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

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ClinicalTrials.gov Identifier: NCT01485393
Recruitment Status : Recruiting
First Posted : December 5, 2011
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 30, 2011
First Posted Date  ICMJE December 5, 2011
Last Update Posted Date December 14, 2017
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01485393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
Performance on a word-pair cognitive task after waking up from sleep [ Time Frame: within 1-2hrs after waking up ]
The word pair task is a cognitive task geared towards understanding the effects of sleep on memory consolidation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Official Title  ICMJE Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Brief Summary The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Insomnia
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Experimental: Healthy Control Subjects
    This arm will be comprised of 15 healthy male and female controls.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Zolpidem
  • Experimental: Insomnia subjects
    This arm will be comprised of 15 male and female subjects with a sleep initiating and maintenance disorder.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Zolpidem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kara Pavone, BS kpavone@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01485393
Other Study ID Numbers  ICMJE 2011P-000715
DP1OD003646 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oluwaseun Johnson-Akeju, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP