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

Overview

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

Full Title of Study: “Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 29, 2018

Interventions

  • 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).
  • Drug: Zolpidem
    • 12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Sleep Quality
    • Time Frame: Approximately 8 hours
    • Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep–all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.

Secondary Measures

  • Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep
    • Time Frame: Approximately 30 minutes after waking up
    • The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Oluwaseun Johnson-Akeju, MD, MMSc, Assistant in Anesthaesia – Massachusetts General Hospital

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