Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT04595968. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 Program, As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Trial Title 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 program, as a means of improving glycemic control in adults with type 2 diabetes mellitus. The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing HbA1c, as compared to a sham control. Allocation: Randomized to either active device or control device usage. All subjects will receive the same lifestyle advice. Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Trial Participants: Those who have been diagnosed with Type 2 diabetes mellitus. Planned Trial Period: The study will last 24 weeks in total for each subject. The primary analysis will be conducted at the 24 weeks timepoint.
Study identification
- NCT ID
- NCT04595968
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 267 participants
Conditions and interventions
Conditions
Interventions
- Vestal DM Active device Device
- Lifestyle modification Behavioral
- Vestal DM Sham device Device
Device · Behavioral
Eligibility (public fields only)
- Age range
- 22 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 20, 2021
- Primary completion
- Aug 5, 2024
- Completion
- Aug 5, 2024
- Last update posted
- Sep 18, 2024
2021 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| UC San Diego, Exercise and Physical Activity Resource Center | La Jolla | California | 92093 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| New Med Research | Hollywood | Florida | 33020 | — |
| South Florida Research Organization | Medley | Florida | 33166 | — |
| Adult Medicine of Lake County | Mt. Dora | Florida | 32757 | — |
| Oviedo Medical Research | Oviedo | Florida | 32765 | — |
| ActivMed Practices & Research | Methuen | Massachusetts | 01844 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| Palm Research Center | Las Vegas | Nevada | 89148 | — |
| ActivMed Practices & Research | Portsmouth | New Hampshire | 03801 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Complete Health Partners | Nashville | Tennessee | 37209 | — |
| Biopharma Informatic | McAllen | Texas | 78503 | — |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04595968, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2024 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04595968 live on ClinicalTrials.gov.