Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 35 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Patients will receive both interventions in a randomized order.
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Healthy Control Subjects: Zolpidem, Then Dexmedetomidine
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.
  • Drug: Dexmedetomidine
    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
  • Drug: Zolpidem
    12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
Experimental
Healthy Control Subjects: Dexmedetomidine, Then Zolpidem
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.
  • Drug: Dexmedetomidine
    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
  • Drug: Zolpidem
    12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.