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

Otolith Labs · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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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.
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