Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Nocturnal Sleep Length at 1 Month
研究概览
简要总结
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
- •Subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made by either the potential participant or by the caregiver.
排除标准
- •Participation in any other clinical drug trial
- •Liver failure
- •Believed by the investigator to be unwilling or unable to follow the protocol
- •Active liver or coronary disease
研究组 & 干预措施
Modafinil
干预措施: modafinil (Drug)
结局指标
主要结局
Nocturnal Sleep Length at 1 Month
时间窗: 1 month
次要结局
- Improvement of Daytime Alertness and Quality of Life.(~1 month)
研究者
Jamie M. Zeitzer, Ph.D.
Assistant Professor
VA Palo Alto Health Care System