| Eligibility |
Inclusion Criteria:
- 1. Body mass index (BMI) = 25 kg/m2 2. Males or Females. Note females of child-bearing
potential must have a negative urine pregnancy test 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).
3. 18-80 years of age inclusive on starting the study. 4. 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.
5. Agreement not to use of prescription, or over-the-counter, weight loss preparations
for the duration of the trial.
6. Agreement not to start smoking tobacco or marijuana for the duration of the study.
7. Access to Wi-Fi (to connect iPod to internet)
Exclusion Criteria:
- 1. History of vestibular dysfunction or other inner ear disease as indicated by the
screening questions.
2. History of bariatric surgery, or gastric resection. 3. History of skin breakdown,
eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind
the ears.
4. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti). 5. Use
of a non-invasive weight loss device (e.g. Modius) 6. 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).
7. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's
syndrome or acromegaly) 8. Previous diagnosis of HIV infection or AIDS (HIV is known
to cause a vestibular neuropathy which would prevent VeNS from working).
9. Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
10. Treatment with prescription weight-loss drug therapy in the 6 months before
starting the study.
11. Tobacco or marijuana smoking in the 6 months before starting and for the duration
of the study.
12. Known genetic cause of obesity (e.g., Prader-Willi Syndrome). 13. Body weight
change of more than 20% in either direction within the previous year.
14. Physician-prescribed diet, and/ or current, active member of an organized weight
loss program.
15. Diabetes mellitus (Types 1 & 2). 16. Diagnosis of epilepsy or use of
anti-epileptic medication within six months of starting the study (e.g. for the
treatment of peripheral neuropathy) 17. Chronic (more than a month of daily use)
treatment with opioid analgesic drugs within the last 6 months.
18. Regular use (more than twice a month) of anti-histamine medication within the last
6 months.
19. Use of oral or intravenous corticosteroid medication within 6 months of starting
the study.
20. Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of
starting the study.
21. Current alterations in treatment regimens of anti-depressant medication for
whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen
for prior 6 months acceptable).
22. An active diagnosis of cancer. 23. A myocardial infarction within the preceding
year. 24. 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).
25. Presence of permanently implanted battery powered medical device or stimulator
(e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve
stimulator etc.).
26. Psychiatric disorders (including untreated severe depression, schizophrenia,
substance abuse, eating disorder etc.) 27. Current participant in another weight loss
study or other clinical trial. 28. Have a family member who is currently participating
or is planning to participate in this study.
29. Pregnancy 30. History of migraine headaches
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