Wearable Echolocation Aids Using Parametric Sound

October 24, 2025 updated by: The University of Texas Medical Branch, Galveston
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Praveena Gupta, PhD OD FAAO
  • Phone Number: (409) 747-5823
  • Email: prgupta@utmb.edu

Study Contact Backup

  • Name: Stacy M Schreiber Lopez, AA BS MA
  • Phone Number: 2814602704
  • Email: smschrei@UTMB.EDU

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
          • Stacy M Schreiber Lopez, AA BS MA
          • Phone Number: 2814602704
          • Email: smschrei@UTMB.EDU
        • Contact:
          • Praveena Gupta, PhD OD FAAO
          • Phone Number: 409-747-5823
          • Email: prgupta@utmb.edu
        • Sub-Investigator:
          • Aisen Chacin, PhD
        • Sub-Investigator:
          • Mansoo Ko, PT PhD
        • Sub-Investigator:
          • Pranati Ahuja, BS MS MD
        • Sub-Investigator:
          • James Chen, BA
        • Sub-Investigator:
          • Sophia Choi, BS
        • Sub-Investigator:
          • Thomas Radle, BA, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Group 1 - Wearing a Low-Vision Simulator without the Wearable Echolocation Device
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.
Active Comparator: Group 2- Wearing a Low-Vision Simulator with the Wearable Echolocation Device
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.
Device: Wearable Echolocation Device
The device features many parametric speakers housed in a plastic case. The parametric speakers emit directional sound waves that return to the source with varying wavelengths depending on the distance of the surrounding objects. The device is designed to be worn by the subject either using a lanyard on the subject's neck, or on the subject's wrist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Stride Length for Visually Impaired Individuals with Implementation of Echolocation Technology
Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session)
Stride length will be measured using the Zeno Walkway system, an electronic, pressure-sensitive mat connected to a PC that automates the measurement of spatial and temporal aspects of gait. The walkway's high-resolution sensors capture real-time data as participants walk across it. Each participant will walk on the instrumented mat for approximately 30 minutes, allowing for detailed analysis of stride length. Mean stride length (in meters) will be calculated from multiple trials to assess changes following implementation of echolocation technology.
Baseline (pre-training) and immediately post-training (same 30 minute session)
Change in Cadence for Visually Impaired Individuals with Implementation of Echolocation Technology
Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session)
Cadence (steps per minute) will be assessed using the Zeno Walkway system, an electronic, pressure-sensitive mat that captures real-time gait data. Participants will walk across the instrumented walkway for approximately 30 minutes. The system will automatically record and calculate the average number of steps per minute to evaluate changes in cadence following implementation of echolocation technology.
Baseline (pre-training) and immediately post-training (same 30 minute session)
Change in Walking Velocity for Visually Impaired Individuals with Implementation of Echolocation Technology
Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session)
Walking velocity will be measured using the Zeno Walkway system, an electronic, pressure-sensitive mat that captures spatial and temporal aspects of gait. Participants will walk across the walkway for approximately 30 minutes. The system will automatically calculate average walking velocity (in meters per second) based on distance and time. This outcome will be used to evaluate improvements in gait speed following implementation of echolocation technology.
Baseline (pre-training) and immediately post-training (same 30 minute session)
Change in Body Mass Index (BMI) for Visually Impaired Individuals with Implementation of Echolocation Technology
Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session)
Body Mass Index (BMI) will be calculated using standard anthropometric measures of height and weight (weight in kilograms divided by height in meters squared). Measurements will be taken at each study visit to assess any change in BMI that may occur following implementation of echolocation technology.
Baseline (pre-training) and immediately post-training (same 30 minute session)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant-Reported Experience with Echolocation Device
Time Frame: Day 1
Participants will complete the "Wearable Echolocation Aids Using Parametric Sound: Post-Trials Survey" to evaluate their experience using the echolocation device during the study.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Praveena M Gupta, PhD OD FAAO, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-0032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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