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

NCT04433273 | Not Yet Recruiting

• 1 other identifier: IVS002A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The Pittsburgh Sleep Quality Index (PSQI)

  4 weeks

• The Epworth Sleepiness Scale (ESS)

  4 weeks

Study Arms (3)

Group A: Healthy control group

NO INTERVENTION

Neither placebo nor vestibular stimulation is administered

Group B: Placebo control group

PLACEBO COMPARATOR

Placebo stimulation along with regular treatment

Device: Electrical vestibular nerve stimulation

Group C: Intervention group

ACTIVE COMPARATOR

Electrical vestibular nerve stimulation along with regular treatment

Device: Electrical vestibular nerve stimulation

Interventions

Electrical vestibular nerve stimulation DEVICE

Electrical vestibular nerve stimulation using a headset device

Group B: Placebo control group; Group C: Intervention group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants 35-60 years of age group Metabolic syndrome (BMI 25-35 kg/m2) Type 2 Diabetes Hyperlipidemia Willing participants

You may not qualify if:

• Using Beta blockers Ear problems ( assessed during physical examination) Under any kind of therapy or treatment With severe complications Vestibular disorders

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• Compliance Solutions Ltd.: collaborator
• RD Gardi Medical College: collaborator

Study Sites (1)

RD Gardi Medical College

Ujjain, Madhya Pradesh, 456001, India

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: May 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)