Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Sleep Quality
研究概览
简要总结
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary Inclusion Criteria for "Insomniac" subjects:
- •Subjects will be deemed "Insomniacs" if they suffer from any of the following:
- •Subject will be required to meet the criteria for insomnia, set by the International Classification of Sleep Disorders, which requires that a patient have difficulty initiating or maintaining sleep that is not accounted for by another sleep disorder, neurologic or psychiatric disorder or substance or medication.
- •Subject will be required to not be on any current pharmacological sleep disorder treatment.
- •Between the ages of 18 and 35 years.
- •Not taking any prescription medications that alter sleep, cognitive functions, or both.
排除标准
- •Primary Exclusion Criteria for "Healthy" control subjects:
- •Abnormal sleep habits:
- •sleeping less than 5 hours each night;
- •going to sleep before 9:00 PM or after 2:00 AM on a regular basis; or
- •Waking up before 5:00 AM or after 10:00 AM on a regular basis. This will be objectively assessed by wrist actigraphy measured for a 1-week duration prior to the first study night.
- •A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.
- •A score greater than or equal to 10 on the Epworth Sleepiness Scale.
- •Takes medication that alters sleep, cognitive function, or both.
- •Has a history of a known neurological or psychiatric problem.
- •Younger than 18 or older than 35 years of age.
- •Known or suspected sleep disorder(s).
研究组 & 干预措施
Healthy Control Subjects: Zolpidem, Then Dexmedetomidine
This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.
干预措施: Dexmedetomidine (Drug)
Healthy Control Subjects: Zolpidem, Then Dexmedetomidine
This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.
干预措施: Zolpidem (Drug)
Healthy Control Subjects: Dexmedetomidine, Then Zolpidem
This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.
干预措施: Dexmedetomidine (Drug)
Healthy Control Subjects: Dexmedetomidine, Then Zolpidem
This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.
干预措施: Zolpidem (Drug)
结局指标
主要结局
Change in Sleep Quality
时间窗: Approximately 8 hours
Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.
次要结局
- Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep(Approximately 30 minutes after waking up)
研究者
Oluwaseun Johnson-Akeju, MD, MMSc
Assistant in Anesthaesia
Massachusetts General Hospital