This study seeks to gather data on the effect of a device, the OtoBand, in participants
who have reported symptoms of vertigo, compared to the effect of using one of two sham
devices. The study is designed to be conducted remotely using video conferencing between
representatives of the manufacturer of the Otoband and participants. In order to comply
with requirements for non-essential contact due to the Covid-19 pandemic there will be no
person to person contact in the study.

Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting

Vertigo

In this phase of this pilot study, a minimum of 20 participants will be enrolled, with up
to 100 participants maximum. This will provide adequately powered pilot data to measure
effect size for the OtoBand and sham devices and to identify different causes of vertigo
for which the OtoBand has a particularly strong effect as measured by the Otolith Vertigo
Assessment Tool. After inclusion/exclusion screening and informed consent is obtained,
potential participants will be assessed using the Dizziness Handicap Inventory (DHI). The
DHI will be completed online.

Potential participants with a DHI score in the appropriate range will be accepted into
the study. These participants will be asked to schedule an online meeting to with the
study coordinator. In this online enrollment meeting, the study coordinator will review
the Informed Consent and confirm other information supplied by the participant online
(inclusion/exclusion) and then make an affirmative decision to enroll or not enroll
participants in the study.

The participants will be randomly assigned to one of the two arms of the study (OtoBand /
Sham Device A or OtoBand / Sham Device B). This is a blinded study in which every
participant will be evaluated, and each participant may select the stimulation that best
suits him or her on both of the study devices.

Each participant will select his/her preferred stimulation level by pressing the power
level button on the study device; however, they will be blinded to which device they are
using. Study participants will be asked to use the devices whenever they are having a
symptom of vertigo. Each participant will be asked to record his/her level of vertigo in
the online Study Diary: before putting on the device, after wearing the device for 5
minutes, after removing the device.

The study devices will record the following information regarding usage: Date and time
when the device is turned on/off and the power level, Date and time when the power level
is changed and the new power level.

Participants will be allowed to use the device as long as they are getting benefit from
the device at any power setting that they select. Participants will be asked to complete
an entry in the Study Diary even on days on which they do not experience a vertigo
episode.

The study coordinator will schedule six study monitoring call with each participant as
close as possible to the following schedule:

Call 1: Device I: 4 days after enrollment Call 2: Device I: 9 days after enrollment Call
3: Device I: 14 days after enrollment Call 4: Device II: 17 days after enrollment Call 5:
Device II: 22 days after enrollment Call 6: Device II: 27 days after enrollment

Otoband

Sham A

Sham B

The primary endpoint will be the change in vertigo severity rating while wearing the
OtoBand compared to the change vertigo severity while wearing the sham device during the
worst, most intense episode of vertigo within each treatment period (sham versus OtoBand
device).

Chief Science Officer

This secondary outcome measure will be a statistically significant average improvement in
reported vertigo when wearing the OtoBand, using the average change in reported vertigo
when wearing the sham device as a reference.

We will compare the number of "definite vertigo days" during the study period, comparing
the OtoBand period vs the sham period.

We will compare the mean change in reported vertigo during the first week vs the second
week of use, for the period of OtoBand use and the period of sham device use. This will
give an indication of whether any potential therapeutic effect of the devices remains
constant over the duration of the study.

We will classify complaints expressed during monitoring visits as "discomfort",
"worsening" and those related to "efficacy", and model interactions between time and
number of complaints, as a function of the testing group (OtoBand versus sham).

We will evaluate any relationship between preferred bone conduction stimulation level and
severity of vertigo episodes, by modelling interactions between time and (mean) bone
conduction stimulation level selected by the participant for each vertigo episode, as a
function of the testing group (OtoBand versus sham).

We will evaluate any change in vertigo episode duration, by modelling interactions
between time (day) and duration of device use per episode, as a function of the testing
group (OtoBand versus sham).

We will measure the mean preferred power level per reported condition (BPPV,
vestibulopathy, Meniere, Migraine associated vertigo) over all participants.

We will measure any potential effectiveness of the sham devices, by comparing the mean
change in vertigo score with the OtoBand and with the sham, for each of the two sham
devices.

Participants in Arm 1 will receive, in random order, an OtoBand or Sham Device A to use
for two weeks each. Sham Device A is an OtoBand in which the transducer is modified so
that the vibrations do not target the vestibular system. There will be a two-day washout
period between the devices. For the second two weeks, the participants will receive the
alternate device (i.e., sham or effective).

Participants in Arm 2 will receive, in random order, a OtoBand or Sham Device B. Sham
Device B is an OtoBand that operates at settings found to be non-therapeutic in motion
sickness studies. There will be a two-day washout period between the devices. For the
second two weeks, the participants will receive the alternate device (i.e., sham, or
effective).

Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status