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

Arm | Intervention/treatment |
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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.
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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.
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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). |
- 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.
- 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 |
Inclusion Criteria:
- Primary Inclusion Criteria for "Insomniac" subjects:
Subjects will be deemed "Insomniacs" if they suffer from any of the following:
- 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.
- Subject will be required to not be on any current pharmacological sleep disorder treatment.
- Between the ages of 18 and 35 years.
- Not taking any prescription medications that alter sleep, cognitive functions, or both.
Exclusion Criteria:
Primary Exclusion Criteria for "Healthy" control subjects:
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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.
- A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.
- A score greater than or equal to 10 on the Epworth Sleepiness Scale.
- Takes medication that alters sleep, cognitive function, or both.
- Has a history of a known neurological or psychiatric problem.
- Younger than 18 or older than 35 years of age.
- Known or suspected sleep disorder(s).

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
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Documents provided by Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital:
Responsible Party: | Oluwaseun Johnson-Akeju, MD, MMSc, Assistant in Anesthaesia, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01485393 |
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 |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders 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 |