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

NCT04433273 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-21

No results posted yet for this study

Summary

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.

Conditions

  • Overweight and Obesity

Interventions

DEVICE

Electrical vestibular nerve stimulation

Electrical vestibular nerve stimulation using a headset device

Sponsors & Collaborators

  • Compliance Solutions Ltd.

    collaborator INDUSTRY

  • RD Gardi Medical College

    collaborator UNKNOWN

  • Neurovalens Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433273 on ClinicalTrials.gov