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

Primary Purpose

Vertigo, BPPV, Meniere Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Otoband Experimental
Otoband Sham
Sponsored by
Otolith Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Otolith LabsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

1. Moderate or Worse (MoW) Arm

2. Moderate or Worse (MoW) Arm

1. Quality of Life (QoL) Arm

2. Quality of Life (QoL) Arm

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Device Effectiveness
Percent change in mean severity of vertigo episodes as reported by the participant during the Treatment phase, compared to the Baseline phase.

Full Information

First Posted
May 18, 2023
Last Updated
July 21, 2023
Sponsor
Otolith Labs
Collaborators
MCRA
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1. Study Identification

Unique Protocol Identification Number
NCT05960786
Brief Title
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Official Title
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
September 7, 2023 (Anticipated)
Study Completion Date
October 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otolith Labs
Collaborators
MCRA

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, BPPV, Meniere Disease, Labrynthitis, Vestibular Disorder, Vestibular Migraine, Benign Paroxysmal Positional Vertigo, Ménière's Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Moderate or Worse (MoW) Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
2. Moderate or Worse (MoW) Arm
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
1. Quality of Life (QoL) Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
2. Quality of Life (QoL) Arm
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Otoband Experimental
Intervention Description
Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.
Intervention Type
Device
Intervention Name(s)
Otoband Sham
Intervention Description
Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.
Primary Outcome Measure Information:
Title
Moderate or Worse Change in Vertigo Severity
Description
Change in participant response to "How severe is your vertigo right now?" during vertigo episodes, compared to responses in baseline phase
Time Frame
Through 21 days of treatment phase of "moderate of worse" arm of study
Title
Quality of Life Change in Scores
Description
Change in participant's Vertigo Symptom Scale (VSS) score, compared to baseline VSS score
Time Frame
Day 28 of treatment phase of "quality of life" arm of study
Secondary Outcome Measure Information:
Title
Device Effectiveness
Description
Percent change in mean severity of vertigo episodes as reported by the participant during the Treatment phase, compared to the Baseline phase.
Time Frame
30 minutes post vertigo episode during the treatment phase
Other Pre-specified Outcome Measures:
Title
Effectiveness of Rating Scales
Description
Comparison of Verbal Rating Scale vs. Numerical Rating Scale as representation of participant response to device treatment.
Time Frame
Through 21 days of treatment phase of "moderate of worse" arm of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alesia Robinson
Phone
1 301-244-8846
Email
alesia@otolithlabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Depireux, PhD
Organizational Affiliation
Otolith Labs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Otolith Labs
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Daggitt
Email
Jack@otolithlabs.com

12. IPD Sharing Statement

Learn more about this trial

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

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