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



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 35
Updated:12/16/2017
Start Date:January 2015
End Date:August 2018
Contact:Kara Pavone, BS
Email:kpavone@partners.org

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

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


Inclusion Criteria:

- Primary Inclusion Criteria for "Insomniac" subjects:

Subjects will be deemed "Insomniacs" if they suffer from any of the following:

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:

Primary Exclusion Criteria for "Healthy" control subjects:

1. 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.

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).
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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