Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness
Condition: Dizziness; Vertigo; Vestibular Migraine; Vestibular Neuritis; Labyrinthitis
MeSH terms: Vertigo; Vestibular Neuronitis; Labyrinthitis; Neuritis; Dizziness
Study type: Interventional

Summary: 
      Vestibular disorders are among the most common causes of disability in society and affect
      over 50% of the population over the age of 65 and a significant percentage of the younger
      population. Vestibular disorders have a dramatic impact on daily life impacting work,
      relationships, and even activities of daily living.The OtoBand has shown promise and might be
      beneficial for treating or improving the course of recovery from vestibular disorders.

      This study seeks to quantify the effect of the study device, the OtoBand, on objective
      measures of dizziness and vertigo in patients with vestibular dysfunction.

      The study will be conducted at a single-site and will be a blinded, randomized,
      placebo-controlled design in which participants do not know if they are receiving bone
      conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
    

Detailed description: 
      Vestibular disorders are among the most common causes of disability in society and affect
      over 50% of the population over the age of 65 and a significant percentage of the younger
      population. Vestibular disorders have a dramatic impact on daily life impacting work,
      relationships, and even activities of daily living. At the current time, the mainstay of
      therapy for many vestibular disorders is a physical therapy called vestibular rehabilitation.
      While usually highly effective, this therapy is time consuming and not universally effective,
      in part because of inconsistent subject compliance. The use of adjuvant devices to speed
      recovery has been studied but very few devices have proved beneficial; the few that have
      shown benefit only work in special populations and are large units that cost several million
      dollars.

      In this study, the investigators will assay the efficacy of the OtoBand in participants with
      vertigo and dizziness. The OtoBand will be given to participants with vertigo and dizziness
      in patients with vestibular dysfunction. Participants will be recruited from patients who
      present at the Dizziness and Vertigo Institute of Los Angeles and for whom the Principal
      Investigators recommend a course of vestibular rehabilitation therapy. The OtoBand will be
      set at either a normal power (effective) or low power (lower than the power level thought to
      be effective, placebo device). Participants will not know if they are receiving receiving
      bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.

      This study seeks to determine if, in patients going to the Dizzy and Vertigo Institute of Los
      Angeles for vestibular rehabilitation therapy, objective measures of dizziness and vertigo
      are significantly changed by wearing the OtoBand.

      Potential changes will be measured in the following tests:

        -  Subjective Visual Vertical (SVV),

        -  Sinusoidal Harmonic Acceleration (SHA), also known as rotary chair test

        -  Spontaneous Nystagmus

      In this current protocol, three conditions (sham, therapeutic and no device) will be tested
      within an hour in a randomized sequence, with the OtoBand remaining in place throughout
      (turned off in the "no device" condition).

      The primary endpoint of the study is to determine the change(s) induced by the OtoBand in
      objective measures of vestibular symptoms.

      The secondary endpoints of the study include:

        -  Participant's questionnaire as to which level the participant believes they used first
           and second (sham setting vs therapeutic setting);

        -  Measure whether Migraine and Vestibulopathy patients experience higher benefits from a
           given power level as measured by objective tests (SVV, SHAs and spontaneous nystagmus);

        -  Measure whether Migraine and Vestibulopathy patients experience any benefit from the
           placebo setting.
    

Intervention name(s): Otoband; Placebo Device
Intervention type(s): Device; Device
Intervention description(s): Participants with Dizziness and Vertigo will wear the Otoband set at normal power (effective) during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.; Participants with Dizziness and Vertigo will wear the placebo device set at low power during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vestibular weakness