Electrical Vestibular Stimulation (VeNS): Assessment of AMPK & SIRT1 Following Repeated Usage

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Device: Electrical vestibular nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants 35-60 years of age group Metabolic syndrome (BMI 25-35 kg/m2) Type 2 Diabetes Hyperlipidemia Willing participants Exclusion Criteria: Using Beta blockers Ear problems ( assessed during physical examination) Under any kind of therapy or treatment With severe complications Vestibular disorders

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A: Healthy control group<br>Neither placebo nor vestibular stimulation is administered | |
| Placebo Comparator: Group B: Placebo control group<br>Placebo stimulation along with regular treatment | Device: Electrical vestibular nerve stimulation<br>* Electrical vestibular nerve stimulation using a headset device<br>|
| Active Comparator: Group C: Intervention group<br>Electrical vestibular nerve stimulation along with regular treatment | Device: Electrical vestibular nerve stimulation<br>* Electrical vestibular nerve stimulation using a headset device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of SIRT1 (Sirtuin 1) | SIRT1 (Sirtuin 1) levels will be assessed from the blood samples by ELISA method using respective kits. | 4 weeks | 
| AMPK | AMPK levels will be assessed from the blood samples by ELISA method using respective kits. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pittsburgh Sleep Quality Index (PSQI) | 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 | 4 weeks | 
| The Epworth Sleepiness Scale (ESS) | 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) | 4 weeks |