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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ramelteon 8 mg will be given once prior to a 2-hour nap |
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| 2 | Placebo Comparator | Placebo will be given once prior to a 2-hour nap |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | Ramelteon 8 mg tablet by mouth x 1 dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | total sleep time/time in bed * 100% (higher values indicate better outcome) | 2 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-nap Assessment - Visual Analog Scale | numerical scale of increasing alertness from 0-100 (higher values are better outcome) | 71 minutes |
| Post Nap Assessment - Karolinska Sleepiness Scale | numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shantha Rajaratnam, PhD | Brigham and Women's Hosptial | Principal Investigator |
| Elizabeth B Klerman, MD,PhD | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21206545 | Result | Cohen DA, Wang W, Klerman EB, Rajaratnam SM. Ramelteon prior to a short evening nap impairs neurobehavioral performance for up to 12 hours after awakening. J Clin Sleep Med. 2010 Dec 15;6(6):565-71. |
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Participants received 1 dose of ramelteon or placebo during the first inpatient visit and then returned approximately four weeks later for the other condition, counterbalanced for order
Healthy volunteers were recruited
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon in First Crossover Period | Ramelteon 8 mg will be given prior to a 2-hour nap |
| FG001 | Placebo in First Crossover Period | Placebo will be given prior to a 2-hour nap |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon in First Crossover Period | Ramelteon 8 mg will be given prior to a 2-hour nap |
| BG001 | Placebo in First Crossover Period | Placebo will be given prior to a 2-hour nap |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Efficiency | total sleep time/time in bed * 100% (higher values indicate better outcome) | All participants that completed both crossover periods | Posted | Mean | Standard Deviation | percent | 2 hours |
|
|
During each 28-hr inpatient study admission
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon | Ramelteon 8 mg will be given prior to a 2-hour nap |
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Circadian phase was not measured.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Cohen | Sentara Neurology Specialists | 757-388-6323 | dacohen@sentara.com |
| ID | Term |
|---|---|
| C495910 | ramelteon |
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| placebo | Drug | placebo identical in appearance to active experimental drug x 1 dose |
|
| 71 minutes |
| Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers) | A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score | 71 minutes |
| Post Nap Assessment - Karolinska Drowsiness Test | EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome | 71 minutes |
| Psychomotor Vigilance Task - Median Reaction Time | Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome) | 8 hours |
| Psychomotor Vigilance Task - Number of Lapses | Number of trials per test battery with a reaction time >0.5 seconds (higher values indicate worse outcome) | 8 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Other Pre-specified | Post-nap Assessment - Visual Analog Scale | numerical scale of increasing alertness from 0-100 (higher values are better outcome) | All participants that completed both crossover periods | Posted | Mean | Standard Deviation | units on a scale | 71 minutes |
|
|
|
| Other Pre-specified | Post Nap Assessment - Karolinska Sleepiness Scale | numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome) | All participants that completed both crossover periods | Posted | Mean | Standard Deviation | units on a scale | 71 minutes |
|
|
|
| Other Pre-specified | Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers) | A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score | All participants that completed both crossover periods | Posted | Mean | Standard Deviation | correct answers | 71 minutes |
|
|
|
| Other Pre-specified | Post Nap Assessment - Karolinska Drowsiness Test | EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome | All participants completing both crossover periods | Posted | Mean | Standard Deviation | microvolts^2/Hz | 71 minutes |
|
|
|
| Other Pre-specified | Psychomotor Vigilance Task - Median Reaction Time | Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome) | All participants completing both crossover periods | Posted | Mean | Standard Deviation | seconds | 8 hours |
|
|
|
| Other Pre-specified | Psychomotor Vigilance Task - Number of Lapses | Number of trials per test battery with a reaction time >0.5 seconds (higher values indicate worse outcome) | All participants completing both crossover periods | Posted | Mean | Standard Deviation | lapses | 8 hours |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Placebo will be given prior to a 2-hour nap | 0 | 10 | 0 | 10 |
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