Trials / Completed
CompletedNCT04595968
Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 267 (actual)
- Sponsor
- Neurovalens Ltd. · Industry
- Sex
- All
- Age
- 22 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vestal DM Active device | Battery powered non-invasive neurostimulation device |
| BEHAVIORAL | Lifestyle modification | Subjects are prescribed a low calorie (500kcal deficit) diet if their BMI is ≥25. If a subject has a BMI of ≤24.9, they will be provided with guidance on ensuring their recommended daily dietary intake is achieved throughout the course of the trial (i.e 2,500kcal/day for men and 2,000kcal/day for women) |
| DEVICE | Vestal DM Sham device | Placebo comparator sham device (no active stimulation) |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2024-08-06
- Completion
- 2024-08-06
- First posted
- 2020-10-22
- Last updated
- 2024-09-19
Locations
16 sites across 2 countries: United States, Ireland
Source: ClinicalTrials.gov record NCT04595968. Inclusion in this directory is not an endorsement.