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OtoBand Efficacy on Vertigo and Dizziness for Vertigo

N/A

Waitlist Available

Led By Brooke Pearce, AuD

Research Sponsored by Otolith Labs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 60 minute trial period.

Summary

This trial tests the OtoBand, a device that sends gentle vibrations through the head, on patients with dizziness and balance issues. It aims to see if these vibrations can help improve their symptoms.

Eligible Conditions

Vertigo
Labyrinthitis
Migraine
Dizziness

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 60 minute trial period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 60 minute trial period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 60 minute trial period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Congenital nystagmus

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)

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: OtoBand Efficacy on Vertigo and DizzinessExperimental Treatment1 Intervention

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.

Group II: No DeviceActive Control1 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.

Group III: Placebo Device Efficacy on Vertigo and DizzinessPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Otoband

2021

N/A

~30

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