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

Mass General Brigham

Status: Completed

Conditions: Insomnia

Treatments: Drug: Dexmedetomidine; Drug: Zolpidem

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01485393

2011P-000715

DP1OD003646 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Healthy Control Subjects: Zolpidem, Then Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Zolpidem

Healthy Control Subjects: Dexmedetomidine, Then Zolpidem

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Zolpidem