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

Sponsor

Vortant Technologies, LLC (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05647694

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blindness and Low Vision	Other: V-NAV indoor navigation prototype	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants will compare the value of the prototype app to their previous navigational experience without the app.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.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

V-NAV effectiveness [4 weeks]
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 [1 day]
A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Vortant Technologies, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vortant Technologies, LLC

ClinicalTrials.gov Identifier:

NCT05647694

Other Study ID Numbers:

NEI-VNAV-2C

First Posted:

Dec 12, 2022

Last Update Posted:

Dec 12, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vortant Technologies, LLC

blindness, indoor navigation

Additional relevant MeSH terms:

Blindness

Vision, Low

Study Results

No Results Posted as of Dec 12, 2022