ObesityNCT05275790
Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial
A study testing Vestal device and Lifestyle intervention in people with Obesity, run by Neurovalens Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Vestal device and Lifestyle intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2022to 17 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 30 to 40 kg/m2
- Aged above 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Obesity
- Being tested
- Vestal device, Lifestyle intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestal deviceDevice
Battery powered non-invasive neurostimulation device
Lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Vestal active device | Experimental | 10 subjects to receive an active device plus a diet plan for 12 weeks. Receives: Device: Vestal device; Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Blood sample to calculate ratio of Total Cholesterol: HDL and LDL
Measured: 12 weeks
Secondary outcomes (4)
Liver function tests
Albumin test
Measured: 12 weeks
Complete blood count
Complete blood count
Measured: 12 weeks
Glycated hemoglobin
HbA1c as a percentage
Measured: 12 weeks
Mean blood glucose
Fasting glucose in mg/dL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Apr 2022
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RD Gardi Medical College
- Responsible party
- Sponsor
- Investigators
- Dr Sai Sailesh Kumar Goothy, Principal investigator, RD Gardi Medical College, Ujjain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275790
- Sponsor's protocol ID
- IVSWL001
- Status last verified
- Nov 2023
- First submitted
- 2 Feb 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05275790
- Acronym / sponsor ID
- IVSWL001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- RD Gardi Medical College
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vestal active device | Experimental | Device: Vestal device, Behavioral: Lifestyle intervention10 subjects to receive an active device plus a diet plan for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 30 to 40 kg/m2
- Aged above 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestal deviceBattery powered non-invasive neurostimulation device | Device | Vestal active device |
| Lifestyle interventionAll 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. | Behavioural | Vestal active device |
Primary outcome
Lipid profile
Time frame: 12 weeks
Blood sample to calculate ratio of Total Cholesterol: HDL and LDL
4 secondary outcomes
Liver function tests
Time frame: 12 weeks
Complete blood count
Time frame: 12 weeks
Glycated hemoglobin
Time frame: 12 weeks
Mean blood glucose
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Sai Sailesh Kumar Goothy principal investigator
RD Gardi Medical College, Ujjain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestal device and Lifestyle intervention in people with Obesity, run by Neurovalens Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.