Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
NCT ID: NCT01485393
Last Updated: 2019-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2015-01-31
2018-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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.
Dexmedetomidine
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
Zolpidem
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
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.
Dexmedetomidine
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
Zolpidem
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
Interventions
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Dexmedetomidine
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
Zolpidem
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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).
18 Years
35 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Oluwaseun Johnson-Akeju, MD, MMSc
Assistant in Anesthaesia
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2011P-000715
Identifier Type: -
Identifier Source: org_study_id
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