NCT05845658已完成不适用
A Randomized, Double-Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety
Neurovalens Ltd.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月25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
- 60
- 试验地点
- 2
- 主要终点
- Generalised Anxiety Disorder (GAD-7) Scores
研究概览
简要总结
The present study will be conducted at the Department of Physiology in collaboration with the Department of Psychiatry of R.D. Gardi Medical College, Ujjain, Madhya Pradesh.
This double-blind randomized controlled trial will remotely enroll 60 subjects. Each participant will complete 20 stimulation sessions at a rate of 3-5 sessions per week. Each session will be 30 minutes on the day of usage. The study will be randomized with a 1:1 active; or sham control allocation. Endpoint analysis will be performed upon completion of the study.
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)
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)
- •Males or females 18-80 years of age inclusive on starting the study
- •Can speak/read English
- •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
- •Not using, and have never used, prescription, or the counter, anxiety medications
- •Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes
排除标准
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- •Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent the Modius Stress device from working)
- •Medication for anxiety
- •Use of beta-blockers within 1 month of starting the study
- •Use of antidepressants or unstable dose within 3 months of starting study
- •Use of any other medical condition or medication use that in the opinion of the PI is likely to make the participant resistant to VeNS.
- •A score higher than 14 on the Insomnia Severity Index (ISI)
- •A history of stroke or severe head injury (as defined by a head injury that required a 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.).
- •Pregnancy or breast-feeding or intends to become pregnant (a pregnancy kit can be mailed if any uncertainty)
- •History of epilepsy
- •History of active migraines with aura
- •History of head injury requiring intensive care or neurosurgery
- •History of diagnosed cognitive impairment such as Alzheimer's disease/dementia
- •History of bipolar, psychotic or substance use disorders
- •Diagnosis of a current psychotic disorder
- •Regular use (more than twice a month) of antihistamine medication within the last 6 months.
- •History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- •A diagnosis of myelofibrosis or myelodysplastic syndrome.
- •Previous use of any VeNS device
- •Participation in other clinical trials
- •History of vestibular dysfunction or another inner ear disease
结局指标
主要结局
Generalised Anxiety Disorder (GAD-7) Scores
时间窗: Up to 6 weeks
To evaluate the ability of the Modius Stress device, relative to the control group, in the management of anxiety.
次要结局
- Number of adverse events(Up to 6 weeks)
- Quality of life using SF-36 scores(Up to 6 weeks)
- Insomnia Severity Index (ISI) score(Up to 6 weeks)
研究者
研究点 (2)
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