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

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT05275790
• Lead Sponsor: Neurovalens Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-04-01
• Primary Completion: 2022-10-17
• Study Completion: 2022-10-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Lipid profile	12 weeks	Blood sample to calculate ratio of Total Cholesterol: HDL and LDL

Secondary Outcome Measures

Name	Time	Method
Mean blood glucose	12 weeks	Fasting glucose in mg/dL
Liver function tests	12 weeks	Albumin test
Glycated hemoglobin	12 weeks	HbA1c as a percentage
Complete blood count	12 weeks	Complete blood count

Trial Locations

Locations (1)

RD Gardi Medical College; 🇮🇳 Ujjain, Madhya Pradesh, India