Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus

Completed · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID: NCT04595968
Run by: Neurovalens Ltd.
People needed: 267
Starts: 2021-05-21
Expected to finish: 2024-08-06
Last updated by the study team: 2024-09-19

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
Male or female, age ≥ 22 years and ≤ 70 years at the time of signing informed consent. (At the US sites). The non-US sites will recruit subjects aged ≥ 18 and ≤ 70 years.
Diagnosed with Type 2 DM ≥ 90 days prior to day of enrolment
HbA1c (glycated hemoglobin) ≥ 6.5 and ≤ 9.5% (48-80 mmol/mol) (both inclusive).
If taking medication to treat diabetes, a stable dose of no more than 3 anti-diabetic medications for at least 90 days prior to enrolment.
BMI ≥ 25 at non-US sites
Must be under care of physician for follow-up of their type 2 DM (this can be a Primary Care Physician (PCP), endocrinologist or other hospitalist).
Must agree to continue to participate with their routine diabetes care program.
Access to Wi-Fi.

You may not qualify if…

Diagnosis of Type 1 diabetes mellitus
Diagnosis of diabetic neuropathy
Diagnosis of diabetic nephropathy
Diagnosis of retinopathy
Skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears. Any disorder which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol.
Taking beta-blockers (if previously then can enroll if off ≥ 30 days).
Taking insulin (if previously on insulin then should be off for ≥ 90 days prior to enrolment).
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
History of pancreatitis
History of pancreatic surgery
Hemochromatosis
Either of the following within the previous year: myocardial infarction; or acute coronary syndrome.
History of stroke
History of epilepsy
Splenectomy (due to effect on red blood cell turnover)
History of anemia (if resolved for > 90 days with treatment then can enroll)
Blood transfusion within 90 days of enrolment (due to effect on HbA1c). (If transfusion occurs once enrolled then subject will be withdrawn).
A diagnosis of a hemoglobinopathy (e.g. sickle cell disease and thalassemia, although those with sickle cell or thalassemic trait would be allowed to enroll);
If on dietary supplements or herbal remedies, then if the subject is taking a preparation that might affect glycemic control they will be excluded. Specifically, subject will be excluded if taking biotin (vitamin B7); alpha-lipoic acid; chromium; herbal preparations marketed as being for diabetes.
History of being diagnosed with renal, heart or liver failure
History of active migraines with aura
History of head injury requiring intensive care or neurosurgery.
Change in diabetic medication within the last 90 days (prior to enrolment).
Regular use (more than twice a month) of antihistamine medication within the last 6 months. Note: If the participant is taking Fexofenadine, they can be eligible for the trial. If the participant is on another anti-histamine medication they can voluntarily opt to switch to Fexofenadine and enrol in the trial after a washout period of 2 weeks.
Current use of H2-receptior antagonist medication? (e.g., cimetidine, famotidine)

Where it is running

University of Alabama — Birmingham, Alabama, United States
UC San Diego, Exercise and Physical Activity Resource Center — La Jolla, California, United States
Northern California Research — Sacramento, California, United States
New Med Research — Hollywood, Florida, United States
South Florida Research Organization — Medley, Florida, United States
Adult Medicine of Lake County — Mt. Dora, Florida, United States
Oviedo Medical Research — Oviedo, Florida, United States
ActivMed Practices & Research — Methuen, Massachusetts, United States
Billings Clinic — Billings, Montana, United States
Palm Research Center — Las Vegas, Nevada, United States
ActivMed Practices & Research — Portsmouth, New Hampshire, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Complete Health Partners — Nashville, Tennessee, United States
Biopharma Informatic — McAllen, Texas, United States
Charlottesville Medical Research Center — Charlottesville, Virginia, United States
St. Vincent's University Hospital — Dublin, Dublin, Ireland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.