NCT03205631Unknown不适用
Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
IC-IT Sciences Inc.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
Prospective, randomized crossover study to compare the NFT sleep patches to sham device to assess sleep via home sleep testing device in the home environment
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •capacity to provide informed consent
- •between 30 and 65 years old
- •in overall good health as determined by history and physical assessment subjects pre-screened to ensure they are drug free
- •work a typical day job/work week.
- •not traveled > 3 time zones in the last month
- •typical bedtime between 9-12 PM
- •estimated on average 6 hours per night
- •negative urine drug screen
- •have self-reported unrefreshing sleep for the past month
- •agree to limit alcohol use to no more than two drinks a night during the testing period and four hours prior to bedtime
- •agree to limit caffeine consumption to four hours prior to bedtime
- •≤ 2 on the depression scale
- •≤ 3 on the anxiety scale
排除标准
- •pregnant or nursing a child
- •self-induced short sleep habits (<6 hours per night)
- •unstable medical conditions as determined by the clinician
- •current sleep disorder (sleep apnea AHI/REI<5, restless legs, periodic limb movements, narcolepsy)
- •self-reported sleep latency of >30 minutes or early (3-4 AM) awakenings on a regular basis
- •contact dermatitis to adhesives
- •excluded Medications: over the counter sleep aids, prescribed sleep aids, central nervous system stimulants, antidepressants, sedating antihistamines, over the counter decongestants and opioids
结局指标
主要结局
Sleep Quality
时间窗: three nights
Assess sleep via home EEG recording
次要结局
未报告次要终点
研究者
研究点 (2)
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