Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
This trial is active, not recruiting.
|Sponsor||Massachusetts General Hospital|
|Collaborator||National Institutes of Health (NIH)|
|Start date||January 2015|
|End date||August 2017|
|Trial size||30 participants|
|Trial identifier||NCT01485393, 2011P-000715, DP1OD003646|
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
|Intervention model||crossover assignment|
|Primary purpose||basic science|
Subjective and objective measures of sleep quality
time frame: Approximately 8 hours
Performance on a Psychomotor Vigilance Test (PVT) after waking up from sleep
time frame: Approximately 30 minutes after waking up
All participants from 18 years up to 35 years old.
- 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.
- 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).
|Official title||Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep|
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