Wearable Echolocation Aids Using Parametric Sound

The University of Texas System (UT)

Status: Enrolling

Conditions: Low Vision

Treatments: Device: Wearable Echolocation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07218991

24-0032

Details and patient eligibility

About

The objective of this study is to study a novel device designed to aid patients with impaired vision to safely navigate their environment. Subjects for this study will be individuals with normal vision, either with or without correction. The subjects will wear a device to simulate impaired vision and will be asked to walk a path with randomly placed obstacles during two trials. One of the trials will consist of the subject wearing the simulator alone. The other trial will consist of the subject wearing the simulator and the study device. The study device is designed to be worn by the study subject and will emit tones to indicate obstacles in the environment as the subject walks on the path with random obstacles. The tones will indicate that there is an obstacle in the individual's path and will increase in intensity as the subject moves closer to the object.Invest

Full description

The objective of this project is to study visually impaired individuals' ability to develop echolocation skills using simple, wearable, echolocation devices that will not be cost prohibitive to most Americans and that would allow for greater availability to the visually impaired community. These echolocation devices emit parametric sound, a directional beam of ultrasound waves that interact with sound waves and surrounding objects, through goggles, watches, lanyards or even walking canes. This allows the visually impaired individual to detect sound waves as they reflect off their surroundings and return to the patient's ears in unique patterns resembling their external environment. This device would enable individuals to create a raw mental image of their surroundings and any obstacles along their path.

The primary endpoint for this pilot study is to assess the feasibility of such echolocation devices as an adaptive low vision navigation aid on healthy subjects using low vision simulation goggles. Several metrics will be observed and recorded to measure how well echolocation technology addresses challenges associated with visual impairment and downstream factors. These metrics will include gait initiation, termination analysis via the Zeno-Walkway system, electromyography (EMG) of key muscles involved in gait termination, participant preference of echolocation wearable device modularity, and general survey questions.

The secondary study endpoint is to implement the use of echolocation technology among members of the blind or visually impaired population as a clinical aid and study the impact that this technology has on their quality of life and added downstream health implications longitudinally.

A final objective of this study is to seek feedback, not only on the use of any echolocation device to navigate but, to obtain feedback on subjects' experience with the specific study device, the Wearable Echolocation Device.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject has provided informed consent in a manner approved by the Institutional Review Board (IRB) and is willing and able to comply with the trial procedures.
• Adults at least 18 years of age and no older than 100 years of age at the time of consent.
• Individuals in good health who can perform daily activities without assistance and can walk independently.
• Normal vision (with or without corrective lenses) if there is no uncorrectable visual impairment.

Exclusion criteria

• History of gait problems.
• Foot or leg impairments.
• Hearing impairment.
• Vertigo or other balance problems.
• Pregnant individuals.
• Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
• Medications that may cause dizziness or weakness.
• Concurrent participation on another research study.
• Use of an investigational agent in the 30 days prior to signing informed consent.
• History of prior non-compliance.
• Presence or history of psychiatric condition (including anxiety, psychosis, drug, or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
• Non-English-speaking individuals.
• Individuals from special or vulnerable populations (i.e., adults unable to consent, minors, incarcerated individuals).
• Body weight greater than 700 pounds.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group 1 - Wearing a Low-Vision Simulator without the Wearable Echolocation Device

No Intervention group

Description:

The participant will be wearing a low-vision simulator and navigating a pathway randomly populated with obstacles. They will then perform the same trial, wearing the low vision simulator, navigating the same pathway with obstacles randomly rearranged; however, the participants will use the Wearable Echolocation Device to assist with navigation.

Group 2- Wearing a Low-Vision Simulator with the Wearable Echolocation Device

Active Comparator group

Description:

The participants will be wearing the low-vision simulator and the wearable echolocation Device for the first test to assist with navigating the pathway randomly populated with obstacles. The participant will then perform the same test, wearing the low-vision simulator without the Wearable Echolocation Device, navigating the same pathway with randomly rearranged obstacles.

Treatment:

Device: Wearable Echolocation Device