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

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

Arms and Interventions

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).

Outcome Measures

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.

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

Locations

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:

Study Protocol and Statistical Analysis Plan  [PDF] November 9, 2017

More Information

• 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
• Results First Posted: October 8, 2019
• Last Update Posted: October 8, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

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