A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control For Treatment Of Insomnia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 3
- 主要终点
- Insomnia Severity Index (ISI) score
研究概览
简要总结
Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of insomnia, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with insomnia.
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
- 18 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
- •Diagnosed insomnia with ISI of 15 or greater at screening
- •Males or females
- •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
- •Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial
- •Agreement not to use sleep trackers for the duration of the study (e.g sleep app smart watches)
- •Access to Wi-Fi (to connect iPod to internet)
排除标准
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required).
- •Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
- •Medication for insomnia (unless regime stable for last 3 months).
- •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.).
- •Previous use of any VeNS device
- •Participation in other clinical trials sponsored by Neurovalens
- •Have a member of the same household who is currently participating in this study.
- •History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:
结局指标
主要结局
Insomnia Severity Index (ISI) score
时间窗: 4 weeks
To evaluate the effect of the VeNS device, relative to control group on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia.
次要结局
- Number of adverse events(4 weeks)
- Quality of life using SF-36 scores(4 weeks)
- Quality of sleep using PSQI(4 weeks)