Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Purpose
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
Condition
- Insomnia
Eligibility
- Eligible Ages
- Between 18 Years and 35 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Primary Inclusion Criteria for "Insomniac" subjects: Subjects will be deemed "Insomniacs" if they suffer from any of the following: 1. 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. 2. Subject will be required to not be on any current pharmacological sleep disorder treatment. 3. Between the ages of 18 and 35 years. 4. Not taking any prescription medications that alter sleep, cognitive functions, or both.
Exclusion Criteria
Primary Exclusion Criteria for "Healthy" control subjects: 1. 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. 2. A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy. 3. A score greater than or equal to 10 on the Epworth Sleepiness Scale. 4. Takes medication that alters sleep, cognitive function, or both. 5. Has a history of a known neurological or psychiatric problem. 6. Younger than 18 or older than 35 years of age. 7. Known or suspected sleep disorder(s).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Patients will receive both interventions in a randomized order.
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 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. |
|
Experimental 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. |
|
More Details
- Status
- Completed
- Sponsor
- Massachusetts General Hospital