CompletedNot Applicable

SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines

United States322 participantsStarted 2024-03-06

Plain-language summary

The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo. Participants will be: * Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device) * Randomized and stratified into groups based on the referring clinic to be assigned one study device * Asked to use the study device as instructed by the study coordinator * Asked to submit daily diaries reporting 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 determine which group responds better to which device.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: To be eligible to participate in this study, an individual must meet all the following criteria: \- Diagnosed as having Vestibular Migraine (VM) (aka Migraine Associated Vertigo) The participant's diagnosis must be provided by a physician, Board certified in Otolaryngology or Neurology, from one of the study's approved clinics. Diagnosis for VM must follow Bárány Society's "International Classification of Vestibular Disorders", which contains the Society's consensus diagnostic criteria for VM \[Lempert 2022, sect. 3\]. * Male or female subjects, age 18 to 75 years old inclusive on day of enrollment * Residing in the United States * Vestibular migraines that have been recurrent for at least 90 days * Score from 36 to 90 inclusive on the Dizziness Handicap Inventory (DHI) (corresponding to moderate to severe vertigo) * A smartphone, computer or tablet and access to internet to complete study procedures and study meetings * Willing and able to comply with study procedures * Willingness to use Venmo or Paypal for study stipend Exclusion Criteria: * Females who are pregnant or trying to become pregnant * Enrolled in previous Otolith Lab-sponsored clinical trial * Currently taking part in another interventional trial * Surgery to the skull base within the last 6 months or plans for surgery to the skull during enrollment period * Skull or neck implants * History of vitreous detachment in the last 90 days * Superior canal dehiscence or otic capsule dehiscenc…

What they're measuring

DHI Change in Scores

Timeframe: Day 23 - Day 51

Trial details

NCT IDNCT06267924

SponsorOtolith Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-09