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

Otolith Labs

Status: Completed

Conditions: Vertigo

Treatments: Device: Otoband; Device: Sham B; Device: Sham A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04869020

Olith10701

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects age 18 to 70 years old
• Vertigo that has been present for at least 90 days
• Vertigo that is constant or predictable
• Consulted a medical doctor in the past 24 months regarding their vertigo
• Identify as having vertigo from one of the following causes:
• Benign Paroxysmal Positional Vertigo (BPPV)
• Meniere's Disease
• Vestibular Migraines
• Migraine Associated Vertigo
• Vestibular Neuritis
• Labyrinthitis
• Vertigo caused by COVID-19
• Score within appropriate range on the Dizziness Handicap Inventory
• Have a computer and access to internet for online video conferences
• PayPal, Venmo or Zelle account to receive compensation

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)
• Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam) for dizziness
• Vitreous detachment of the retina (floaters in the eye) in the previous 90 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Otoband efficacy versus Sham A

Other group

Description:

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).

Treatment:

Device: Sham A

Device: Otoband

Otoband efficacy versus Sham B

Other group

Description:

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).

Treatment:

Device: Sham B

Device: Otoband