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NCT06856746 · ClinicalTrials.gov registry record
Smartphone-based Utility of the Vestibulo-ocular Reflex
A clinical trial, sponsored by University of Virginia.
- Completed
- Registry status
- 35
- Enrollment target
NCT06856746: Completed study, sponsored by University of Virginia.
NCT06856746 is a clinical trial that has completed, run by University of Virginia. The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06856746 has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
Study Summary
The goal of this observational study is to evaluate whether a novel smartphone-based (mHealth) application can accurately assess gaze stability and vestibulo-ocular reflex (VOR) function in adults with vestibular dysfunction. This pilot clinical ststudy includes adult participants with and without unilateral peripheral vestibular dysfunction to determine the feasibility of a mobile-based assessment of gaze stabilization. The main questions it aims to answer are: 1. Can a prototype mHealth application accurately measure outcomes associated with standard dynamic gaze stabilization tests (e.g., static visual acuity, perception time, and maximal head velocity measurements)? 2. How well does a prototype mHealth application identify patients with unilateral peripheral vestibular dysfunction when compared to healthy volunteers? 3. Does a prototype mHealth application differ in identifying patients with unilateral peripheral vestibular dysfunction when compared to a commercially-available computer system that uses a gold-standard head-mounted sensor for gaze stabilization testing (GST)? Participants will: Perform the well-established GST protocol using a commercially-available computer system that uses a gold-standard head-mounted sensor Perform the well-established GST protocol a novel mHealth application The following outcomes will be measured: 1. Standard visual acuity (SVA): The smallest readable target based on the user's best-aided vision 2. A perception time test (PTT): The shortest time a target can be accurately identified 3. A dynamic gaze stability test (GST): The maximal head velocity at which a patient can accurately identify the orientation of a presented visual target This pilot clinical study will provide evidence to further support the use of mobile technology as a low-cost, accessible alternative for vestibular function assessment, particularly for patients in resource-limited settings.
Primary Outcome
The mVOR application is expected to be able to distinguish the direction and peak velocity of head rotation as well as the consistency of gaze fixation. The primary outcome measure for this system is the "GST score", which is recorded as the maximum head velocity (in degrees/s) while maintaining visual acuity, a measure of gaze stabilization or dynamic visual. This clinical measure of vestibular function will be compared to a commercially available, in-office system (Bertex, Inc) that utilizes t
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2025-04-21 |
| Est. Completion | 2025-07-30 |
What the finished NCT06856746 record still lists
NCT06856746 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT06856746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06856746 about?
NCT06856746 is a clinical study titled "Smartphone-based Utility of the Vestibulo-ocular Reflex". The goal of this observational study is to evaluate whether a novel smartphone-based (mHealth) application can accurately assess gaze stability and vestibulo-ocular reflex (VOR) function in adults with vestibular dysfunction. This pilot clinical ststudy includes adult participants with and without u...
What is the current status of trial NCT06856746?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2025-04-21. Estimated completion is 2025-07-30.
Who is sponsoring clinical trial NCT06856746?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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