Smartphone-based Utility of the Vestibulo-ocular Reflex

NCT06856746 | Completed

• 2 other identifiers: HSR2302651R41DC022209-01
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.How well does a prototype mHealth application identify patients with unilateral peripheral vestibular dysfunction when compared to healthy volunteers?
3. 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)?
4. 4.Standard visual acuity (SVA): The smallest readable target based on the user's best-aided vision
5. 5.A perception time test (PTT): The shortest time a target can be accurately identified
6. 6.A dynamic gaze stability test (GST): The maximal head velocity at which a patient can accurately identify the orientation of a presented visual target

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after testing (single session, approximately 2-3 hour per participant)

Secondary Outcomes (2)

• Assessment of static visual acuity

  Immediately during (2-3 hours) and following testing

• Assessment of visual perception time

  Immediately during (2-3 hours) and following testing

Other Outcomes (8)

• Age

  Prior to study enrollment and immediately after testing (single session, approximately 2-3 hour per participant)

• Gender

  Prior to study enrollment and immediately after testing (single session, approximately 2-3 hour per participant)

• Dizziness Handicap Inventory (DHI) score

  Immediately after testing (single session, approximately 2-3 hour per participant)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Viginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (8)

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  PMID: 7814786 BACKGROUND

• Jacobson 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.

  PMID: 2317323 BACKGROUND

• Huang 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.

  PMID: 24746068 BACKGROUND

• Chen 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.

  PMID: 23043886 BACKGROUND

• Goebel 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.

  PMID: 17106431 BACKGROUND

• Hall 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.

  PMID: 20588090 BACKGROUND

• Hall 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.

  PMID: 26913496 BACKGROUND

• Agrawal 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.

  PMID: 19468085 BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Adam Thompson-Harvey, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Bradley Kesser, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Vice-Chair

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 4, 2025
• Study Start: April 21, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start Date: Data and supporting information will be available six months after study completion to allow for initial publication of findings. End Date: Data will remain available for at least five years post-publication or as required by funders and institutional policies.
• Access Criteria: Who can access the data? Qualified researchers, academic institutions, and healthcare professionals conducting research related to vestibular function, gaze stabilization, or telehealth applications. What data will be accessible? De-identified individual participant data (IPD), including demographic variables, study outcomes, and comparison data between mVOR mHealth application and in-office computerized GST. Supporting documents such as the study protocol, statistical analysis plan (SAP), clinical study report (CSR), and analytic code for reproducing study results. How to access the data? Researchers must submit a formal data request to the principal investigator. Requests will be reviewed on a case-by-case basis to ensure appropriate research use. Upon approval, access to datasets and supporting information will be provided through a secure data-sharing repository or via institutional agreements.

Locations

US (1)