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Clinical Trials/NCT05275790
NCT05275790
Completed
N/A

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.

Neurovalens Ltd.1 site in 1 country10 target enrollmentApril 1, 2022
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ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Neurovalens Ltd.
Enrollment
10
Locations
1
Primary Endpoint
Lipid profile
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
October 17, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Neurovalens Ltd.
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Lipid profile

Time Frame: 12 weeks

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

Secondary Outcomes

  • Mean blood glucose(12 weeks)
  • Liver function tests(12 weeks)
  • Glycated hemoglobin(12 weeks)
  • Complete blood count(12 weeks)

Study Sites (1)

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