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

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

Tracking Information

• First Submitted Date: November 30, 2011
• First Posted Date: December 5, 2011
• Last Update Posted Date: December 14, 2017
• Study Start Date: January 2015
• Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Current 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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01485393 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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 (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; 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).
• 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
  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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 1, 2011): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2018
• Estimated Primary Completion Date: August 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: Kara Pavone, BS; kpavone@partners.org

• 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, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: National Institutes of Health (NIH)
• Investigators: Not Provided
• PRS Account: Massachusetts General Hospital
• Verification Date: December 2017