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

• Sponsor: Massachusetts General Hospital
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Oluwaseun Johnson-Akeju, Massachusetts General Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Insomnia	Drug: Dexmedetomidine; Drug: Zolpidem	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
• Study Start Date: January 2015
• Estimated Primary Completion Date: August 2018
• Estimated Study Completion Date: August 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Healthy Control Subjects; This arm will be comprised of 15 healthy male and female controls.	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).
Experimental: Insomnia subjects; This arm will be comprised of 15 male and female subjects with a sleep initiating and maintenance disorder.	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).

Outcome Measures

Primary Outcome Measures :

1. Subjective and objective measures of sleep quality [ Time Frame: Approximately 8 hours ]
   Sleep quality will be assessed by both objective and subjective measures. The objective measures will comprise of total sleep time, number of awakenings overnight, sleep latency, normal sleep architecture on EEG. Subjective measures will utilize a post sleep questionnaire to assess the subjects feelings of being well rested.

Secondary Outcome Measures :

1. 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
2. Performance on a Motor Sequence Task (MST) after waking up from sleep [ Time Frame: Approximately 30 minutes after waking up ]
   The MST is a measure of cognitive function

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Contacts

Contact: Kara Pavone, BS; kpavone@partners.org

Locations

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Kara Pavone, BS kpavone@partners.org

Sponsors and Collaborators

Massachusetts General Hospital

National Institutes of Health (NIH)

More Information

• Responsible Party: Oluwaseun Johnson-Akeju, Assistant in Anesthaesia, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01485393 History of Changes
• Other Study ID Numbers: 2011P-000715; DP1OD003646 ( U.S. NIH Grant/Contract )
• First Posted: December 5, 2011
• Last Update Posted: December 14, 2017
• Last Verified: December 2017

Additional relevant MeSH terms:

Dexmedetomidine; Zolpidem; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; GABA Agents