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

NCT04869020 | Completed DMC FDA Device

• 1 other identifier: Olith10701
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vertigo

Keywords

BPPV; Meniere's disease; Migraine associated vertigo; Labyrinthitis; Vestibular neuritis

Outcome Measures

Primary Outcomes (1)

• Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.

  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).

  Forms filled out daily over four week period by the study participant

Secondary Outcomes (8)

• Average change in vertigo severity rating while wearing the OtoBand compared to average change in vertigo severity while wearing the sham device.

  Forms filled out daily over four week period by the study participant

• Frequency of vertigo events during each period of testing (OtoBand versus sham).

  Forms filled out daily over four week period by the study participant

• Durability of the effect over the observation period.

  Forms filled out daily over four week period by the study participant

• Complaints regarding usage.

  Information gathered in each monitoring visits over the four week period.

• Relationship of the bone conduction stimulation level (in dB) selected by the participant to severity of reported vertigo.

  Forms filled out daily by the study participant over four week period compared to two data files captured by the devices over their two week usage.

Study Arms (2)

Otoband efficacy versus Sham A

OTHER

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).

Device: Otoband; Device: Sham A

Otoband efficacy versus Sham B

OTHER

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).

Device: Otoband; Device: Sham B

Interventions

Otoband DEVICE

Participants with vertigo will wear the Otoband set at their chosen power level when experiencing symptoms.

Otoband efficacy versus Sham A; Otoband efficacy versus Sham B

Sham A DEVICE

Sham Device A is an OtoBand in which the transducer is modified so that the vibrations are not targeted at the vestibular system.

Otoband efficacy versus Sham A

Sham B DEVICE

Sham Device B is an OtoBand that operates at power settings found to be nontherapeutic against vertigo associated with virtual reality.

Otoband efficacy versus Sham B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otolith Labs: lead

Study Sites (1)

Otolith Labs

Washington D.C., District of Columbia, 20009, United States

Location

MeSH Terms

Conditions

Vertigo; Meniere Disease; Labyrinthitis; Vestibular Neuronitis

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endolymphatic Hydrops; Otitis; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Cranial Nerve Diseases

Study Officials

• Didier Depireux, PhD

  OtolithLabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant will be assigned to one of the study's two arms. Participants in Arm 1 will receive, in random order, an OtoBand or Sham Device A to use for two weeks each. Participants in Arm 2 will receive, in random order, a OtoBand or Sham Device B. The participants and researchers will be blinded to which arm of the study a participant is assigned and they will not know if the device in use is effective or placebo.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 3, 2021
• Study Start: April 19, 2021
• Primary Completion: December 27, 2021
• Study Completion: November 26, 2022
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)