Efficacy of Electrical Vestibular Nerve Stimulation (VeNS... | NCT05275790

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

NCT05275790

Sponsor

Neurovalens Ltd.

Status

Completed

Last Update Posted

Nov 13, 2023Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Vestal device
Lifestyle intervention

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Oct 17, 2022Actual

Completion Date

Oct 17, 2022Actual

First Submitted Date

Feb 2, 2022

First Submission Date that Met QC Criteria

Mar 2, 2022

First Posted Date

Mar 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2023

Last Update Posted Date

Nov 13, 2023Actual

Name	Class
RD Gardi Medical College	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vestal active device	Experimental	10 subjects to receive an active device plus a diet plan for 12 weeks.	Device: Vestal device Behavioral: Lifestyle intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vestal device	Device	Battery powered non-invasive neurostimulation device	Vestal active device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lipid profile	Blood sample to calculate ratio of Total Cholesterol: HDL and LDL	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Liver function tests	Albumin test	12 weeks
Complete blood count	Complete blood count	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Sai Sailesh Kumar Goothy	RD Gardi Medical College, Ujjain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RD Gardi Medical College		Ujjain	Madhya Pradesh	456001	India

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided