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Sponsors and Collaborators: |
Brigham and Women's Hospital Takeda Global Research & Development Center, Inc. |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00595075 |
Night shift-workers are often advised to take a prophylactic nap prior to starting the shift in order to improve alertness and performance. However, individuals often report difficulty initiating and maintaining sleep at that time of the day secondary to the alerting influence of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may improve the quality of an evening nap and subsequent alertness and performance during a night shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order to test the following hypotheses:
Condition | Intervention |
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Healthy |
Drug: Ramelteon Drug: placebo |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effects of Ramelteon on Sleep and Neurobehavioral Performance in a Simulated Night Shift Preceded by a Sleep Opportunity |
Estimated Enrollment: | 10 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ramelteon 8mg will be given prior to a 2-hour nap
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Drug: Ramelteon
Ramelteon 8mg tablet by mouth x 1 dose
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2: Placebo Comparator
Placebo will be given prior to a 2-hour nap
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Drug: placebo
placebo identical in appearance to active experimental drug
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Row | 617-525-6542 | nightshift@ric.bwh.harvard.edu |
Contact: Daniel A Cohen, MD | 617-732-5206 | dcohen1@partners.org |
United States, Massachusetts | |
Brigham and Woman's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Shantha Rajaratnam, PhD | Brigham and Women's Hosptial |
Principal Investigator: | Elizabeth B Klerman, MD,PhD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Elizabeth Klerman, MD, PhD/Shantha Rajaratnam, PhD ) |
Study ID Numbers: | Takeda - 103113 |
Study First Received: | January 7, 2008 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00595075 |
Health Authority: | United States: Institutional Review Board |
sleep performance night shift Ramelteon Healthy Individuals |
Healthy |