<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433273</url>
  </required_header>
  <id_info>
    <org_study_id>IVS002A</org_study_id>
    <nct_id>NCT04433273</nct_id>
  </id_info>
  <brief_title>Electrical Vestibular Stimulation (VeNS): Assessment of AMPK &amp; SIRT1 Following Repeated Usage</brief_title>
  <official_title>A Randomized, Double-blind, Sham-controlled Trial to Evaluate Changes in AMPK Following Daily Vestibular Nerve Stimulation (VeNS) in Adults Who Are Overweight or Obese.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurovalens Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Compliance Solutions Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>RD Gardi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neurovalens Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The vestibular system which is responsible for balance and equilibrium constitutes our sixth&#xD;
      sense. Metabolic Syndrome is a constellation of metabolic abnormalities characterized by&#xD;
      obesity, insulin resistance (diabetes mellitus), hypertension, and dyslipidemia. It is&#xD;
      generally agreed that a combination of three or more of the following components must be&#xD;
      present: large waist circumference, elevated triglyceride, decreased high-density lipoprotein&#xD;
      (HDL) cholesterol raised blood pressure, and elevated fasting blood sugar (FBS). Sirtuin 1&#xD;
      (SIRT1) is one of seven mammalian orthologs of the yeast protein silent information&#xD;
      regulator. It is a conserved NAD-dependent protein deacetylase that decreases in cells that&#xD;
      have high insulin resistance. In vivo, insulin resistance and metabolic syndrome were&#xD;
      associated with low SIRT1 gene and protein expression. SIRT1 plays an important role to&#xD;
      stimulate AMPK in improving mitochondrial function both in-vitro and in-vivo. Adenosine&#xD;
      5'-monophosphate (AMP)-activated protein kinase (AMPK) is a key factor in regulating energy&#xD;
      metabolism, placing it at the center stage in studies of diabetes and related metabolic&#xD;
      disorders like metabolic syndrome. It was reported that over a period of 6 weeks regular&#xD;
      vestibular rehabilitation exercises caused an increase in the expression of SIRT1. The sleep&#xD;
      inducing effects of vestibular stimulation is well known. Earlier studies reported&#xD;
      improvement in the scores of Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness&#xD;
      Scale (ESS) followed by the vestibular stimulation. Hence, we hypothesize that vestibular&#xD;
      stimulation will lead to up-regulation of both SIRT1 and AMPK.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2022</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of SIRT1 (Sirtuin 1)</measure>
    <time_frame>4 weeks</time_frame>
    <description>SIRT1 (Sirtuin 1) levels will be assessed from the blood samples by ELISA method using respective kits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AMPK</measure>
    <time_frame>4 weeks</time_frame>
    <description>AMPK levels will be assessed from the blood samples by ELISA method using respective kits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a standard questionnaire used to assess sleep quality and quantity for the last month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.&#xD;
Minimum value = 0 Maximum value = 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Epworth Sleepiness Scale (ESS) is a standard questionnaire used as a subjective measure of a patient's sleepiness.&#xD;
Minimum value = 0 Maximum value = 24 A higher score indicates worse outcome (excessive sleepiness)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Group A: Healthy control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Neither placebo nor vestibular stimulation is administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Placebo control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo stimulation along with regular treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C: Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electrical vestibular nerve stimulation along with regular treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical vestibular nerve stimulation</intervention_name>
    <description>Electrical vestibular nerve stimulation using a headset device</description>
    <arm_group_label>Group B: Placebo control group</arm_group_label>
    <arm_group_label>Group C: Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male and female participants 35-60 years of age group Metabolic syndrome (BMI 25-35 kg/m2)&#xD;
        Type 2 Diabetes Hyperlipidemia Willing participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Using Beta blockers Ear problems ( assessed during physical examination) Under any kind of&#xD;
        therapy or treatment With severe complications Vestibular disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>RD Gardi Medical College</name>
      <address>
        <city>Ujjain</city>
        <state>Madhya Pradesh</state>
        <zip>456001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433273
org study id: IVS002A
nct id: NCT04433273
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The vestibular system which is responsible for balance and equilibrium constitutes our sixth
      sense. Metabolic Syndrome is a constellation of metabolic abnormalities characterized by
      obesity, insulin resistance (diabetes mellitus), hypertension, and dyslipidemia. It is
      generally agreed that a combination of three or more of the following components must be
      present: large waist circumference, elevated triglyceride, decreased high-density lipoprotein
      (HDL) cholesterol raised blood pressure, and elevated fasting blood sugar (FBS). Sirtuin 1
      (SIRT1) is one of seven mammalian orthologs of the yeast protein silent information
      regulator. It is a conserved NAD-dependent protein deacetylase that decreases in cells that
      have high insulin resistance. In vivo, insulin resistance and metabolic syndrome were
      associated with low SIRT1 gene and protein expression. SIRT1 plays an important role to
      stimulate AMPK in improving mitochondrial function both in-vitro and in-vivo. Adenosine
      5'-monophosphate (AMP)-activated protein kinase (AMPK) is a key factor in regulating energy
      metabolism, placing it at the center stage in studies of diabetes and related metabolic
      disorders like metabolic syndrome. It was reported that over a period of 6 weeks regular
      vestibular rehabilitation exercises caused an increase in the expression of SIRT1. The sleep
      inducing effects of vestibular stimulation is well known. Earlier studies reported
      improvement in the scores of Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness
      Scale (ESS) followed by the vestibular stimulation. Hence, we hypothesize that vestibular
      stimulation will lead to up-regulation of both SIRT1 and AMPK.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Assessment of SIRT1 (Sirtuin 1)
time frame: 4 weeks
description: SIRT1 (Sirtuin 1) levels will be assessed from the blood samples by ELISA method using respective kits.
measure: AMPK
time frame: 4 weeks
description: AMPK levels will be assessed from the blood samples by ELISA method using respective kits.
measure: The Pittsburgh Sleep Quality Index (PSQI)
time frame: 4 weeks
description: The Pittsburgh Sleep Quality Index (PSQI) is a standard questionnaire used to assess sleep quality and quantity for the last month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Minimum value = 0 Maximum value = 21
measure: The Epworth Sleepiness Scale (ESS)
time frame: 4 weeks
description: The Epworth Sleepiness Scale (ESS) is a standard questionnaire used as a subjective measure of a patient's sleepiness.
Minimum value = 0 Maximum value = 24 A higher score indicates worse outcome (excessive sleepiness)
arm group label: Group A: Healthy control group
arm group type: No Intervention
description: Neither placebo nor vestibular stimulation is administered
arm group label: Group B: Placebo control group
arm group type: Placebo Comparator
description: Placebo stimulation along with regular treatment
arm group label: Group C: Intervention group
arm group type: Active Comparator
description: Electrical vestibular nerve stimulation along with regular treatment
intervention type: Device
intervention name: Electrical vestibular nerve stimulation
description: Electrical vestibular nerve stimulation using a headset device
arm group label: Group B: Placebo control group
arm group label: Group C: Intervention group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No
ipd description: Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.