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

NCT ID: NCT04433273

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A: Healthy control group

Neither placebo nor vestibular stimulation is administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B: Placebo control group

Placebo stimulation along with regular treatment

Group Type: PLACEBO_COMPARATOR

Electrical vestibular nerve stimulation

Intervention Type: DEVICE

Electrical vestibular nerve stimulation using a headset device

Group C: Intervention group

Electrical vestibular nerve stimulation along with regular treatment

Group Type: ACTIVE_COMPARATOR

Electrical vestibular nerve stimulation

Intervention Type: DEVICE

Electrical vestibular nerve stimulation using a headset device

Interventions

Electrical vestibular nerve stimulation

Electrical vestibular nerve stimulation using a headset device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Compliance Solutions Ltd.

INDUSTRY

Sponsor Role: collaborator

RD Gardi Medical College

UNKNOWN

Sponsor Role: collaborator

Neurovalens Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RD Gardi Medical College

Ujjain, Madhya Pradesh, India

Countries

India

Other Identifiers

IVS002A

Identifier Type: -

Identifier Source: org_study_id