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
About this trial
This is an interventional other trial for Blindness and Low Vision focused on measuring blindness, indoor navigation
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.
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
NCT ID
NCT05647694
First Posted
November 29, 2022
Last Updated
December 9, 2022
Sponsor
Vortant Technologies, LLC
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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