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

NCT05960786 | Completed DMC FDA Device

• 1 other identifier: OLith10702
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Moderate or Worse Change in Vertigo Severity

  Change in participant response to "How severe is your vertigo right now?" during vertigo episodes, compared to responses in baseline phase

  Through 21 days of treatment phase of "moderate of worse" arm of study

• Quality of Life Change in Scores

  Change in participant's Vertigo Symptom Scale (VSS) score, compared to baseline VSS score

  Day 28 of treatment phase of "quality of life" arm of study

Secondary Outcomes (1)

• Device Effectiveness

  30 minutes post vertigo episode during the treatment phase

Other Outcomes (1)

• Effectiveness of Rating Scales

  Through 21 days of treatment phase of "moderate of worse" arm of study

Study Arms (4)

1. Moderate or Worse (MoW) Arm

EXPERIMENTAL

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device.

Device: Otoband Experimental

2. Moderate or Worse (MoW) Arm

SHAM COMPARATOR

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device.

Device: Otoband Sham

1. Quality of Life (QoL) Arm

EXPERIMENTAL

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device.

Device: Otoband Experimental

2. Quality of Life (QoL) Arm

SHAM COMPARATOR

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device.

Device: Otoband Sham

Interventions

Otoband Experimental DEVICE

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

1. Moderate or Worse (MoW) Arm; 1. Quality of Life (QoL) Arm

Otoband Sham DEVICE

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

2. Moderate or Worse (MoW) Arm; 2. Quality of Life (QoL) Arm

Eligibility Criteria

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

You may qualify if:

• To be eligible to participate in this study, an individual must meet all the following criteria:
• Diagnosed as having vestibular vertigo that is caused by one or more of:
• Benign paroxysmal positional vertigo (BPPV)
• Migraine associated vertigo (MAV, aka vertiginous migraines)
• Meniere's disease (aka idiopathic endolymphatic hydrops)
• Uncompensated unilateral vestibulopathy (such as arising from vestibular neuritis and labyrinthitis)
• Vertigo that has been present for at least 90 days
• Score greater than 35, and less than 91, on the Dizziness Handicap Inventory (corresponding to moderate to severe vertigo)
• Smartphone, computer or tablet and access to internet for online enrollment, check-in and wrap-up meetings
• Willingness to install and use the JotForm ePRO app
• Residing in the United States
• Willingness to be paid via Venmo or PayPal.

You may not qualify if:

• Surgery to the base of the skull within the last 6 months or plans for surgery to the skull during enrollment period
• Any skull or neck implants such as but not limited to a cochlear implant, vascular stents, bone conduction implant, or deep brain stimulation device
• History of vitreous detachment (aka floaters) in the last 90 days
• Superior canal dehiscence (aka third window) or otic capsule dehiscence
• Hyperacusis (aka hypersensitivity to loud sounds)
• Currently undergoing vestibular rehabilitation therapy or planning to start vestibular rehabilitation therapy during the study. (People who have completed vestibular rehabilitation therapy, but in whom vestibular vertigo persists, will be permitted to enroll)
• History of cerebrovascular disorders
• Posterior fossa tumors (brain tumors located in the caudal third of the skull)
• Vestibular schwannoma (non-cancerous tumor located on the vestibulo-cochlear nerve)
• Cerebellar degeneration (progressive worsening of neurons behind the brain stem)
• Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam) for vestibular issues.

Sponsors & Collaborators

• Otolith Labs: lead
• MCRA: collaborator

Study Sites (1)

Otolith Labs

Washington D.C., District of Columbia, 20001, United States

Location

MeSH Terms

Conditions

Vertigo; Meniere Disease; Vestibular Diseases; Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endolymphatic Hydrops

Study Officials

• Didier Depireux, PhD

  Otolith Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: July 27, 2023
• Study Start: February 2, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (1)