Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness

NCT05157399 | Completed DMC

• 1 other identifier: OLith10302
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders. This study seeks to quantify the effect of the study device, the OtoBand, on objective measures of dizziness and vertigo in patients with vestibular dysfunction. The study will be conducted at a single-site and will be a blinded, randomized, placebo-controlled design in which participants do not know if they are receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.

Conditions

Dizziness; Vertigo; Vestibular Migraine; Vestibular Neuritis; Labyrinthitis

Keywords

Vestibular weakness

Outcome Measures

Primary Outcomes (2)

• Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.

  We measure the Gain of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean Gain across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the Gain as a function of experimental condition.

  Within 60 minute trial period.

• Determine change in objective measures of vestibular symptoms, namely change in VOR Phase induced by the OtoBand.

  We measure the Phase of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean phase lag across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the phase lag as a function of experimental condition.

  Within 60 minute trial period.

Secondary Outcomes (3)

• Participant's questionnaire as to which power level they believe were sham setting vs therapeutic setting

  Within 60 minute trial period.

• Measure whether Vestibular Migraine and Vestibulopathy patients experience higher benefits from a low vs high bone conduction levels as measured by outcomes of objective tests (SHAs and spontaneous nystagmus)

  Within 60 minute trial period.

• Determine change in objective measures of vestibular symptoms, namely change in residual nystagmus following SHAs, as a function of experimental condition.

  Within 60 minute trial period.

Study Arms (3)

OtoBand Efficacy on Vertigo and Dizziness

EXPERIMENTAL

During the single site visit, participants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand will be set to 92dB or 98dB bone conduction level (Re: 1 Dyne). The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements.

Device: Otoband

Placebo Device Efficacy on Vertigo and Dizziness

PLACEBO COMPARATOR

Participants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand set to a bone conduction level 10dB lower than the level used in the experimental condition. Once fitted with the Otoband, participants will undergo the vestibular battery test. The investigator will record the outcome measurements.

Device: Placebo Device

No Device

NO INTERVENTION

Participants will wear the OtoBand, but turned off, to collect baseline data. This will be randomized. The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements.

Interventions

Otoband DEVICE

Participants with Dizziness and Vertigo 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.

OtoBand Efficacy on Vertigo and Dizziness

Placebo Device DEVICE

Participants with Dizziness and Vertigo 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.

Placebo Device Efficacy on Vertigo and Dizziness

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vertigo that has been present for at least 90 days, constant or predictable with attacks at least twice a week.
• Classified as having vertigo from one of the following vestibulogenic vertigo conditions:
• Migraine Associated Vertigo, aka Vestibular Migraine
• Chronic Unilateral Vestibulopathy in one of three forms: Persistent Postural-Perceptual Dizziness (aka 3PD), Vestibular Neuritis, Labyrinthitis
• Score \> 35 on Dizziness Handicap Inventory
• Willingness to cease vestibular suppressants for 24h prior to study.

You may not qualify if:

• Vertigo that first presented within the last 90 days
• Skull base surgery within the last 90 days
• Any skull implant (cochlear implant, bone conduction implant, DBS)
• Resolved vestibular dysfunction by the time of study appointment
• History of head injury within the last 6 months or currently suffering the effects of a head injury
• History of diagnosed untreated neuropsychiatric disorders (hypochondriasis, major depression, schizophrenia)
• Prior documented neurodegenerative disorders of hearing and balance including:
• Multiple sclerosis
• Vestibular schwannoma
• History of Cerebrovascular disorders
• History of ear operation other than myringotomy (tube placement)
• Vitreous detachment of the retina (floaters) in the previous 90 days
• Presence of severe aphasia, and individuals who cannot provide informed consent

Sponsors & Collaborators

• Otolith Labs: lead
• Dizzy and Vertigo Institute of Los Angeles: collaborator

Study Sites (1)

Dizzy and Vertigo Institute of Los Angeles

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Dizziness; Vertigo; Vestibular Neuronitis; Labyrinthitis

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Cranial Nerve Diseases; Otitis

Study Officials

• Brooke Pearce, AuD

  Dizzy and Vertigo Institute of Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants with vertigo and dizziness will be asked to participate in the study. Subjects that give consent will be entered into the study and three conditions (sham, therapeutic and no device) will be tested within an hour in a randomized sequence, with the OtoBand remaining in place throughout (turned off in the "no device" condition). The subjects will complete a Participant Questionnaire following the testing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 15, 2021
• Study Start: November 4, 2021
• Primary Completion: August 9, 2022
• Study Completion: September 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)