Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Condition: Vertigo; BPPV; Meniere Disease; Labrynthitis; Vestibular Disorder; Vestibular Migraine; Benign Paroxysmal Positional Vertigo; Ménière's Vertigo
MeSH terms: Vertigo; Meniere Disease; Benign Paroxysmal Positional Vertigo; Vestibular Diseases; Dizziness
Study type: Interventional

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
    

Intervention name(s): Otoband Experimental; Otoband Sham
Intervention type(s): Device; Device
Intervention description(s): Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.; Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment