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

Tracking Information

• First Submitted Date: November 30, 2011
• First Posted Date: December 5, 2011
• Results First Submitted Date: January 4, 2019
• Results First Posted Date: October 8, 2019
• Last Update Posted Date: October 8, 2019
• Study Start Date: January 2015
• Actual Primary Completion Date: January 29, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 7, 2019)

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.

Original Primary Outcome Measures (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.

Current Secondary Outcome Measures (submitted: October 7, 2019)

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.

Original Secondary Outcome Measures (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: Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Insomnia

Intervention

• 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).

Study Arms

• 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.
  Interventions:

  • Drug: Dexmedetomidine
  • Drug: Zolpidem
• 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.
  Interventions:

  • Drug: Dexmedetomidine
  • Drug: Zolpidem

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2019): 10
• Original Estimated Enrollment (submitted: December 1, 2011): 30
• Actual Study Completion Date: June 29, 2018
• Actual Primary Completion Date: January 29, 2018 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01485393
• Other Study ID Numbers: 2011P-000715; DP1OD003646 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: National Institutes of Health (NIH)
• Investigators: Not Provided
• PRS Account: Massachusetts General Hospital
• Verification Date: October 2019