Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Not Applicable

Completed

Brief Summary: The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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).

Arm && Interventions

Group	Intervention	Description
Healthy Control Subjects: Zolpidem, Then Dexmedetomidine	Zolpidem	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.
Healthy Control Subjects: Dexmedetomidine, Then Zolpidem	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.
Healthy Control Subjects: Dexmedetomidine, Then Zolpidem	Dexmedetomidine	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.
Healthy Control Subjects: Zolpidem, Then Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Change in Sleep Quality	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.

Secondary Outcome Measures

Name	Time	Method
Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep	Approximately 30 minutes after waking up	The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.