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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05960786
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Collaborator:
MCRA
Information provided by (Responsible Party):
Otolith Labs

Study Description
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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 vertigo.

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

  • Which device do participants respond better to (that is, find more relief)?
  • To what degree do participants find relief?

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.


Condition or disease Intervention/treatment Phase
Vertigo BPPV Meniere Disease Labrynthitis Vestibular Disorder Vestibular Migraine Benign Paroxysmal Positional Vertigo Ménière's Vertigo Device: Otoband Experimental Device: Otoband Sham Not Applicable

Detailed Description:

This study is decentralized clinical trial. This study uses technology and and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 36 participants in the MoW arm have completed the study, and until 72 participants have completed the QoL arm.

All study participants that meet all of the inclusion, none of the exclusion criteria, and sign informed consent will be enrolled in the study. Participants will complete a one day enrollment meeting and an approximately 14 day Baseline Phase.

After the Baseline Phase participants will be placed in one of two groups Moderate or Worse (MoW) group or Quality of Life (QoL) group based on the data collected about their vertigo during the Baseline Phase.

Participants will then be randomized within their assigned group (MoW or QoL) at a 2:1 ratio to an active arm or sham arm to begin the Treatment Phase of the study. Participants will be sent a study device to use when they have a vertigo episode.

Participants that enroll in the study are expected to participate up to 49 days with virtual meetings at the approximate intervals:

MoW Group: Day 21, Day 24, Day 31, and Day 42 QoL Group : Day 16, Day, 24, Day 36, and Day 49

Participants will be required to complete the DHI (Dizziness Handicap Index), VSS (Vertigo Symptom Scale), Global Impression of Symptoms, and Global Impression of Change questionnaires.

Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May, 2021

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Actual Study Start Date : February 2, 2023
Estimated Primary Completion Date : September 7, 2023
Estimated Study Completion Date : October 7, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1. Moderate or Worse (MoW) Arm
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
Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.
Sham Comparator: 2. Moderate or Worse (MoW) Arm
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
Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.
Experimental: 1. Quality of Life (QoL) Arm
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
Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.
Sham Comparator: 2. Quality of Life (QoL) Arm
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
Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.


Outcome Measures
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Primary Outcome Measures :
  1. Moderate or Worse Change in Vertigo Severity [ Time Frame: Through 21 days of treatment phase of "moderate of worse" arm of study ]
    Change in participant response to "How severe is your vertigo right now?" during vertigo episodes, compared to responses in baseline phase

  2. Quality of Life Change in Scores [ Time Frame: Day 28 of treatment phase of "quality of life" arm of study ]
    Change in participant's Vertigo Symptom Scale (VSS) score, compared to baseline VSS score


Secondary Outcome Measures :
  1. Device Effectiveness [ Time Frame: 30 minutes post vertigo episode during the treatment phase ]
    Percent change in mean severity of vertigo episodes as reported by the participant during the Treatment phase, compared to the Baseline phase.


Other Outcome Measures:
  1. Effectiveness of Rating Scales [ Time Frame: Through 21 days of treatment phase of "moderate of worse" arm of study ]
    Comparison of Verbal Rating Scale vs. Numerical Rating Scale as representation of participant response to device treatment.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05960786


Contacts
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Contact: Alesia Robinson 1 301-244-8846 alesia@otolithlabs.com

Locations
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United States, District of Columbia
Otolith Labs Recruiting
Washington, District of Columbia, United States, 20001
Contact: Jack Daggitt       Jack@otolithlabs.com   
Sponsors and Collaborators
Otolith Labs
MCRA
Investigators
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Principal Investigator: Didier Depireux, PhD Otolith Labs
More Information
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Responsible Party: Otolith Labs
ClinicalTrials.gov Identifier: NCT05960786    
Other Study ID Numbers: OLith10702
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Vertigo
Meniere Disease
Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Dizziness
Labyrinth Diseases
 Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders
Endolymphatic Hydrops