Viewing Study NCT05647694


Ignite Creation Date: 2025-12-25 @ 1:33 AM
Ignite Modification Date: 2026-01-07 @ 1:52 AM
Study NCT ID: NCT05647694
Status: SUSPENDED
Last Update Posted: 2024-11-25
First Post: 2022-11-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool
Sponsor: Vortant Technologies, LLC
Organization:

Study Overview

Official Title: V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation
Status: SUSPENDED
Status Verified Date: 2024-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Usability issues were identified with the app. Some usability enhancements are being implemented prior to continuing with the study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: