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Effect of VeSTAL Device in Type 2 Diabetes Mellitus

NCT04149951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-16

No results posted yet for this study

Summary

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 with both study arms incorporating a lifestyle modification program.

* Allocation: Randomized
* Endpoint classification: Efficacy Study
* Intervention Model: Parallel Assignment in 1:1 active to control allocation

Conditions

Interventions

DEVICE

Vestal Device

Vestibular nerve stimulator

DEVICE

Placebo device

Sham nerve stimulator

Sponsors & Collaborators

  • Compliance Solutions Ltd.

    collaborator INDUSTRY

  • University College Dublin

    collaborator OTHER

  • Exploristics Ltd

    collaborator UNKNOWN

  • Neurovalens Ltd.

    lead INDUSTRY

Principal Investigators

  • Carel Le Roux, MD PhD · UCD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2021-01-22
Completion
2021-01-22

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149951 on ClinicalTrials.gov