Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT01485393
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects will be deemed "Insomniacs" if they suffer from any of the following:
Exclusion criteria
Primary Exclusion Criteria for "Healthy" control subjects:
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
Other names: Precedex
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
Time frame: 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.
Time frame: 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.
Massachusetts General Hospital
Other
Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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