NCT01790256已完成不适用
A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cereve, Inc.
- 入组人数
- 144
- 试验地点
- 18
- 主要终点
- Polysomnographically determined sleep latency as changed from baseline measures
研究概览
简要总结
Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients. The current study is a two dose study to determine the optimal temperature for the Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and sleep efficiency.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 22
- •Diagnosis of insomnia that meets criteria for DSM IV diagnosis of primary insomnia and International Classification of Sleep Disorders (ICSD)general insomnia criteria and RDC insomnia disorder criteria
- •Subjects must remain alcohol-free and avoid drugs that could affect sleep during the study.
- •>14 on the Insomnia Severity Index
- •Sleep -Wake diaries demonstrate sleep efficiency <85% on at least 50% of nights
排除标准
- •Neuropsychiatric disorders that may independently affect sleep, brain function or cognition, such as current major syndromal psychiatric disorders, including DSM-IV mood, anxiety, psychotic, and substance use disorders.
- •Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.
- •Unstable medical conditions Raynaud's Disease
- •Irregular sleep schedules including shift workers;
- •A latency to persistent sleep < 15 on either the sleep disorder screening night or the baseline PSG sleep night;
- •A sleep efficiency > 85% on either the sleep disorder screening night or the baseline PSG sleep night;
- •An AHI (apnea hypopnea index) > 10 and/or a periodic limb movement arousal index (PLMAI) > 15 from SN1
- •Body Mass Index >34
- •Use of medications known to affect sleep or wake function
- •Consumption of more than one alcoholic drink per day, or more than 7 drinks per week prior to study entry.
- •Caffeinated beverages > 4/day or the equivalent of more than 4 cups of coffee Unable to read or understand English
结局指标
主要结局
Polysomnographically determined sleep latency as changed from baseline measures
时间窗: 1-2 weeks
Polysomnographically determined sleep parameters
Poloysomnographically determined sleep efficiency as changed from baseline measures
时间窗: 1-2 weeks
次要结局
未报告次要终点
研究者
研究点 (18)
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