CTRI/2019/06/019854
Completed
Phase 1
Electrical Vestibular Nerve Stimulation for the Management of Diabetes
eurovalance lab0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Sponsor
- eurovalance lab
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes mellitus or impaired glucose tolerance (also termed pre\-diabetes)
- •18\-80 years of age inclusive on starting the study.
- •Ability and willingness to complete all study visits and procedures.
- •Owner of a smart phone (iOS or Android) in order to access the diet monitoring and advice app (GB Healthwatch 360\), activity monitoring app called Moves, and the app that reports on the status of the stimulation devices used in the study.
- •Agreement not to use of prescription drug therapy or the use of over\-the\-counter weight loss preparations for the duration of the trial.
- •Agreement not to start smoking tobacco or marijuana for the duration of the study.
- •Access to Wi\-Fi connection at home or at workplace â?? so device can upload usage data.
- •Stable diabetic regime for the last 3 months â?? i.e. no change in diabetic medication.
Exclusion Criteria
- •History of vestibular dysfunction.
- •History of pancreatic surgery.
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck.
- •History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
- •Untreated thyroid disorder (stable treatment for 3 months is acceptable).
- •Other untreated endocrinological disorder that may cause hyperglycemia (e.g. Cushingâ??s disease, Cushingâ??s syndrome or acromegaly) (Stable for 6 months is acceptable)
- •Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy, which would prevent VeNS from working).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical TrialObesityNCT05275790Neurovalens Ltd.10
Completed
Not Applicable
Effect of VeSTAL Device in Type 2 Diabetes MellitusType 2 DiabetesMetabolic SyndromeNCT04149951Neurovalens Ltd.50
Recruiting
Phase 1
Effects on postural control using Galvanic vestibular stimulation in spinal cord injury patientsSpinal Cord DiseasesRBR-8w55n2gniversidade Metodista de São Paulo - UMESP
Not yet recruiting
Phase 1
GVS and bedrestDeconditioning due to microgavityorthostatic hypotensionJPRN-jRCT1040230060Tanaka Kunihiko12
Completed
Not Applicable
Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body WeightOverweightObesityOverweight and ObesityOverweight or ObesityMetabolic SyndromeNCT04110717Neurovalens Ltd.50