Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial

Inclusion Criteria

• Signed informed consent
• Body mass index BMI ≥ 27 kg/m2.
• Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test at screen and also just before each DXA scan. (As DXA involves a small dose of ionizing radiation). They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain).
• 22-80 years of age inclusive on starting the study. (In order to comply with FDA guidance: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#s6)
• Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
• Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
• Agreement not to start smoking tobacco or marijuana

Exclusion Criteria

• History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
• History of bariatric surgery, or gastric resection.
• History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
• History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
• Use of a non-invasive weight loss device (e.g. Modius)
• Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
• Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
• Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
• Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
• Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
• Tobacco smoking (including vaping) in the six months prior to starting and for the duration of the study.
• Use of marijuana (smoking, vaping or in edible form) more than twice a month on average.
• Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
• Body weight change of more than 20% in either direction within the previous year.
• Physician-prescribed diet, and/ or current, active member of an organized weight loss program.
• Diabetes mellitus (Types 1 & 2).
• Diagnosis of epilepsy or use of anti-epileptic medication within six months of starting the study (e.g. for the treatment of peripheral neuropathy)
• Chronic (more than a month of daily use) treatment with opioid analgesic drugs within the last 6 months.
• Regular use (more than twice a month) of anti-histamine medication within the last 6 months.
• Use of oral or intravenous corticosteroid medication within 6 months of starting the study.
• Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study.
• Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
• An active diagnosis of cancer.
• A myocardial infarction within the preceding year.
• A history of stroke or severe head injury (as defined by a head injury that required craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
• Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
• Psychiatric disorders (including untreated severe depression, schizophrenia, substance abuse, eating disorder etc.)
• Current partici