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

Primary Purpose

Blindness and Low Vision

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
V-NAV indoor navigation prototype
Sponsored by
Vortant Technologies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Blindness and Low Vision focused on measuring blindness, indoor navigation

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    V-NAV users

    Arm Description

    Users who try the V-NAV for navigation tasks.

    Outcomes

    Primary Outcome Measures

    V-NAV effectiveness
    A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.

    Secondary Outcome Measures

    V-NAV usability
    A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.

    Full Information

    First Posted
    November 29, 2022
    Last Updated
    December 9, 2022
    Sponsor
    Vortant Technologies, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05647694
    Brief Title
    V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool
    Official Title
    V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vortant Technologies, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blindness and Low Vision
    Keywords
    blindness, indoor navigation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Participants will compare the value of the prototype app to their previous navigational experience without the app.
    Masking
    None (Open Label)
    Masking Description
    The use of the app will not be masked.
    Allocation
    N/A
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    V-NAV users
    Arm Type
    Experimental
    Arm Description
    Users who try the V-NAV for navigation tasks.
    Intervention Type
    Other
    Intervention Name(s)
    V-NAV indoor navigation prototype
    Intervention Description
    Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.
    Primary Outcome Measure Information:
    Title
    V-NAV effectiveness
    Description
    A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    V-NAV usability
    Description
    A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Philip R Schaefer, M.S.E
    Phone
    828 645 1026
    Ext
    114
    Email
    phil@vortant.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elizabeth M Morgan
    Phone
    828 645 1026
    Ext
    212
    Email
    liz@vortant.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philip R Schaefer, M.S.E
    Organizational Affiliation
    Vortant Technologies, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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