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

This study is a decentralized clinical trial. This study uses technology and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 200 participants have completed the study per protocol. Study participants that meet all of the inclusion, none of the exclusion criteria, and sign the informed consent form will be enrolled in the study. Participants will complete a one day enrollment meeting and a 14 day Baseline Phase. If a participant is eligible to remain in the study for the Treatment Phase at day 15, they will be randomized within their assigned group at a 1:1 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 50 days with virtual meetings at the approximate intervals: Day 5, Day 15, Day 22, Day 25, Day 35, and Day 51 Participants will be required to complete the DHI (Dizziness Handicap Inventory), VM-PATHI (Vestibular Migraine Patient Assessment Tool and Handicap Inventory), General Vertigo History, Global Impression of Change, "Most Bothersome Symptom", Relief from "Most Bothersome Symptom", and Net promoter score questionnaires. Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021.