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Completed

NCT Number: NCT05275790

Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial

The aim of this study is to observe the efficacy of electrical vestibular nerve stimulation in the management of obesity.

Allocation: Active device (participants act as their own self-control) Endpoint classification: Efficacy Study. The study provides further evidence for the efficacy of electrical vestibular nerve stimulation in the management of obesity.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RD Gardi Medical College

Ujjain, Madhya Pradesh, 456001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 30 to 40 kg/m2
  • Aged above 18 years

Exclusion criteria

  • Current use of any medications or therapy including use of oral contraceptives
  • Use of dietary supplements known to affect the BMI
  • Ear problems (assessed during physical examination)
  • Any severe complications
  • Unwilling participants

Treatment and study plan

Vestal device

Device

Battery powered non-invasive neurostimulation device

Lifestyle Intervention

Behavioral

All subjects will be prescribed a diet plan and instructed to follow it for the duration of the 12-week study. The diet plan will be designed by the P.I. who is a qualified, obesity management coach.

Primary outcomes

  1. Lipid profile

    Time frame: 12 weeks

    Blood sample to calculate ratio of Total Cholesterol: HDL and LDL

Secondary outcomes

  1. Liver function tests

    Time frame: 12 weeks

    Albumin test

  2. Complete blood count

    Time frame: 12 weeks

    Complete blood count

  3. Glycated hemoglobin

    Time frame: 12 weeks

    HbA1c as a percentage

  4. Mean blood glucose

    Time frame: 12 weeks

    Fasting glucose in mg/dL

Sponsors and collaborators

Lead sponsor

Neurovalens Ltd.

Industry

Collaborators

  • RD Gardi Medical College

Registry information

Official study title

Electrical Vestibular Nerve Stimulation (VeNS) Together With a Lifestyle Modification Program, Compared to a Sham Control With a Lifestyle Modification Program, as a Means of Reducing Excess Body Weight.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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