NCT05275790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

February 2, 2022

Last Update Submit

November 10, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Lipid profile

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

    12 weeks

Secondary Outcomes (4)

  • Liver function tests

    12 weeks

  • Complete blood count

    12 weeks

  • Glycated hemoglobin

    12 weeks

  • Mean blood glucose

    12 weeks

Study Arms (1)

Vestal active device

EXPERIMENTAL

10 subjects to receive an active device plus a diet plan for 12 weeks.

Device: Vestal deviceBehavioral: Lifestyle intervention

Interventions

Vestal deviceDEVICE

Battery powered non-invasive neurostimulation device

Vestal active device
Lifestyle interventionBEHAVIORAL

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.

Vestal active device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RD Gardi Medical College

Ujjain, Madhya Pradesh, 456001, India

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Sai Sailesh Kumar Goothy

    RD Gardi Medical College, Ujjain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Bilateral electrical vestibular nerve stimulation will be administered using a battery-powered vestibular nerve stimulator (ML 1000). Participants will act as their own self-control.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2022

First Posted

March 11, 2022

Study Start

April 1, 2022

Primary Completion

October 17, 2022

Study Completion

October 17, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

IN(1)