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

Dizziness Clinical Trial

Official title:

Quantification of the Effect of the OtoBand, a Non-invasive Vestibular Masker, on Objective Measures of Vertigo and Dizziness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157399
• Other study ID #: OLith10302
• Status: Completed
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: Otolith Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

In this study, the investigators will assay the efficacy of the OtoBand in participants with vertigo and dizziness. The OtoBand will be given to participants with vertigo and dizziness in patients with vestibular dysfunction. Participants will be recruited from patients who present at the Dizziness and Vertigo Institute of Los Angeles and for whom the Principal Investigators recommend a course of vestibular rehabilitation therapy. The OtoBand will be set at either a normal power (effective) or low power (lower than the power level thought to be effective, placebo device). Participants will not know if they are receiving receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.

This study seeks to determine if, in patients going to the Dizzy and Vertigo Institute of Los Angeles for vestibular rehabilitation therapy, objective measures of dizziness and vertigo are significantly changed by wearing the OtoBand.

Potential changes will be measured in the following tests:

• Subjective Visual Vertical (SVV),

• Sinusoidal Harmonic Acceleration (SHA), also known as rotary chair test

• Spontaneous Nystagmus

In this current protocol, 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 primary endpoint of the study is to determine the change(s) induced by the OtoBand in objective measures of vestibular symptoms.

The secondary endpoints of the study include:

• Participant's questionnaire as to which level the participant believes they used first and second (sham setting vs therapeutic setting);

• Measure whether Migraine and Vestibulopathy patients experience higher benefits from a given power level as measured by objective tests (SVV, SHAs and spontaneous nystagmus);

• Measure whether Migraine and Vestibulopathy patients experience any benefit from the placebo setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 1, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dizziness
• Labyrinthitis
• Neuritis
• Vertigo
• Vestibular Migraine
• Vestibular Neuritis
• Vestibular Neuronitis

Intervention

Device:
• Otoband
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.
• Placebo 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.

Locations

Country	Name	City	State
United States	Dizzy and Vertigo Institute of Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Otolith Labs	Dizzy and Vertigo Institute of Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Participant's questionnaire as to which power level they believe were sham setting vs therapeutic setting	Compare participants' estimation of which device provided the most benefits, to the improvement in VOR gain measured during sinusoidal harmonic accelerations (SHAs).	Within 60 minute trial period.
Secondary	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)	Measure statistically significant changes in VOR gain as measured from Sinusoidal Harmonic Accelerations (SHAs) and spontaneous nystagmus, as a function of the OtoBand's power level and as a function of the participant's condition (vestibular migraine vs vestibulopathy)	Within 60 minute trial period.
Secondary	Determine change in objective measures of vestibular symptoms, namely change in residual nystagmus following SHAs, as a function of experimental condition.	Following sinusoidal harmonic accelerations (SHAs) in the rotary chair, we measure residual eye movements (nystagmus) for one minute at rest. The amplitude and frequency of these eye movements will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the nystagmus as a function of experimental condition.	Within 60 minute trial period.