Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy

Efficacy of a Non-invasive Vestibular System Masking for the Abortive Treatment of Vertigo for Patients With Acute Unilateral Vestibulopathy (AUV)

Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Acute unilateral vestibulopathy (AUV) is easy to diagnose and is commonly treated with physical therapy exercises called vestibular rehabilitation. But due to the discomfort experienced during AUV, patients can't usually comply with the treatment plan prescribed by their healthcare provider.

In this study, the investigators propose the use of an adjuvant device, the OtoBand, to improve balance, gait, reduce vertigo, and nausea in participants with AUV. Participants enrolled will undergo three vestibular tests batteries: one baseline, one with the OtoBand set at an effective power, and one with the placebo device set at low power. Neither participants nor investigator will know which device is effective and which is placebo. The OtoBand will be set at two different effective power levels. Which power level the participant will receive is randomized and unknown to the participant or investigator.

Study Overview

• Status: Suspended
• Conditions: Nausea; Dizziness
• Intervention / Treatment: Device: Otoband; Device: Placebo Device

Detailed Description

Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living. At the current time, the mainstay of therapy for many vestibular disorders is a physical therapy called vestibular rehabilitation. While usually highly effective, this therapy is time consuming and not universally effective, in part because of inconsistent subject compliance. The use of adjuvant devices to speed recovery has been studied but very few devices have proved beneficial; the few that have shown benefit only work in special populations and are large units that cost several million dollars.

The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders. To date, the device has only been systematically tested on healthy volunteers and has been shown to improve vertigo associated to motion sickness and virtual reality device use.

In this study, the investigators will assay the efficacy of the OtoBand on participants with acute unilateral vestibulopathy (AUV). The OtoBand will be given to participants with AUV for use during vestibular test batteries. The OtoBand will be set at either a normal power (effective) or low power (6 decibels lower than normal power, placebo device). There are two effective power levels, which will be randomly assigned to each of the participants. Outcomes will be assessed by the investigator by a set of vestibular tests while the participant uses the OtoBand or placebo device. Participants vestibular disorder outcomes will be compared between OtoBand and placebo device to:

1. Determine if participants treated with OtoBand achieve instantaneous effectiveness in reducing vestibular symptoms.
2. Determine if participants treated with the OtoBand at higher power levels experience higher benefits.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subject between the ages of 18-70 with an acute unilateral vestibulopathy as characterized by the following

• Acute onset vertigo that lasts at least 6 hours within the previous 2 weeks.
• A feeling of unsteadiness or feeling off balance for at least 48 hours after conclusion of vertigo
• Confirmed unilateral vestibulopathy on head rotation test or caloric test

Exclusion Criteria:

1. Resolved vestibular hypofunction by the time of visit to clinic
2. History of head injury within the last six months or currently suffering the effects of a head injury
3. Presence of severe aphasia
4. History of diagnosed, untreated neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
5. Documented neurodegenerative disorders

6. Prior disorders of hearing and balance including:

   1. Ménière's disease
   2. Multiple sclerosis
   3. Vestibular neuritis (prior resolved episode)
   4. Vestibular schwannoma
   5. Sudden sensorineural hearing loss
7. History of Cerebrovascular disorders
8. History of ear operation other than myringotomy (tube placement) in the past
9. Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
10. Individuals who cannot provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Otoband efficacy on AUV; Participants will wear the Otoband during the single site visit against the skin, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. Half the participants will be given the Otoband at power level 96db and half will be given the Otoband at power level 98db (all bone conduction levels re:1dyne). This will be randomized and neither the participant nor the investigator will know what power level the Otoband is set at. The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements.	Device: Otoband; Participants with AUV will wear the Otoband set at normal power (effective) during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
Placebo Comparator: Placebo device efficacy on AUV; Participants will wear the placebo device during the single site visit against the skin, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. The placebo device will be set at a power level of 90db (bone conduction level re:1dyne). Neither the participant nor the investigator will know that this device is the placebo device. The participants will be fitted with the placebo device and will undergo the vestibular battery test. The investigator will record the outcome measurements.	Device: Placebo Device; Participants with AUV will wear the placebo device set at low power during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vestibular function as measured by Functional Gait Assessment	Measure statistically significant change in postural stability in acute vestibular patients, by obtaining the participants' scores on the Functional Gait Assessment (FGA). An ANOVA will be performed on the FGA scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level.	Three tests over 30 minutes - During 1-day visit at the University of Miami Health System.
Change in vestibular function as measured by Dizziness Handicap Inventory	Measure statistically significant change in perception of dizziness by administering the Dizziness Handicap Inventory (DHI) immediately following the gait tasks of the Functional Gait Assessment. An ANOVA comparison will be performed between the set of DHI scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level.	Three times immediately following FGA testing - During 1-day visit at the University of Miami Health System.
Change in vestibular function as measured by I-PAS testing	Measure statistically significant change in vestibular function and reduction in vestibular symptoms, as measured from the participant's score on the I-PAS test battery. The I-PAS consists in "video Head Impulse Testing" (vHIT) and the "Oculomotor, Vestibular, and Reaction Time" testing (OVRT). An ANOVA comparison will be performed between the set of scoresI-PAS scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level.	Three tests over one hour - During the 1-day visit at the University of Miami Health System.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential effect of bone conduction level on vestibular improvements	The trial has two groups of participants: half of the participants are tested with the OtoBand set at a bone conduction level found to be optimally effective in healthy subjects, and half of the participants are tested with the OtoBand set at a higher bone conduction level. A statistical test will be used to determine whether acute unilateral vestibulopathy participants, as a group, experience higher or lower benefits from the higher bone conduction power level, using the measures of the three primary outcomes (FGA, DHI, I-PAS).	Summary data at end of study (1 year)

Collaborators and Investigators

• Sponsor: Otolith Labs

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Sensation Disorders; Dizziness
• Other Study ID Numbers: OLith10501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No