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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01485393
First received: November 30, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Insomnia
Drug: Dexmedetomidine
Drug: Zolpidem

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Subjective and objective measures of sleep quality [ Time Frame: approximately 8 hours ] [ Designated as safety issue: No ]
    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:
  • Performance on a word-pair cognitive task after waking up from sleep [ Time Frame: within 1-2hrs after waking up ] [ Designated as safety issue: No ]
    The word pair task is a cognitive task geared towards understanding the effects of sleep on memory consolidation.


Estimated Enrollment: 30
Study Start Date: January 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485393

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

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Kara Pavone, BS       kpavone@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

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
Study First Received: November 30, 2011
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Zolpidem
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on October 19, 2014