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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Sponsor:
Massachusetts General Hospital
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
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Tracking Information | |||
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First Submitted Date ICMJE | November 30, 2011 | ||
First Posted Date ICMJE | December 5, 2011 | ||
Results First Submitted Date ICMJE | January 4, 2019 | ||
Results First Posted Date ICMJE | October 8, 2019 | ||
Last Update Posted Date | October 8, 2019 | ||
Study Start Date ICMJE | January 2015 | ||
Actual Primary Completion Date | January 29, 2018 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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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Original Secondary Outcome Measures ICMJE |
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.
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep | ||
Official Title ICMJE | 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 ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | 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 |
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Condition ICMJE | Insomnia | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
10 | ||
Original Estimated Enrollment ICMJE |
30 | ||
Actual Study Completion Date ICMJE | June 29, 2018 | ||
Actual Primary Completion Date | January 29, 2018 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Subjects will be deemed "Insomniacs" if they suffer from any of the following:
Exclusion Criteria: Primary Exclusion Criteria for "Healthy" control subjects:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 35 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01485393 | ||
Other Study ID Numbers ICMJE | 2011P-000715 DP1OD003646 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital | ||
Study Sponsor ICMJE | Massachusetts General Hospital | ||
Collaborators ICMJE | National Institutes of Health (NIH) | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Massachusetts General Hospital | ||
Verification Date | October 2019 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |