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

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

Official Title
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Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Zolpidem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will receive both interventions in a randomized order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Control Subjects: Zolpidem, Then Dexmedetomidine<br>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. | Drug: Dexmedetomidine<br>* A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).<br>* Other names: Precedex;Drug: Zolpidem<br>* 12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).<br>|
| Experimental: Healthy Control Subjects: Dexmedetomidine, Then Zolpidem<br>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. | Drug: Dexmedetomidine<br>* A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).<br>* Other names: Precedex;Drug: Zolpidem<br>* 12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Quality | 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. | Approximately 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep | 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. | Approximately 30 minutes after waking up |