Status:
COMPLETED
Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Insomnia
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01485393
Start Date
January 1 2015
End Date
June 29 2018
Last Update
October 8 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114