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with varying levels of visual impairment. Participants should be able to perform tasks without significant cognitive dysfunction (scoring at least 24 on a mental status exam), have no major neurological illnesses or complicated medical conditions, and not have severe mobility restrictions such as needing walkers or wheelchairs.

Inclusion Criteria

I have a visual impairment.

Exclusion Criteria

Pregnancy

You have significant problems with memory and thinking, as measured by a specific test.

I use a walker or wheelchair due to significant mobility issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Testing

Initial testing of the VIS4ION platform's tactile and auditory communication outputs

1 month

Multiple visits for testing and feedback

Crossover Phase

Prospective, randomized crossover phase to evaluate the effectiveness of the wearable vest

1 month

Daily visits for 30 days

Extended-Use Experiment

Testing of the improved system in an extended-use experiment to detect health-related changes

6 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Assisstive Tactile and Auditory Communicating Devices

Trial Overview The study tests the VIS4ION System, which includes a sensor-embedded vest, a haptic feedback belt, smartphone connectivity, and bone conduction headset. It aims to improve navigation for visually impaired people by providing real-time spatial information through tactile and auditory means.

How Is the Trial Designed?

Group I: Visually impaired Experimental Treatment 1 Intervention

Visually impaired subjects will provide continuity across iterations of the testing, allowing for direct comparisons of responses within an individual for a single behavioral measure across different iterations of the device architecture and output configuration.

Group II: Thailand Site - Group A: Assistive Mode then Passive Mode Experimental Treatment 1 Intervention

During the first 15 days, group A will go through an assistive mode and then a passive mode for the next 15 days

Group III: Healthy controls Active Control 1 Intervention

Healthy (naive) subjects invaluable insights as well as a range of body types, cognitive abilities, and other idiosyncrasies that will keep our design and testing process from tailoring the device to a small set of individuals rather than the broader population.

Group IV: Thailand Site - Group B: Passive Mode then Assistive Mode Active Control 1 Intervention

Group B will go through a passive mode for the first 15 days and then an assistive mode for the second half of the month

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2590137022001583

Towards assisting visually impaired individuals: A review ... This study examines contemporary assistive devices and technologies for the visually handicapped. These techniques are classified according to their functions ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6930908/

Comparing Tactile to Auditory Guidance for Blind Individuals These results suggest that tactile navigation holds promise as an effective method in everyday environments characterized by ambient noise such ...

3. atia.org atia.org/wp-content/uploads/2021/03/V15_WalkerWegner.pdf

Eye-Gaze Access and Cortical Visual Impairment A feasibility case study was conducted to determine if eye-gaze training programs could be used to teach an individual with cortical visual ...

4. nature.com nature.com/articles/s41598-025-14946-5

Leveraging assistive technology for visually impaired ... Therefore, the use of assistive techniques can help alleviate the adverse effects and enhance the quality of life for people who are blind. Most ...

5. pubs.asha.org pubs.asha.org/doi/10.1044/2023_AJSLP-22-00397

An Evidence-Based Approach to Augmentative and ... An AAC system design that is tailored to the unique visual processing characteristics in CVI is likely to promote positive communication outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10281573/

Virtual reality as a means to explore assistive technologies for ... Visual impairment represents a significant health and economic burden affecting 596 million globally. The incidence of visual impairment is ...

7. mdpi.com mdpi.com/1424-8220/24/11/3572

Assistive Systems for Visually Impaired Persons This review paper highlights the state-of-the-art assistive technology, tools, and systems for improving the daily lives of visually impaired people.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11314945/

A Comprehensive Survey on Emerging Assistive ... This article emphasizes the potential of Artificial Intelligence (AI) and Visible Light Communications (VLC) in developing future assistive technologies.

9. europarl.europa.eu europarl.europa.eu/RegData/etudes/IDAN/2018/603218/EPRS_IDA(2018)603218(ANN2)_EN.pdf

Assistive technologies for people with disabilities This study focuses on assistive technologies (AT) for three specific conditions of disability: 1) blindness and visual impairment; 2) deafness and auditory ...