| January 7, 2008 |
| September 15, 2009 |
| December 2007 |
| November 2008 (final data collection date for primary outcome measure) |
- Sleep efficiency [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Neurobehavioral performance battery [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00595075 on ClinicalTrials.gov Archive Site |
| |
| |
| |
| Ramelteon Night Shift Study |
| Effects of Ramelteon on Sleep and Neurobehavioral Performance in a Simulated Night Shift Preceded by a Sleep Opportunity |
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:
- ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap;
- sleep inertia, as assessed by neurobehavioral tests and subjective and objective sleepiness assessments will not be significantly increased after ramelteon treatment compared with placebo treatment; and
- neurobehavioral performance, subjective and objective sleepiness, and subjective mood during a simulated 8-hour night shift will be significantly improved when ramelteon is given prior to a prophylactic nap compared to a prophylactic nap with placebo.
|
| |
| |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
| Healthy |
- Drug: Ramelteon
- Drug: placebo
|
- Experimental: Ramelteon 8mg will be given prior to a 2-hour nap
- Placebo Comparator: Placebo will be given prior to a 2-hour nap
|
| |
| |
| Completed |
| 10 |
| November 2008 |
| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Aged between 18-35 years;
- Non-smoking for at least 6 months;
- Healthy (no medical, psychiatric or sleep disorders);
- No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, and ECG;
- Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative serum pregnancy test;
- Body mass index of > 18 or < 30 kg/m2;
- No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
- Habitual caffeine consumption < 300mg per day on average;
- Habitual alcohol consumption < 10 alcoholic units per week on average.
Exclusion Criteria:
- History of alcohol or substance abuse;
- Positive result on drugs of abuse screening;
- Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
- Psychiatric disorder, including a history of depression or dysthymia (characterized by depressed mood on the majority of days for at least two years);
- Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
- History of intolerance or hypersensitivity to melatonin or melatonin agonists;
- Pregnancy or lactation;
- Shift work;
- Transmeridian travel (2 or more time zones) in past 2 months;
- Any other scientific or medical reason, as determined by the PI, such as non-compliance with protocol or intolerance to inpatient study conditions.
|
| Both |
| 18 Years to 35 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00595075 |
| Elizabeth Klerman, MD, PhD/Shantha Rajaratnam, PhD, Brigham and Women's Hospital |
| Takeda - 103113 |
| Brigham and Women's Hospital |
| Takeda Global Research & Development Center, Inc. |
| Principal Investigator: |
Shantha Rajaratnam, PhD |
Brigham and Women's Hosptial |
|
| Principal Investigator: |
Elizabeth B Klerman, MD,PhD |
Brigham and Women's Hospital |
|
|
| Brigham and Women's Hospital |
| September 2009 |