Vestibulo-Ocular Reflex (VOR) DysfunctionNCT06856746
Smartphone-based Utility of the Vestibulo-ocular Reflex
An observational study of Vestibulo-Ocular Reflex (VOR) Dysfunction and Vestibular Function Tests, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibulo-Ocular Reflex (VOR) Dysfunction, Vestibular Function Tests, Vestibular Function Disorder
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 30 Jul 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample of healthy volunteers employed by or affiliated with the University of Virginia; a convenience sample established patients of the University of Virginia health system who meet study criteria to be subjects in unilateral peripheral vestibular dysfunction (UVD) group
Who may be able to join
- Adults 18 years or older
- Able to provide informed consent
- Normal or corrected-to-normal vision (e.g., with glasses or contact lenses)
- Able to sit upright and follow instructions for the duration of the test (~2-3 hours)
- No known contraindications to head movement (e.g., musculoskeletal or neurological conditions that prevent safe head rotation)
- For vestibular dysfunction group: Participants must have a diagnosed vestibular disorder (e.g., vestibular hypofunction, vestibular neuritis, Meniere's disease, labyrinthitis, vestibular migraine, or post-concussive dizziness)
- For control group: Participants must be free from diagnosed vestibular disorders and report no history of balance issues, dizziness, or vertigo
Who cannot join
- Severe visual impairment that cannot be corrected with glasses or contact lenses
- Cognitive impairment or neurological conditions that could interfere with following instructions (e.g., moderate to severe dementia, uncontrolled seizures, severe traumatic brain injury)
- Severe musculoskeletal or orthopedic conditions affecting the neck or cervical spine that prevent safe head movement (e.g., cervical fusion, severe arthritis, neck instability)
- Acute illness or infection at the time of testing (e.g., flu, COVID-19, severe sinus infection that may impact vestibular function)
- Recent vestibular or neurological surgery (<6 months prior to study participation)
- Severe hearing loss that prevents understanding spoken instructions
- History of stroke or progressive neurological disorders affecting balance or gaze stability (e.g., Parkinson's disease, multiple sclerosis, ALS)
- Use of vestibular suppressants (e.g., meclizine, diazepam, scopolamine) within 24 hours of testing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Viginia
Charlottesville, Virginia, 22903
About this study
Official title: Smartphone-based Utility of the Vestibulo-ocular Reflex: a Pilot Clinical Study
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:
Read more
- 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)?
- How well does a prototype mHealth application identify patients with unilateral peripheral vestibular dysfunction when compared to healthy volunteers?
- 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:
- Standard visual acuity (SVA): The smallest readable target based on the user's best-aided vision
- A perception time test (PTT): The shortest time a target can be accurately identified
- 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.
Read the detailed description
Background \& Rationale Vestibular dysfunction is a common condition affecting over a third of U.S. adults over the age of 40. It significantly increases the risk of falls, especially in those experiencing dizziness, where the odds of falling are increased 12-fold. Current best practices recommend vestibular rehabilitation, which includes gaze stability exercises designed to improve balance and reduce fall risk. However, many individuals, particularly those relying on home-based therapy or telehealth, face challenges in accessing objective assessments of their vestibulo-ocular reflex (VOR) contribution to gaze stabilization.
As telehealth has expanded rapidly in response to the COVID-19 pandemic, there is an increasing need for remote, real-time VOR teleassessments that can provide clinicians and patients with quantifiable, velocity-specific gaze stability data. While some computer-based remote VOR assessment tools exist, they often suffer from limitations in user satisfaction and accuracy. The Gaze Stabilization Test (GST), developed by Goebel et al., provides clinicians with velocity-specific data associated with the VOR's contribution to gaze stabilization. However, this test is typically performed in a clinical setting with specialized equipment, limiting access for many patients.
This pilot clinical study aims to validate a mHealth application (mVOR) prototype as a low-cost, accessible alternative to traditional VOR assessments. By leveraging the head- and eye-tracking capabilities of modern smartphones, this proof-of-concept prototype seeks to provide a novel, mobile-based framework for measuring visual acuity, head velocity, and gaze estimation in patients undergoing vestibular rehabilitation.
Study Objectives \& Hypothesis
Primary Objectives:
To determine whether a prototype mHealth application can accurately assess static visual acuity, perception time, and maximal head velocity in individuals with unilateral peripheral vestibular dysfunction (UVD).
To compare the accuracy of the mVOR application against a commercially-available, in-office GST system that identifies patients with UVD.
Hypothesis:
The investigators hypothesize that by using the native head and eye-tracking capabilities of smartphones, one can obtain gaze stability (GST) measurements using a mobile platform that provides visual acuity and velocity-specific data comparable to a commercially-available, in-office GST system.
If validated, the mVOR could serve as an platform for effective, low-cost alternatives for telemonitoring vestibular function and enhancing remote rehabilitation programs for individuals with balance disorders.
Anticipated sample size: 50 (25 healthy volunteers and 25 patients with UVD)
Data Analysis
Within-group comparisons:
Paired t-tests or Wilcoxon Signed-Rank tests (depending on data distribution) will compare participants' GST and mVOR scores.
Between-group comparisons:
Independent t-tests or Mann-Whitney U tests will compare UVD vs. healthy volunteer group.
ROC Curve Analysis:
Receiver Operating Characteristic (ROC) curves will assess the accuracy of mVOR vs. computerized GST in distinguishing patients with UVD
Potential Benefits \& Clinical Significance Increased Accessibility: The mVOR app provides an affordable, mobile alternative to in-office based GST system, expanding access to vestibular rehabilitation.
Telehealth \& Home Monitoring: This study could support remote vestibular assessments, particularly for patients in rural or underserved communities.
Clinical Validation: If the mVOR performs comparably to the in-office based GST, it may be integrated into clinical practice as a validated tool for assessing vestibular function.
- Conditions
- Vestibulo-Ocular Reflex (VOR) Dysfunction, Vestibular Function Tests, Vestibular Function Disorder, mHealth Application
- Keywords
- Vestibular Dysfunction, Gaze Stabilization Test (GST), Vestibulo-Ocular Reflex (VOR), mHealth Vestibular Testing
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral vestibular dysfunction (UVD) | This group includes with unilateral peripheral vestibular dysfunction identified via the Electronic Medical Record (EMR) and meet the following study criteria: Inclusion criteria: * > 18 y/o * Willingness and ability to comply with scheduled visits and study procedures. * History of unilateral vestibular dysfunction (>49% asymmetry on bithermal binaural caloric testing) OR surgical ablation of vestibular end organ or nerve, such as via resection of unilateral vestibular schwannoma or labyrinthectomy) Exclusion criteria: * No history of vestibular dysfunction * History of underlying cervical musculoskeletal disease that restricts the neck * History of cervical dysfunction that prevented them from moving their head, severe visual impairment or blind spots in the field, or central nervous system disorder | |
| Healthy volunteers | This group includes with those without a history of unilateral peripheral dysfunction (UVD) and meet the following study criteria: Inclusion criteria: * 18 y/o * Willingness and ability to comply with scheduled visits and study procedures Exclusion criteria: * History of vestibular dysfunction * History of uncorrected vision * History of underlying cervical musculoskeletal disease that restricts the neck * History of cervical dysfunction that prevented them from moving their head, severe visual impairment or blind spots in the field, or central nervous system disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of mVOR mHealth application system in assessing gaze stability
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 the GST protocol and a head-mounted sensory and is often used in Dizziness and Balance Centers around the world for vestibular rehabilitation.
Primary variable analysis will include standard descriptive statistics and within-group and between in-group (UVD vs healthy volunteer) pairwise comparisons. ROC and AUC curves will be generated to evaluate the sensitivity and specificity of the mVOR application in distinguishing vestibular dysfunction from healthy controls.
Measured: Immediately after testing (single session, approximately 2-3 hour per participant)
Secondary outcomes (2)
Assessment of static visual acuity
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. In order to do this, per the gaze stabilization test (GST) protocol, the mHealth application must first determine a user's visual acuity with head kept still. This is called the static visual acuity (SVA) and is recorded in logMAR units.
Primary variable analyses will include standard descriptive statistic and will also be compared to the same outcome measure obtained from a commercially available, in-office GST system.
Measured: Immediately during (2-3 hours) and following testing
Assessment of visual perception time
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. In order to do this, per the gaze stabilization test (GST) protocol, the mHealth application .(following determination of the static visual acuity [SVA]), must determine the minimum time at which a user can correctly identify a presented target with head kept still. This outcome measure is called the visual perception time (VPT) and is recorded in milliseconds (msec). Primary variable analyses will include standard descriptive statistic and will also be compared to the same outcome measure obtained from a commercially available, in-office GST system.
Measured: Immediately during (2-3 hours) and following testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start21 Apr 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vestibulo-Ocular Reflex (VOR) DysfunctionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Bradley Kesser, MD, University of Virginia
- Investigators
- Adam Thompson-Harvey, MD, Principal investigator, University of VirginiaBradley Kesser, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856746
- Sponsor's protocol ID
- HSR230265
- Other IDs
- 1R41DC022209-01
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared with other researchers upon request. The following data will be made available: Demographic Information (age, gender, group allocation - control vs. vestibular dysfunction) Outcome Measures (static visual acuity in logMAR, perception time in ms, maximum head velocity in deg/s) Comparison Data (mVOR mHealth application GST results vs. in-office computerized GST results) Statistical Analysis Outputs (correlation coefficients, ROC curve data, Bland-Altman plots) Data will be shared in compliance with applicable privacy laws and regulations, ensuring that all information remains de-identified and anonymized. Requests for data access will be reviewed by the study investigators and granted for research purposes related to vestibular assessment, gaze stabilization, and telehealth applications. Researchers interested in accessing the data may contact the principal investigator.
Publications
Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
PubMed 7814786Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
PubMed 2317323Huang K, Sparto PJ, Kiesler S, Siewiorek DP, Smailagic A. iPod-based in-home system for monitoring gaze-stabilization exercise compliance of individuals with vestibular hypofunction. J Neuroeng Rehabil. 2014 Apr 21;11:69. doi: 10.1186/1743-0003-11-69.
PubMed 24746068Chen PY, Hsieh WL, Wei SH, Kao CL. Interactive wiimote gaze stabilization exercise training system for patients with vestibular hypofunction. J Neuroeng Rehabil. 2012 Oct 9;9:77. doi: 10.1186/1743-0003-9-77.
PubMed 23043886Goebel JA, Tungsiripat N, Sinks B, Carmody J. Gaze stabilization test: a new clinical test of unilateral vestibular dysfunction. Otol Neurotol. 2007 Jan;28(1):68-73. doi: 10.1097/01.mao.0000244351.42201.a7.
PubMed 17106431Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
PubMed 20588090Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
PubMed 26913496Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
PubMed 19468085
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-based Utility of the Vestibulo-ocular Reflex: a Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT06856746
- Acronym / sponsor ID
- HSR230265
- Conditions
- Vestibulo-Ocular Reflex (VOR) Dysfunction, Vestibular Function Tests, Vestibular Function Disorder, mHealth Application
- Keywords
- Vestibular Dysfunction, Gaze Stabilization Test (GST), Vestibulo-Ocular Reflex (VOR), mHealth Vestibular Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 4 Mar 2025 (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 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:
- 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)?
- How well does a prototype mHealth application identify patients with unilateral peripheral vestibular dysfunction when compared to healthy volunteers?
- 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:
- Standard visual acuity (SVA): The smallest readable target based on the user's best-aided vision
- A perception time test (PTT): The shortest time a target can be accurately identified
- 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.
Detailed description
Background \& Rationale Vestibular dysfunction is a common condition affecting over a third of U.S. adults over the age of 40. It significantly increases the risk of falls, especially in those experiencing dizziness, where the odds of falling are increased 12-fold. Current best practices recommend vestibular rehabilitation, which includes gaze stability exercises designed to improve balance and reduce fall risk. However, many individuals, particularly those relying on home-based therapy or telehealth, face challenges in accessing objective assessments of their vestibulo-ocular reflex (VOR) contribution to gaze stabilization.
As telehealth has expanded rapidly in response to the COVID-19 pandemic, there is an increasing need for remote, real-time VOR teleassessments that can provide clinicians and patients with quantifiable, velocity-specific gaze stability data. While some computer-based remote VOR assessment tools exist, they often suffer from limitations in user satisfaction and accuracy. The Gaze Stabilization Test (GST), developed by Goebel et al., provides clinicians with velocity-specific data associated with the VOR's contribution to gaze stabilization. However, this test is typically performed in a clinical setting with specialized equipment, limiting access for many patients.
This pilot clinical study aims to validate a mHealth application (mVOR) prototype as a low-cost, accessible alternative to traditional VOR assessments. By leveraging the head- and eye-tracking capabilities of modern smartphones, this proof-of-concept prototype seeks to provide a novel, mobile-based framework for measuring visual acuity, head velocity, and gaze estimation in patients undergoing vestibular rehabilitation.
Study Objectives \& Hypothesis
Primary Objectives:
To determine whether a prototype mHealth application can accurately assess static visual acuity, perception time, and maximal head velocity in individuals with unilateral peripheral vestibular dysfunction (UVD).
To compare the accuracy of the mVOR application against a commercially-available, in-office GST system that identifies patients with UVD.
Hypothesis:
The investigators hypothesize that by using the native head and eye-tracking capabilities of smartphones, one can obtain gaze stability (GST) measurements using a mobile platform that provides visual acuity and velocity-specific data comparable to a commercially-available, in-office GST system.
If validated, the mVOR could serve as an platform for effective, low-cost alternatives for telemonitoring vestibular function and enhancing remote rehabilitation programs for individuals with balance disorders.
Anticipated sample size: 50 (25 healthy volunteers and 25 patients with UVD)
Data Analysis
Within-group comparisons:
Paired t-tests or Wilcoxon Signed-Rank tests (depending on data distribution) will compare participants' GST and mVOR scores.
Between-group comparisons:
Independent t-tests or Mann-Whitney U tests will compare UVD vs. healthy volunteer group.
ROC Curve Analysis:
Receiver Operating Characteristic (ROC) curves will assess the accuracy of mVOR vs. computerized GST in distinguishing patients with UVD
Potential Benefits \& Clinical Significance Increased Accessibility: The mVOR app provides an affordable, mobile alternative to in-office based GST system, expanding access to vestibular rehabilitation.
Telehealth \& Home Monitoring: This study could support remote vestibular assessments, particularly for patients in rural or underserved communities.
Clinical Validation: If the mVOR performs comparably to the in-office based GST, it may be integrated into clinical practice as a validated tool for assessing vestibular function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral vestibular dysfunction (UVD) | – | –This group includes with unilateral peripheral vestibular dysfunction identified via the Electronic Medical Record (EMR) and meet the following study criteria: Inclusion criteria: * > 18 y/o * Willingness and ability to comply with scheduled visits and study procedures. * History of unilateral vestibular dysfunction (>49% asymmetry on bithermal binaural caloric testing) OR surgical ablation of vestibular end organ or nerve, such as via resection of unilateral vestibular schwannoma or labyrinthectomy) Exclusion criteria: * No history of vestibular dysfunction * History of underlying cervical musculoskeletal disease that restricts the neck * History of cervical dysfunction that prevented them from moving their head, severe visual impairment or blind spots in the field, or central nervous system disorder |
| Healthy volunteers | – | –This group includes with those without a history of unilateral peripheral dysfunction (UVD) and meet the following study criteria: Inclusion criteria: * 18 y/o * Willingness and ability to comply with scheduled visits and study procedures Exclusion criteria: * History of vestibular dysfunction * History of uncorrected vision * History of underlying cervical musculoskeletal disease that restricts the neck * History of cervical dysfunction that prevented them from moving their head, severe visual impairment or blind spots in the field, or central nervous system disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of healthy volunteers employed by or affiliated with the University of Virginia; a convenience sample established patients of the University of Virginia health system who meet study criteria to be subjects in unilateral peripheral vestibular dysfunction (UVD) group
Key inclusion criteria (7 listed)
- Adults 18 years or older
- Able to provide informed consent
- Normal or corrected-to-normal vision (e.g., with glasses or contact lenses)
- Able to sit upright and follow instructions for the duration of the test (~2-3 hours)
- No known contraindications to head movement (e.g., musculoskeletal or neurological conditions that prevent safe head rotation)
Key exclusion criteria (8 listed)
- Severe visual impairment that cannot be corrected with glasses or contact lenses
- Cognitive impairment or neurological conditions that could interfere with following instructions (e.g., moderate to severe dementia, uncontrolled seizures, severe traumatic brain injury)
- Severe musculoskeletal or orthopedic conditions affecting the neck or cervical spine that prevent safe head movement (e.g., cervical fusion, severe arthritis, neck instability)
- Acute illness or infection at the time of testing (e.g., flu, COVID-19, severe sinus infection that may impact vestibular function)
- Recent vestibular or neurological surgery (<6 months prior to study participation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of mVOR mHealth application system in assessing gaze stability
Time frame: Immediately after testing (single session, approximately 2-3 hour per participant)
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 the GST protocol and a head-mounted sensory and is often used in Dizziness and Balance Centers around the world for vestibular rehabilitation. Primary variable analysis will include standard descriptive statistics and within-group and between in-group (UVD vs healthy volunteer) pairwise comparisons. ROC and AUC curves will be generated to evaluate the sensitivity and specificity of the mVOR application in distinguishing vestibular dysfunction from healthy controls.
2 secondary outcomes
Assessment of static visual acuity
Time frame: Immediately during (2-3 hours) and following testing
Assessment of visual perception time
Time frame: Immediately during (2-3 hours) and following testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Background: PubMed 7814786Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
- Background: PubMed 2317323Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
- Background: PubMed 24746068Huang K, Sparto PJ, Kiesler S, Siewiorek DP, Smailagic A. iPod-based in-home system for monitoring gaze-stabilization exercise compliance of individuals with vestibular hypofunction. J Neuroeng Rehabil. 2014 Apr 21;11:69. doi: 10.1186/1743-0003-11-69.
- Background: PubMed 23043886Chen PY, Hsieh WL, Wei SH, Kao CL. Interactive wiimote gaze stabilization exercise training system for patients with vestibular hypofunction. J Neuroeng Rehabil. 2012 Oct 9;9:77. doi: 10.1186/1743-0003-9-77.
- Background: PubMed 17106431Goebel JA, Tungsiripat N, Sinks B, Carmody J. Gaze stabilization test: a new clinical test of unilateral vestibular dysfunction. Otol Neurotol. 2007 Jan;28(1):68-73. doi: 10.1097/01.mao.0000244351.42201.a7.
- Background: PubMed 20588090Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
- Background: PubMed 26913496Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
- Background: PubMed 19468085Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared with other researchers upon request. The following data will be made available: Demographic Information (age, gender, group allocation - control vs. vestibular dysfunction) Outcome Measures (static visual acuity in logMAR, perception time in ms, maximum head velocity in deg/s) Comparison Data (mVOR mHealth application GST results vs. in-office computerized GST results) Statistical Analysis Outputs (correlation coefficients, ROC curve data, Bland-Altman plots) Data will be shared in compliance with applicable privacy laws and regulations, ensuring that all information remains de-identified and anonymized. Requests for data access will be reviewed by the study investigators and granted for research purposes related to vestibular assessment, gaze stabilization, and telehealth applications. Researchers interested in accessing the data may contact the principal investigator.
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.
Adam Thompson-Harvey, MD principal investigator
University of Virginia
Bradley Kesser, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibulo-Ocular Reflex (VOR) Dysfunction and Vestibular Function Tests, run by University of Virginia 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 23 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of mVOR mHealth application system in assessing gaze stability (time frame: Immediately after testing (single session, approximately 2-3 hour per participant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856746, which also lists 8 linked publications.
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 23 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.