Clinical trial NCT04869020: Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
Official title: Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vertigo
Keywords: BPPV
Meniere's disease
Migraine associated vertigo
Labyrinthitis
Vestibular neuritis
Lead sponsor: Otolith Labs
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: In this phase of this pilot study, a minimum of 20 participants will be enrolled, with up to 100 participants maximum. This will provide adequately powered pilot data to measure effect size for the OtoBand and sham devices and to identify different causes of vertigo for which the OtoBand has a particularly strong effect as measured by the Otolith Vertigo Assessment Tool. After inclusion/exclusion screening and informed consent is obtained, potential participants will be assessed using the Dizziness Handicap Inventory (DHI). The DHI will be completed online.

Potential participants with a DHI score in the appropriate range will be accepted into the study. These participants will be asked to schedule an online meeting to with the study coordinator. In this online enrollment meeting, the study coordinator will review the Informed Consent and confirm other information supplied by the participant online (inclusion/exclusion) and then make an affirmative decision to enroll or not enroll participants in the study.

The participants will be randomly assigned to one of the two arms of the study (OtoBand / Sham Device A or OtoBand / Sham Device B). This is a blinded study in which every participant will be evaluated, and each participant may select the stimulation that best suits him or her on both of the study devices.

Each participant will select his/her preferred stimulation level by pressing the power level button on the study device; however, they will be blinded to which device they are using. Study participants will be asked to use the devices whenever they are having a symptom of vertigo. Each participant will be asked to record his/her level of vertigo in the online Study Diary: before putting on the device, after wearing the device for 5 minutes, after removing the device.

The study devices will record the following information regarding usage: Date and time when the device is turned on/off and the power level, Date and time when the power level is changed and the new power level.

Participants will be allowed to use the device as long as they are getting benefit from the device at any power setting that they select. Participants will be asked to complete an entry in the Study Diary even on days on which they do not experience a vertigo episode.

The study coordinator will schedule six study monitoring call with each participant as close as possible to the following schedule:

Call 1: Device I: 4 days after enrollment Call 2: Device I: 9 days after enrollment Call 3: Device I: 14 days after enrollment Call 4: Device II: 17 days after enrollment Call 5: Device II: 22 days after enrollment Call 6: Device II: 27 days after enrollment

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.
timeFrame: Forms filled out daily over four week period by the study participant
Secondary outcomes:
measure: Average change in vertigo severity rating while wearing the OtoBand compared to average change in vertigo severity while wearing the sham device.
timeFrame: Forms filled out daily over four week period by the study participant
measure: Frequency of vertigo events during each period of testing (OtoBand versus sham).
timeFrame: Forms filled out daily over four week period by the study participant
measure: Durability of the effect over the observation period.
timeFrame: Forms filled out daily over four week period by the study participant
measure: Complaints regarding usage.
timeFrame: Information gathered in each monitoring visits over the four week period.
measure: Relationship of the bone conduction stimulation level (in dB) selected by the participant to severity of reported vertigo.
timeFrame: 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.
measure: Duration of use within each episode of vertigo and over the entire observation period.
timeFrame: Forms filled out daily over four week period by the study participant
measure: Identification of a preferred dose.
timeFrame: Data captured by the devices over the 14 days with each device.
measure: Identification of the sham device with the smallest placebo effect.
timeFrame: Forms filled out daily over 2 week period by the study participant with the sham in each arm.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Otolith Labs
state: District of Columbia
Study officials:
affiliation: OtolithLabs
name: Didier Depireux, PhD
role: PRINCIPAL_INVESTIGATOR
References: