NCT04110717已完成不适用
Electrical Vestibular Nerve Stimulation (VeNS) Together With a Lifestyle Modification Program, Compared to a Sham Control With a Lifestyle Modification Program, as a Means of Reducing Excess Body Weight and Body Fat.
Neurovalens Ltd.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total body weight loss
研究概览
简要总结
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 programme, as a means of reducing excess body weight and body fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 25 kg/m2
- •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).
- •18-80 years of age inclusive on starting the study.
- •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 for the duration of the study.
- •Access to Wi-Fi (to connect iPod to internet)
排除标准
- •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 or marijuana smoking in the 6 months before starting and for the duration of the study.
- •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 participant in another weight loss study or other clinical trial.
- •Have a family member who is currently participating or is planning to participate in this study.
- •History of migraine headaches
结局指标
主要结局
Total body weight loss
时间窗: 12 weeks
In kg
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of VeSTAL Device in Type 2 Diabetes MellitusMetabolic SyndromeType 2 DiabetesNCT04149951Neurovalens Ltd.50
已完成
不适用
Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical TrialObesityNCT05275790Neurovalens Ltd.10
已完成
不适用
Vestibular Nerve Stimulation to Improve SleepSleepSleep Disorders, Circadian RhythmInsomniaNCT04219566Neurovalens Ltd.80
已完成
不适用
Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical TrialObesityNCT03640286Neurovalens Ltd.241
已完成
不适用
Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term UsageSafety IssuesNCT04783883Neurovalens Ltd.25