Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial
Condition: Obesity
Study type: Interventional

Summary: 
      A randomized, double blind sham controlled clinical trial to evaluate the efficacy of
      vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared
      to a sham control and a lifestyle modification program as a means of reducing excess body
      weight and body fat.

      The purpose of this investigation device study is to collect data to support regulatory
      submissions, primarily in the United States of America (USA), but it may also be used to
      support submissions in other regions, including the European Union (EU).
    

Detailed description: 
      In total there will be approximately 200 patients enrolled on the study around both sites. At
      the UCSD site there will be a total of about 106 total subjects (53 active treatment and 53
      control subjects) who are randomized into the treatment protocols having passed the screening
      criteria. At the UU site there will be a total of about 94 total subjects (47 active and 47
      control subjects).

      The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve
      stimulation (VeNS), together with a lifestyle modification program, as a method of reducing
      excess body weight and body fat, as compared to a sham control with both study arms
      incorporating a lifestyle modification program.

        -  Allocation: Randomized

        -  Endpoint classification: Efficacy Study

        -  Intervention Model: Parallel Assignment in 1:1 active to control allocation

        -  The aim of the study is to recruit a total (i.e. across both sites) of 200 participants
           that pass the screening process and are randomized into the treatment protocols. With a
           dropout allowance of 10% this should generate a minimum of 90 active treatment and 90
           control subjects. (In order to achieve adequate numbers, Neurovalens Ltd. estimate that
           the clinical site may have to consent (i.e. enroll into the study) up to 150 subjects at
           the UCSD site, in order to achieve adequate numbers, it is estimated that the clinical
           site may have to consent (i.e. enroll into the study) up to 150 subjects at the UU site,
           as the baseline screening can only take place after the formal consent process as the
           baseline screening can only take place after the formal consent process.) The
           designation of treatment across the two study sites will be as follows:

             -  USCD: a total of about 106 subjects who pass through screening and are randomized
                (53 active treatment and 53 control subjects);

             -  University of Ulster: a total of about 94 total subjects who pass through screening
                and are randomized (47 active and 47 control subjects).

        -  Masking: Double Blind (Subject, Nursing staff, Dietician, Co-coordinators, Outcomes
           Assessor and any other study staff who have contact with the subject)

        -  Data from both sites will be collated at the end of the studies and analysis will be
           performed on one data set.

      Study staff will train the subject on how to use their study device. Specifically this will
      include: how to first prepare the skin over the mastoid processes with an alcohol wipe; a
      demonstration of where to place the hydrogel electrodes; how to access the VeSTAL study app
      and pair the iPod (using Bluetooth) to the device; how to operate the device using the app;
      and how to use the up/down buttons on the device if unable to use the study app. Study staff
      will provide subjects with a printed copy of the IFU and also highlight its location as a PDF
      on the iPod. The Device Use Schematic will also be highlighted to the subjects - it will only
      be as a PDF on the iPod.

      Also study staff will demonstrate to the subjects: how to charge the device; to dispose of
      used electrodes after a stimulation session; how to store unused electrodes in a sealed
      manner so they do not dry out; how to turn the device on and off using the power button; and
      how to use the app or power button to pause a stimulation session.

      Subjects will be asked to try and use their allocated device for an hour every day, and at
      least five times a week. Theoretically it is thought that the device may be more effective if
      used while sitting upright (as opposed to lying flat), due to the orientation of the otolith
      organs. As such subjects will be encouraged to use the device while sitting upright, and also
      in the evening as sometimes people can feel a bit soporific after vestibular stimulation.
      Subjects will be instructed not to walk around, operate machinery or drive while using their
      device.
    

Intervention name(s): VeSTAL
Intervention type(s): Device
Intervention description(s): The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overweight; Metabolic syndrome; Weight loss; Diet; Atherogenic index; Prediabetes