Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial
Not Applicable
Completed
- Conditions
- Obesity
- Interventions
- Device: Vestal deviceBehavioral: Lifestyle intervention
- 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
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
- Arm && Interventions
Group Intervention Description Vestal active device Vestal device 10 subjects to receive an active device plus a diet plan for 12 weeks. Vestal active device Lifestyle intervention 10 subjects to receive an active device plus a diet plan for 12 weeks.
- 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
Glycated hemoglobin 12 weeks HbA1c as a percentage
Complete blood count 12 weeks Complete blood count
Liver function tests 12 weeks Albumin test
Trial Locations
- Locations (1)
RD Gardi Medical College
🇮🇳Ujjain, Madhya Pradesh, India