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

Blindness and Low Vision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05647694
• Other study ID #: NEI-VNAV-2C
• Status: Suspended
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Vortant Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 16
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blindness
• Blindness and Low Vision
• Vision, Low

Intervention

Other:
• V-NAV indoor navigation prototype
Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.

Locations

Country	Name	City	State
United States	Vortant Technologies	Weaverville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Vortant Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	V-NAV effectiveness	A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.	4 weeks
Secondary	V-NAV usability	A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.	1 day