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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 : Completed
First Posted : December 5, 2011
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients will receive both interventions in a randomized order.
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
Actual Primary Completion Date : January 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: Precedex

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




Primary Outcome Measures :
  1. 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 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. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.



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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485393


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
  Study Documents (Full-Text)

Documents provided by Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital:

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Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, 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    Key Record Dates
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Zolpidem
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Dexmedetomidine
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