Blindness and Low VisionNCT05647694
V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool
A study testing V-NAV indoor navigation prototype in people with Blindness and Low Vision, run by Vortant Technologies, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Blindness and Low Vision
- What is being tested?
- V-NAV indoor navigation prototype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AFB "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vortant Technologies
Weaverville, North Carolina, 28787
About this study
Official title: V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation
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.
Read the 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.
- Conditions
- Blindness and Low Vision
- Being tested
- V-NAV indoor navigation prototype
- Keywords
- blindness, indoor navigation
- Medical subject headings
- Blindness, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-NAV indoor navigation prototypeOther
Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.
| Study group | Role | What they receive |
|---|---|---|
| V-NAV users | Experimental | Users who try the V-NAV for navigation tasks. Receives: Other: V-NAV indoor navigation prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
V-NAV effectiveness
A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.
Measured: 4 weeks
Secondary outcomes (1)
V-NAV usability
A measurement of how usable the V-NAV is. Use of e.g., NASA TLX survey.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Why it stopped: Usability issues were identified with the app. Some usability enhancements are being implemented prior to continuing with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blindness and Low VisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will compare the value of the prototype app to their previous navigational experience without the app.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vortant Technologies, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip R Schaefer, M.S.E, Principal investigator, Vortant Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647694
- Sponsor's protocol ID
- NEI-VNAV-2C
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation
- ClinicalTrials.gov ID
- NCT05647694
- Acronym / sponsor ID
- NEI-VNAV-2C
- Conditions
- Blindness and Low Vision
- Keywords
- blindness, indoor navigation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Usability issues were identified with the app. Some usability enhancements are being implemented prior to continuing with the study
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Vortant Technologies, LLCUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will compare the value of the prototype app to their previous navigational experience without the app.
| Arm | Type | Receives |
|---|---|---|
| V-NAV users | Experimental | Other: V-NAV indoor navigation prototypeUsers who try the V-NAV for navigation tasks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- AFB "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-NAV indoor navigation prototypeUsers will use the V-NAV prototype as an augmentation to their indoor navigation activities. | Other | V-NAV users |
Primary outcome
V-NAV effectiveness
Time frame: 4 weeks
A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.
1 secondary outcome
V-NAV usability
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip R Schaefer, M.S.E principal investigator
Vortant Technologies, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-NAV indoor navigation prototype in people with Blindness and Low Vision, run by Vortant Technologies, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
V-NAV effectiveness (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.