V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool

March 6, 2024 updated by: Vortant Technologies, LLC

V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation

The study will begin with an explanatory/training session where individuals with low vision will learn to use the V-NAV (Vortant NAVigation tool) indoor navigation app, and will have the opportunity to try it for a few representative tasks. The main activity includes a take-home trial, an extended unstructured period to emulate the post-purchase experience of users, during which participants will have the opportunity to use the V-NAV in their everyday lives. Data will be collected from the users to measure the relative advantage of V-NAV compared to the user's current indoor navigation method.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The introductory session, emphasizing real-world experiences, will involve a brief training session followed by simulated navigation experiences in a convenient location to the users. Participants will use V-NAV to record approximately 8 locations, then will be given instructions to find these locations again. The V-NAV prototype's logging software will measure distance walked and task time. Participants will complete a study-specific tool covering the relevant attributes of the V-NAV prototype, as well as a standardized tool, the NASA TLX (Task Load Index).

Subsequently, participants will complete a take-home trial, during which they will be encouraged to use the V-NAV features regularly to support their everyday community navigation activities. Participants will be contacted approximately weekly with a "check-in" to answer questions and resolve any emergent technical problems. At the conclusion of the trial, a product-specific tool and an appropriate standardized tool, the PIADS (Psychosocial Impact of Assistive Devices Scale) will be administered.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • 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

  • Name: Philip R Schaefer, M.S.E
  • Phone Number: 114 828 645 1026
  • Email: phil@vortant.com

Study Contact Backup

  • Name: Elizabeth M Morgan
  • Phone Number: 212 828 645 1026
  • Email: liz@vortant.com

Study Locations

  • United States
    • North Carolina
      • Weaverville, North Carolina, United States, 28787
        • Vortant Technologies

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

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • AFB "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees

Exclusion Criteria:

  • Any health condition that may affect safety of individual to participate
  • Any physical, mental, or behavioral impairment that would provide more than minimal risk or hindering ability to comprehend the purpose of the device or otherwise to be a potential user of the V-NAV hardware or app.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V-NAV users
Users who try the V-NAV for navigation tasks.
Other: V-NAV indoor navigation prototype
Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
V-NAV effectiveness
Time Frame: 4 weeks
A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
V-NAV usability
Time Frame: 1 day
A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.
1 day

Collaborators and Investigators

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

Sponsor

Vortant Technologies, LLC

Investigators

  • Principal Investigator: Philip R Schaefer, M.S.E, Vortant Technologies, LLC

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-VNAV-2C

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.

Clinical Trials on Blindness and Low Vision

Clinical Trials on V-NAV indoor navigation prototype

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe