OverweightNCT04110717
Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight
A study testing Vestal Device and Hypocaloric Diet in people with Overweight and Obesity, run by Neurovalens Ltd. at 1 site in Ireland.
Trial summary
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification programme, as a means of reducing excess body weight and body fat. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Overweight and Obesity
- What is being tested?
- Vestal Device and Hypocaloric Diet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 9 Oct 2020to 23 Mar 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Body mass index (BMI) ≥ 25 kg/m2 2. Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain).
- 3. 18-80 years of age inclusive on starting the study. 4. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
- 5. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
- 6. Agreement not to start smoking tobacco or marijuana for the duration of the study.
- 7. Access to Wi-Fi (to connect iPod to internet)
Who cannot join
- 1. History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
- 2. History of bariatric surgery, or gastric resection. 3. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- 4. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti). 5. Use of a non-invasive weight loss device (e.g. Modius) 6. Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
- 7. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly) 8. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
- 9. Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
- 10. Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
Show all 18Show fewer
- 11. Tobacco or marijuana smoking in the 6 months before starting and for the duration of the study.
- 12. Known genetic cause of obesity (e.g., Prader-Willi Syndrome). 13. Body weight change of more than 20% in either direction within the previous year.
- 14. Physician-prescribed diet, and/ or current, active member of an organized weight loss program.
- 15. Diabetes mellitus (Types 1 \& 2). 16. Diagnosis of epilepsy or use of anti-epileptic medication within six months of starting the study (e.g. for the treatment of peripheral neuropathy) 17. Chronic (more than a month of daily use) treatment with opioid analgesic drugs within the last 6 months.
- 18. Regular use (more than twice a month) of anti-histamine medication within the last 6 months.
- 19. Use of oral or intravenous corticosteroid medication within 6 months of starting the study.
- 20. Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study.
- 21. Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
- 22. An active diagnosis of cancer. 23. A myocardial infarction within the preceding year. 24. A history of stroke or severe head injury (as defined by a head injury that required craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
- 25. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
- 26. Psychiatric disorders (including untreated severe depression, schizophrenia, substance abuse, eating disorder etc.) 27. Current participant in another weight loss study or other clinical trial. 28. Have a family member who is currently participating or is planning to participate in this study.
- 29. Pregnancy 30. History of migraine headaches
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 and Body Fat.
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification programme, as a means of reducing excess body weight and body fat.
- Being tested
- Vestal Device, Control Device, Hypocaloric Diet
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestal DeviceDevice
Vestibular nerve stimulator
Control DeviceDevice
Control Device
Hypocaloric DietBehavioural
Hypocaloric diet
| Study group | Role | What they receive |
|---|---|---|
| Active Device Group | Experimental | 25 subjects randomised to receive active device use plus lifestyle intervention for 3 months. Receives: Device: Vestal Device; Behavioral: Hypocaloric Diet |
| Control Device Group | Placebo comparator | 25 subjects randomised to receive control device use plus lifestyle intervention for 3 months. Receives: Device: Control Device; Behavioral: Hypocaloric Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body weight loss
In kg
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 posted1 Oct 2019
- Study start9 Oct 2020
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College Dublin, Exploristics Ltd, Compliance Solutions Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110717
- Sponsor's protocol ID
- 050719-UCD
- Status last verified
- Mar 2023
- First submitted
- 29 Sep 2019
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 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 and Body Fat.
- ClinicalTrials.gov ID
- NCT04110717
- Acronym / sponsor ID
- 050719-UCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University College Dublin, Exploristics Ltd, Compliance Solutions Ltd.
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 1 Oct 2019 (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.
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification programme, as a means of reducing excess body weight and body fat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Device Group | Experimental | Device: Vestal Device, Behavioral: Hypocaloric Diet25 subjects randomised to receive active device use plus lifestyle intervention for 3 months. |
| Control Device Group | Placebo comparator | Device: Control Device, Behavioral: Hypocaloric Diet25 subjects randomised to receive control device use plus lifestyle intervention for 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Body mass index (BMI) ≥ 25 kg/m2 2. Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain).
- 3. 18-80 years of age inclusive on starting the study. 4. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
- 5. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
- 6. Agreement not to start smoking tobacco or marijuana for the duration of the study.
- 7. Access to Wi-Fi (to connect iPod to internet)
Key exclusion criteria (18 listed)
- 1. History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
- 2. History of bariatric surgery, or gastric resection. 3. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- 4. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti). 5. Use of a non-invasive weight loss device (e.g. Modius) 6. Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
- 7. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly) 8. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
- 9. Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
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 DeviceVestibular nerve stimulator | Device | Active Device Group |
| Control DeviceControl Device | Device | Control Device Group |
| Hypocaloric DietHypocaloric diet | Behavioural | Active Device Group, Control Device Group |
Primary outcome
Total body weight loss
Time frame: 12 weeks
In kg
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 3 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypocaloric Diet in people with Overweight and Obesity, run by Neurovalens Ltd. at 1 site in Ireland.
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 5 inclusion and 18 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 3 Apr 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Total body weight loss (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 3 Apr 2023.