Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand

Summary

The goal of this virtual clinical trial is to determine the effectiveness of two study devices in providing temporary relief to adults aged 18-70 who suffer from symptoms of chronic vestibular vertigo.

The main question\[s\] it aims to answer are:

* Within an episode, is there a significant difference between the randomized study devices at the individual timepoints during the vertigo episode?
* Within an episode, is there evidence of quantitative treatment at each individual timepoint during the vertigo episode?

Participants will be:

* Enrolled up to 49 days; 14 days in Baseline Phase (no device) and 21 days in Treatment Phase (study device) for Study Arm 1 or 28 days in Treatment Phase (study device) for Study Arm 2
* Randomized and stratified into groups based on diagnosis to be assigned a study device
* Asked to use the study device as instructed by the study coordinator
* Asked to download a study app to submit daily diaries regarding their symptoms and use of device, and to participate in tele-health visits with study coordinators
* Asked to provide their vertigo diagnosis from their physician
* Compensated for their participation

Researchers will compare the randomized groups to see which groups respond better to which device.

Conditions

• Vertigo
• BPPV
• Meniere Disease
• Labrynthitis
• Vestibular Disorder
• Vestibular Migraine
• Benign Paroxysmal Positional Vertigo
• Ménière's Vertigo
• Migraine Associated Vertigo
• Uncompensated Unilateral Vestibulopathy

Interventions

DEVICE

Otoband Experimental

Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.

DEVICE

Otoband Sham

Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.

Sponsors & Collaborators

• MCRA

  collaborator INDUSTRY

• Otolith Labs

  lead INDUSTRY

Principal Investigators

• Didier Depireux, PhD · Otolith Labs

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-02

Primary Completion

2023-12-07

Completion

2023-12-07

FDA Device

Yes

Countries

• United States

Study Locations