NCT04627480进行中（未招募）4 期
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- ProofPilot
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in total sleep per night at week 4 between active and sham arm
研究概览
简要总结
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Sham Device
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 21 US resident Can receive packages to their home via UPS/Fedex/USPS Read/write English Insomnia Severity Index Score Greater than 14 Diagnosis of insomnia by a medical physician Subjects with a Generalized Anxiety Diagnosis will be excluded Have not contemplated suicide in the past year Not been institutionalized for mental health issues. Not currently being treated for or suspect a mental health issue Not currently experiencing problems with alcohol or drug abuse Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study Not taking medications affecting the nervous system (e.g. psychiatric medications) Not taking hypnotics or any sleep aid or marijuana (in any form) Can commit to one (1) 20 minute session per day for 8 weeks Has not used a brain stimulation treatment in one year No suspected or known history of heart disease No pacemaker, or any form of medical electronics, including but not limited to a deep brain stimulator, electronic stent, etc.
- •Not under medical supervision for other serious medical condition Not taking opioids No pain or headaches that interrupt sleep Not participating in any other sleep study Not experiencing restless leg syndrome No Nickel Allergy No Sleep Apena as measured by STOP-Bang Assessment
排除标准
- 未提供
结局指标
主要结局
Change in total sleep per night at week 4 between active and sham arm
时间窗: baseline versus week 4
Measured by Fitbit Charge 4 connected health device work on the wrist
次要结局
- Change in Insomnia Severity between Sham versus active arms(baseline versus week 4)
- Change in WASO (wake after sleep onset) between sham versus active arms(baseline versus week 4)
- Device Tolerance and Safety measured by SAFTEE(4 weeks from baseline)
研究者
研究点 (1)
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